Quality Assurance Engineer in Manufacturing

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…

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.

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.

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.

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

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.

Xometry (NASDAQ: XMTR) is at the forefront of transforming manufacturing by bridging innovative ideas with the manufacturers who can actualize them. Our digital marketplace empowers manufacturers with essential resources to scale their operations while providing Fortune 1000 companies seamless access to global manufacturing capacity.We are on the lookout for motivated Mechanical Engineers to serve as Technical Account Managers (TAMs) who will engage directly with our key enterprise accounts. In this pivotal role, you will integrate deeply with our clients' engineering teams, combining customer engagement, technical acumen, and operational execution to drive mutual success. While reporting to the Operations team, you will collaborate closely with Sales to foster growth and enhance customer satisfaction.This is an exceptional opportunity to join a vibrant and expanding organization leading the charge in digital manufacturing. If you are a passionate Mechanical Engineer eager to contribute to customer success and create a tangible impact, we would love to hear from you.

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.

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 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.

Markforged (NYSE: MKFG) is at the forefront of transforming the manufacturing landscape through innovative engineering. Our unique platform integrates advanced software, superior materials—including state-of-the-art metal and composite technologies—and industrial-grade 3D printers to produce robust, functional parts across various industries. We empower our customers to navigate complex supply chains, minimize costs, and enhance innovation by enabling in-house production of high-performance tools, fixtures, prototypes, and end-use components.Renowned for our cost-effective 3D metal and carbon fiber printers, Markforged creates components durable enough for industrial applications. Engineers, designers, and manufacturing professionals globally trust our 3D printers for tooling, fixtures, functional prototyping, and high-value production, optimizing their manufacturing processes. Established in 2013 and headquartered in Watertown, MA, we employ around 300 talented individuals and have attracted $137 million in strategic and venture capital. Recognized by Forbes as one of the Next Billion-Dollar Startups and as the fastest-growing 3D printing company in the US by Deloitte in 2019, Markforged envisions a world where anything you can imagine can be built. Visit us at markforged.com for more information.

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 and processes Help ensure compliance with relevant regulations and industry standards Support ongoing maintenance and documentation of quality procedures

The Transducer Manufacturing Engineering Co-Op at Wabtec Corporation in Waltham provides hands-on experience in both engineering and manufacturing. This role supports the design and production of advanced transducer technologies, working closely with skilled team members. What you will do Assist with the design and manufacturing of transducer products Contribute to ongoing engineering projects Work alongside experienced professionals to gain industry knowledge Learning and development This co-op offers the chance to apply classroom knowledge to real-world engineering challenges. Expect to build practical skills while supporting the team’s daily work and project goals.

At ElevateBio, we are a pioneering technology company at the forefront of advancing the life sciences. We empower our partners to unlock the full potential of their therapies, guiding them from initial design through to successful commercialization. Our unique blend of innovative technologies, comprehensive services, and unparalleled manufacturing expertise enables us to accelerate the development of cutting-edge therapies efficiently and effectively. The Opportunity:We are seeking a talented Manufacturing Execution System (MES) Engineer II to join our dynamic team. Reporting directly to the Associate Director of Operational Technology, you will play a crucial role in supporting and optimizing our Manufacturing Execution System. As an experienced member of the MES team, you will help us enhance our capabilities as a Contract Development and Manufacturing Organization (CDMO). This position may involve some supervisory responsibilities as delegated.Your Responsibilities:Collaborate with the MES team and Manufacturing Operations:Provide expert support to the MES team, ensuring the successful execution of all related activities.Assist Senior MES Engineers with MES initiatives and projects.Identify and implement process improvements for MES team efficiency and effectiveness.Deliver technical support for manufacturing operations, including on-call assistance and troubleshooting MES issues with software vendors.Manage administrative duties for the MES system, including user access, system configurations, and security settings.Mentor junior MES engineers and foster a collaborative, innovative, and respectful work environment.Perform additional duties as assigned.Logbook & Batch Record Templates and Tech Transfer Support:Design, develop, and test templates for Electronic Batch Records (EBRs) and Electronic Logbooks (eLogs).Establish best practices for template design in collaboration with Manufacturing and Science Technology (MSAT), Manufacturing (MFG), and Quality Assurance (QA).Enhance the template design and testing strategy.Assist stakeholders and clients in understanding MES requirements during tech transfer projects, including change management and template development timelines.

At Xometry (NASDAQ: XMTR), we are at the forefront of innovation, connecting visionary thinkers with the manufacturers capable of transforming their ideas into reality. Our digital marketplace empowers manufacturers with essential resources for growth while enabling Fortune 1000 companies to seamlessly access global manufacturing capabilities.We are on the lookout for a Principal Software Engineer to spearhead the technical design and engineering of advanced systems aimed at predicting and resolving challenges in the manufacturing of our clients' parts. Your expertise will combine machine learning model predictions, part geometry data, and customer insights to enhance our ability to forecast manufacturing costs and identify suitable partners for successful part production. While previous experience in manufacturing or machine learning is beneficial, it is not a prerequisite.The successful candidate will bring at least 8 years of industry experience, with a minimum of 4 years in a technical leadership role within a dynamic, collaborative environment. This position requires a blend of technical leadership and hands-on contributions. Our teams thrive on collaboration, cross-functionality, and a rapid pace of innovation.

Join our team at dstaff as a Principal Software Quality Assurance Engineer specializing in mobile applications. In this pivotal role, you will lead the quality assurance efforts, ensuring the delivery of top-notch mobile applications that meet our high standards. You will collaborate closely with development teams to design and implement testing strategies, identify defects, and drive continuous improvement in our software development lifecycle.

Xometry (NASDAQ: XMTR) serves as a catalyst for innovation by connecting visionary thinkers with the manufacturers equipped to transform their ideas into reality. Our cutting-edge digital marketplace empowers manufacturers with essential resources, enabling them to expand their operations while facilitating access for buyers from Fortune 1000 companies to global manufacturing capabilities.We are currently looking for a dynamic and results-oriented Partner Engagement Manager to spearhead our Partner Network initiatives. This role is pivotal in supplier development, concentrating on nurturing and managing a high-caliber network of partners. You will play a key role in enhancing partner competencies, driving outstanding performance, and ensuring alignment with our operational objectives to achieve superior outcomes for our clientele.Your daily responsibilities will involve closely analyzing opportunities to elevate supplier quality by acting as both an advocate and mentor. You will establish yourself as a trusted resource, ultimately aiming to improve customer satisfaction through reduced manufacturing inconsistencies.

Join Xometry as an Application Engineer specializing in Injection Molding, where you will play a pivotal role in designing and optimizing manufacturing processes. You will collaborate with multidisciplinary teams to deliver innovative solutions that meet our clients’ needs.

About Us:Oruka Therapeutics (Nasdaq: ORKA) is at the forefront of developing innovative biologics aimed at revolutionizing the treatment of chronic skin disorders. Our mission is to empower patients suffering from conditions such as plaque psoriasis by providing opportunities for significant disease clearance with minimal dosing frequency, potentially just once or twice a year. Leveraging a unique portfolio of advanced antibodies engineered by Paragon Therapeutics, we target the fundamental mechanisms contributing to plaque psoriasis and other dermatologic and inflammatory conditions. Learn more about our vision at www.orukatx.com.As we expand our core team, we are seeking passionate professionals who aspire to be part of a transformative journey, not just a job. If you are eager to make a positive impact and contribute to a vibrant, inclusive company culture, we want to hear from you.Job Title: Associate Director, Downstream, Manufacturing Sciences and Technology (Biologics)Location: Hybrid – Waltham, MA, with a requirement to be in-office 3 days a week.Position Overview:We are looking for a dynamic and skilled leader in Manufacturing Science and Technology (MSAT) to spearhead downstream late-stage and pivotal optimization, scale-up, and transfer of manufacturing processes. In this role, you will be responsible for process development, troubleshooting production challenges, data analysis, and ensuring adherence to regulatory standards to uphold product quality. The successful candidate will play a critical role in late-stage drug substance manufacturing and process validation activities to support BLA submissions. This position requires adaptability in a fast-paced environment, along with the ability to draft high-quality reports, finalize source documents, and actively participate in regulatory submissions. Join us as a vital member of a growing team dedicated to advancing best-in-class biotherapeutics.

Join Stemxpert1 as a Mobile Tester and be part of a dynamic team dedicated to ensuring top-notch mobile application quality. As a Mobile Tester, you will play a vital role in the software development lifecycle, ensuring that our mobile applications meet the highest standards before they reach our customers. Your meticulous attention to detail will help us deliver exceptional user experiences.