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Key Responsibilities:Foster a strong Supplier Quality Culture by leading or contributing to process improvement initiatives that enhance our quality programs and procedures—setting our Global Partner Network up for success. Employ relevant quality tools (such as Lean and Six Sigma) to address issues related to non-conformances and Customer RMAs. Oversee supplier-related NCR/SCAR/CAR activities to ensure timely management and documentation. Ensure adherence to company policies, practices, and procedures to uphold an AS9100-compliant environment.
About the job
At Xometry (NASDAQ: XMTR), we empower the industries of today and tomorrow by connecting visionary thinkers with manufacturers capable of turning their ideas into reality. Our digital marketplace equips manufacturers with the essential tools to expand their businesses while providing Fortune 1000 companies seamless access to global manufacturing capabilities.
We are on the lookout for dynamic Quality Engineers to join our team and support our rapid growth. Are you someone who thrives in challenging environments? Do you aspire to revolutionize an industry? If your strength lies in prioritizing tasks and communicating effectively, then this role could be your next great adventure.
As a Quality Assurance Engineer, you will collaborate with a fast-paced team of engineering experts to address quality assurance challenges for customized parts. You will also assist the Senior Director in developing our quality systems in line with corporate policies and AS9100 standards.
About Xometry
Xometry is at the forefront of the manufacturing revolution, providing innovative solutions that connect creative minds with the resources they need. Our platform empowers manufacturers, allowing them to thrive in a competitive marketplace while offering unmatched service to buyers from major corporations.
About the Role New England Donor Services is seeking a Quality Systems Specialist I in Waltham. This entry-level position supports the organization’s commitment to quality by helping to develop, implement, and maintain quality systems that meet industry regulations and standards. What You Will Do Assist with the creation and improvement of quality systems an…
Full-time|$43.27/hr - $57.69/hr|On-site|Waltham, Massachusetts, United States
ElevateBio develops and manufactures advanced therapies, working with partners from early stages through to commercialization. The company combines a range of technologies, services, and manufacturing expertise to help advance new therapies efficiently. Role overview The Quality Assurance Validation Specialist I will join the QA Validation Group and focus on Commissioning and Qualification (CQV) activities for quality control laboratories, manufacturing suites, and related equipment. This position supports quality assurance within a cGMP environment. Main responsibilities Oversee QA activities for CQV processes in cGMP manufacturing facilities and quality control labs. Manage QA oversight for periodic reviews and requalification programs. Review Computerized Maintenance Management System (CMMS) records for asset management, including asset release, database requests, and work orders. Provide QA oversight for quality events related to validation and engineering, such as deviations and CAPAs. Contribute feedback as part of cross-functional teams on inspection readiness activities. Author and review Standard Operating Procedures (SOPs) in Veeva. Requirements Strong understanding of Commissioning and Qualification processes for laboratory and manufacturing environments, including equipment and instrumentation. This role is based in Waltham, Massachusetts.
Full-time|$86K/yr - $114K/yr|On-site|Waltham, Massachusetts, United States
About Anduril Industries Anduril Industries develops advanced defense technology for the U.S. and allied militaries. The company focuses on delivering autonomy, artificial intelligence, computer vision, sensor integration, and communication systems. Anduril’s products run on Lattice OS, a platform that turns large data streams into a 3D command and control interface. The team aims to bring new capabilities to the field in months rather than years. Role Overview: Material Operations Specialist Based in Waltham, Massachusetts, the Material Operations Specialist works alongside Field Operations leadership to ensure the right hardware reaches each mission. This position calls for strong problem-solving skills, attention to detail, and the ability to work well with others. Success in this role relies on knowledge of logistics, hardware operations, and cross-functional project management. Main Responsibilities Assist with receiving, identifying, and documenting inventory.
Full-time|On-site|Waltham, Massachusetts, United States
This Associate II, Quality Control role at elevatebio focuses on maintaining rigorous quality standards for products and processes. The position is located in Waltham, Massachusetts and supports the company's commitment to compliance and operational excellence. Key Responsibilities Perform quality assessments to ensure both compliance and consistency across operations. Implement established quality control procedures throughout daily activities. Collaborate with colleagues from various departments to address regulatory requirements. Identify opportunities for process improvement and contribute to strengthening quality systems. Requirements Strong analytical skills for reviewing data and evaluating processes. Close attention to detail when handling quality documentation and procedures. Background in regulated environments is considered valuable.
Join Artech Information Systems LLC as a Scientist I, where you will embark on a scientific journey in a dynamic and supportive environment. This entry-level position is an excellent opportunity for recent graduates or those new to the field of science to apply their knowledge and skills in a practical setting. You will engage in research, data analysis, and collaboration with seasoned professionals, contributing to innovative projects that make a difference.
At Xometry (NASDAQ: XMTR), we empower the industries of today and tomorrow by connecting visionary thinkers with manufacturers capable of turning their ideas into reality. Our digital marketplace equips manufacturers with the essential tools to expand their businesses while providing Fortune 1000 companies seamless access to global manufacturing capabilities.We are on the lookout for dynamic Quality Engineers to join our team and support our rapid growth. Are you someone who thrives in challenging environments? Do you aspire to revolutionize an industry? If your strength lies in prioritizing tasks and communicating effectively, then this role could be your next great adventure.As a Quality Assurance Engineer, you will collaborate with a fast-paced team of engineering experts to address quality assurance challenges for customized parts. You will also assist the Senior Director in developing our quality systems in line with corporate policies and AS9100 standards.
Full-time|$112K/yr - $178K/yr|On-site|Waltham, Massachusetts, United States
The Elevator PitchEvolv Technology is dedicated to enhancing global safety through innovative, AI-driven security solutions. We are looking for a meticulous and commercially adept Senior Contracts Manager to join our Legal Team in its mission to expand the business while fostering a culture of creativity, ongoing learning, and adherence to compliance.This is an exceptional opportunity to contribute to an extraordinarily talented Legal Team supporting a rapidly growing, mission-focused public company that operates at the forefront of physical security and state-of-the-art technology. In this critical role, you will oversee the complete lifecycle of commercial contracts, ensure compliance with industry regulations, and assist our sales and procurement teams in executing deals efficiently and responsibly. You will collaborate with stakeholders across various departments, and your insights and contributions will have an immediate impact due to the size of both the Legal Team and the company.The ideal candidate merges a solid understanding of the contracting and go-to-market processes with a practical business perspective, a keen interest in emerging technologies, and a commitment to facilitating responsible innovation. This position is perfectly suited for someone who flourishes at the intersection of law, business, and process optimization, and is eager to grow alongside Evolv.
Contract|On-site|Waltham, Massachusetts, United States
Join Acorn Product Development, a leading product engineering services firm, dedicated to empowering global companies through innovative engineering solutions. Our collaborative approach enables us to tackle complex engineering challenges, streamline supply chains, and optimize manufacturing and delivery processes. With our extensive expertise and established relationships, we assist clients in launching innovative, reliable, and cost-effective products that make a significant impact in their respective markets.We are currently seeking experienced Mechanical Engineers (contractors) to join our dynamic team in Waltham, MA. Local candidates are preferred.
Full-time|$219.2K/yr - $219.2K/yr|On-site|Waltham, MA
Zenas BioPharma is a pioneering clinical-stage biopharmaceutical company dedicated to becoming a frontrunner in the development and commercialization of groundbreaking therapies aimed at treating autoimmune diseases. Our strategic approach combines the expertise of our seasoned leadership team with a focused product candidate acquisition strategy to identify, acquire, and develop globally impactful product candidates that can deliver exceptional clinical benefits to patients affected by autoimmune conditions. Currently, Zenas is advancing two late-stage molecules, obexelimab and orelabrutinib. Obexelimab, our leading candidate, is a bifunctional monoclonal antibody targeting CD19 and FcγRIIb, crucial components in the B cell lineage, designed to inhibit the activity of specific cells involved in autoimmune disorders without depleting them. We believe that obexelimab’s innovative mechanism and self-administered, subcutaneous injection method will effectively address the pathogenic role of B cells in chronic autoimmune diseases. Orelabrutinib is a highly selective, CNS-penetrant oral Bruton’s Tyrosine Kinase (BTK) inhibitor that shows promise in managing compartmentalized inflammation and disease progression in Multiple Sclerosis (MS). Our earlier-stage projects include a preclinical oral IL-17AA/AF inhibitor and a preclinical oral brain-penetrant TYK2 inhibitor.We are in search of exceptional talent who share our passion for patient care and possess a proven track record in acquiring, developing, and commercializing global products. Joining Zenas offers the opportunity to thrive in a dynamic learning environment and achieve personal and organizational success as we strive to become a leader in immunology and autoimmune disease treatment, while upholding our values of Transparency, Relationships, Urgency, Excellence, and Innovation—embracing TRUE Innovation!Position Summary:The Senior Director of Pricing and Contracting will spearhead the development and implementation of the U.S. pricing and contracting strategy to ensure optimal market access, reimbursement, and financial performance for Zenas BioPharma’s portfolio. This role includes crafting contracting strategies with national and regional payer organizations, pharmacy benefit managers (PBMs), and government payers. Reporting directly to the Vice President of U.S. Market Access, the individual will oversee pricing strategy formulation, gross-to-net modeling, and payer contracting strategies that will support both product launch initiatives and lifecycle management.
Full-time|$213K/yr - $240K/yr|Remote|Waltham, Massachusetts, United States
About Us:At Oruka Therapeutics (Nasdaq: ORKA), we are pioneering innovative biologics aimed at transforming the treatment landscape for chronic skin disorders. Our mission is to empower individuals battling chronic skin conditions, such as plaque psoriasis, by providing them with the utmost freedom from their ailments, achieving significant disease clearance through infrequent dosing, potentially just once or twice yearly. Our proprietary collection of antibodies, meticulously crafted by Paragon Therapeutics, targets the fundamental mechanisms of plaque psoriasis and other dermatological and inflammatory conditions. To learn more, visit www.orukatx.com.As we expand our core team, we are on the lookout for exceptional talent across various functional areas—individuals who seek more than just employment, but rather a chance to be part of something transformative. We value passion for making a difference and contributions to fostering an engaged, inclusive, and positive workplace culture.Job Title: Director of Clinical Quality AssuranceLocation: Remote; candidates located in the Waltham, MA area are preferred.Role Overview:The Director of Clinical Quality Assurance will provide strategic leadership and oversight for Oruka's clinical development initiatives, focusing primarily on Good Clinical Practice (GCP) and associated quality systems that support clinical trials. This role will establish, enhance, and oversee clinical quality processes appropriate to each phase, ensuring comprehensive supervision of clinical trial execution and vendor performance while preparing for global health authority inspections, including FDA Bioresearch Monitoring (BIMO) inspections.This position will collaborate closely with Clinical Operations, Clinical Development, Biometrics, Pharmacovigilance, Regulatory Affairs, Medical Writing, and external service providers to ensure compliance with GCP, relevant global regulations, internal procedures, and protocol requirements throughout the clinical trial lifecycle. The Director of Clinical QA will proactively contribute quality insights, support continuous improvement initiatives, and help cultivate a quality-centric culture as the organization progresses with its pipeline.Key Responsibilities:Clinical Quality Oversight: Ensure compliance with GCP and applicable regulatory requirements for new and ongoing clinical studies.
Full-time|On-site|Waltham, Massachusetts, United States
Join our dynamic legal team as a Contracts Administrator / Legal Associate, where your expertise will play a vital role in ensuring compliance and managing contracts effectively. You will work closely with various departments to facilitate contract review, negotiation, and execution while maintaining the highest standards of accuracy and efficiency.
About the Role Zenas Bio is looking for a Director of Global Quality Assurance with expertise in Good Clinical Practice (GCP) and Good Laboratory Practice (GLP). This leader will guide the company’s quality assurance activities and maintain compliance with regulatory standards. Key Responsibilities Oversee global quality assurance processes related to GCP and GLP. Ensure all practices meet current regulatory requirements and industry standards. Location This position is based in Waltham, MA.
Deciphera Pharmaceuticals, Inc. is hiring a Senior Manager, Clinical Quality Assurance in Waltham. This position leads the Clinical Quality Assurance team and plays a central role in maintaining high standards for clinical trial quality and regulatory compliance. Role Overview The Senior Manager, Clinical Quality Assurance develops and implements quality assurance strategies for clinical programs. The role involves oversight of compliance with regulatory requirements and internal quality expectations throughout all phases of clinical trials. Key Responsibilities Lead the Clinical Quality Assurance team Develop and execute quality assurance strategies for clinical trials Conduct audits to assess compliance with regulatory standards Ensure all clinical trial activities meet regulatory and company quality requirements What We’re Looking For Extensive experience in clinical quality assurance Strong knowledge of regulatory requirements for clinical trials Proven ability to develop and implement quality assurance processes Experience conducting audits in a clinical setting
Role overview Boston Engineering Corporation seeks a Senior Electrical Engineer specializing in embedded systems and controls. This full-time position is based in Waltham and centers on designing and developing electrical solutions for a variety of projects. What you will do Design and develop electrical systems tailored to embedded and control applications Collaborate with engineers from different disciplines to integrate solutions Apply technical expertise to projects serving multiple industries Team and impact This role works closely with a skilled engineering team to deliver solutions that support client innovation. Projects span several industries, contributing to ongoing advancements at Boston Engineering Corporation.
We are seeking a passionate and detail-oriented Quality Assurance Analyst to join our dynamic team in Waltham. In this role, you will play a critical part in ensuring the quality and reliability of our software products through rigorous testing and analysis. You will collaborate closely with developers and project managers to identify issues and recommend solutions, contributing to our commitment to excellence.
At Crescent Biopharma, we aspire to transform the landscape of oncology by developing cutting-edge therapies tailored for cancer patients. Our innovative pipeline includes a leading PD-1 x VEGF bispecific antibody, alongside state-of-the-art antibody-drug conjugates. By harnessing diverse therapeutic modalities and established targets, we aim to expedite the development of potentially groundbreaking treatments, whether as standalone interventions or in combination therapies targeting various solid tumors. For more insights into our mission and vision, visit our website and connect with us on LinkedIn and X.We are currently in search of an Associate Director or Director of Analytical & GMP Quality Assurance Operations. In this pivotal role, you will oversee and guide the QA functions related to analytical development, quality control operations, and GMP quality activities across our clinical-stage biologics and ADC programs. Collaboration with cross-functional teams, including CMC, Analytical Sciences, Quality Control, and Technical Operations, as well as external manufacturing and testing partners, will be key to ensuring compliance with phase-appropriate GMP standards, maintaining data integrity, and ensuring inspection readiness within a dynamic outsourced operational framework. Your strategic vision will be instrumental in shaping Crescent's analytical quality strategy and driving the disciplined execution of core quality systems that align with our aggressive development timelines.
Full-time|$140.8K/yr - $176K/yr|On-site|Waltham, MA
Zenas BioPharma is a pioneering biopharmaceutical company at the forefront of developing and commercializing transformative therapies for patients suffering from autoimmune diseases. Our strategic approach combines a seasoned leadership team with a rigorous process for acquiring and developing innovative product candidates globally. We are focused on delivering superior clinical benefits to patients affected by autoimmune disorders. We are advancing two late-stage flagship molecules: obexelimab and orelabrutinib. Obexelimab is our lead candidate, a bifunctional monoclonal antibody targeting CD19 and FcγRIIb, aimed at inhibiting the activity of pathogenic B cells without causing depletion. This innovative therapy offers a self-administered subcutaneous injection regimen, addressing chronic autoimmune diseases effectively. Orelabrutinib, on the other hand, is a highly selective oral small molecule Bruton’s Tyrosine Kinase (BTK) inhibitor, designed to tackle compartmentalized inflammation and disease progression in Multiple Sclerosis (MS). We also have promising earlier-stage programs, including a preclinical oral IL-17AA/AF inhibitor and a brain-penetrant TYK2 inhibitor.We are on the lookout for exceptional talent who share our dedication to improving patient outcomes and possess a proven track record in global product acquisition, development, and commercialization. Joining Zenas provides an opportunity to thrive in a dynamic learning environment where individual and organizational success is paramount as we aspire to become a global leader in immunology and autoimmune disease management. Our core values—Transparency, Relationships, Urgency, Excellence, and Innovation—drive us toward TRUE Innovation!Position Summary:As the Senior Manager of Global Quality Assurance for Technical Operations, you will report directly to the Director of Global Quality Assurance for Medical Devices and Combination Products. This strategic role encompasses hands-on quality oversight for late clinical-stage and commercial manufacturing activities at Zenas BioPharma’s Contract Manufacturing Organizations (CMOs). You will ensure the highest standards of GMP compliance across our global operations, facilitate regulatory submissions and inspections, and drive continuous improvement initiatives alongside internal teams and external manufacturing partners. Your responsibilities will include overseeing batch manufacturing and testing, process validation, and ensuring inspection readiness to maintain robust product quality throughout the development lifecycle.
Join our dynamic team at Integrated Resources Inc. as an eBilling and Database Specialist. In this role, you will be responsible for managing electronic billing processes and maintaining the integrity of our database systems. Your analytical skills will be essential in ensuring accurate billing and data management.We are looking for a detail-oriented professional who thrives in a fast-paced environment and can effectively collaborate with various teams to streamline our eBilling operations.
Join Crescent Biopharma as a Senior Director of R&D Quality Assurance!Crescent Biopharma is on a mission to revolutionize oncology by developing cutting-edge therapies for cancer patients. Our clinical-stage pipeline showcases our leading program, a PD-1 x VEGF bispecific antibody, alongside innovative antibody-drug conjugates. Through the strategic utilization of diverse modalities and established therapeutic targets, we aim to swiftly propel potentially transformative treatments, whether as standalone therapies or in combination regimens targeting a variety of solid tumors.As a key leader in our Quality organization, the Senior Director, R&D Quality (GCP–GLP–GvP) will deliver both strategic and hands-on leadership in Quality Assurance across clinical and nonclinical domains.
Join our dynamic team as a Retail Merchandising Specialist where you will play a pivotal role in enhancing the shopping experience. In this position, you will be responsible for implementing visual merchandising strategies, ensuring product displays are engaging and effective, and collaborating with store management to drive sales. Your keen eye for detail and creativity will help elevate our brand presence in retail locations.
