Quality assurance manager jobs in Haverhill, MA - 726 jobs

Schedule: Mon-Fri (4 days in office required, 1 day optional remote) Compensation: Competitive Salary + Benefits We are a fast-growing AI language technology company seeking a US/LATAM Spanish Linguistic Quality Lead (LQL) to join our AI-focused language team on a mission to build the next generation of operational models. This is a unique opportunity for someone passionate about languages and technology, with the drive to shape the future of AI-powered communication in medical and life sciences translation. What You'll Do Lead linguistic quality assurance for US/LATAM Spanish, with a strong focus on medical device manuals, pharmaceutical content, and other regulated life sciences materials. Train large language models (LLMs) with Spanish linguistic data to enhance AI-driven translation, QA, and automation workflows. Translate, review, and edit Spanish content in active projects, ensuring accuracy, clarity, and regulatory compliance. Recruit, onboard, and manage Spanish linguistic resources (translators, editors, interpreters, interviewers) within our global network. Support project execution, ensuring linguistic excellence and cultural relevance across deliverables. Collaborate with other LQLs to drive workflow improvements and innovation, helping design future operational models. Partner with cross-functional teams at the intersection of language, life sciences, and AI. What We're Looking For Native proficiency in US/LATAM Spanish, with strong command of English. Ideal for your graduates with Spanish linguistic background. Familiarity with CAT tools (e.g., Phrase, Trados, MemoQ, XTM) is a plus but not required. Forward-thinking, creative, and energetic, with a willingness to take on challenges and think outside the box. Diligent, dependable, and committed to quality and continuous improvement. Strong organizational, communication, and problem-solving skills. Ability to work collaboratively with other LQLs, engineers, and project teams in a fast-paced, innovative environment. Work authorization in the U.S. is required. What We Offer Full-time role: Monday-Friday, with 4 days in-office and 1 day optional remote. Competitive salary + paid holidays, sick/personal days, and professional development opportunities. A modern office in Boston's Financial District. The chance to contribute to an AI-driven language team pioneering future business and operational models. A dynamic, entrepreneurial environment where your ideas and contributions have direct impact. This is an exciting role for someone passionate about Spanish language and culture, eager to explore AI-powered translation and linguistic innovation, and motivated to grow with a company shaping the future of language operations in medical and life sciences. How to Apply: Please send your CV to **********************

A global biotechnology company is seeking a Director of R&D Quality Governance & Risk Management to lead and enhance the governance framework supporting risk-based decisions. This strategic role requires 10+ years of R&D QA experience, strong leadership presence, and operational agility. Candidates should possess exceptional collaboration skills and mentorship capabilities. The role offers flexibility in a hybrid work environment with competitive compensation and comprehensive benefits. #J-18808-Ljbffr

Title: Quality Systems & Investigations Specialist Employment Type: Contract Status: Accepting Candidates About the role This position plays a key role in supporting daily manufacturing activities by resolving operational issues and driving high-quality investigations. The role ensures process reliability through strong technical oversight and collaboration with critical operations teams. Key Responsibilities • Lead real-time floor support, triaging deviations and initiating root cause investigations. • Produce thorough, compliant quality documentation for deviations, CAPAs, and impact assessments. • Partner with manufacturing, QC, facilities, and materials teams to define corrective and preventive actions. • Apply structured scientific thinking to evaluate data and support operational decisions. • Contribute to process improvement by identifying trends and proposing optimized workflows. Qualifications • 6+ years experience in pharma/biotech manufacturing environments. • Proven background in investigations, RCA, QC analytics, and GxP documentation. • Skilled in cross-functional coordination and rapid issue assessment. • Strong analytical mindset with the ability to interpret complex data sets. • Experience supporting manufacturing operations in fast-paced, regulated environments. Compensation (MA Pay Transparency): • Estimated hourly range: $50-$58/hr (W-2). • Final rate within this range will be based on skills, experience, and interview results.

Pay Rate: $40-$50/hr Work Model: Hybrid (Onsite Tuesday, Wednesday, Thursday) The Quality Systems Specialist, under the direction of the QS&C management team, supports global Quality Systems to ensure compliance, operational effectiveness, and fitness for intended use in alignment with applicable global SOPs. Key Areas of Accountability Quality System Governance & Support Assist in governance of Quality System applications, including harmonizing processes across sites Participate in meetings/workshops with Site Process Owners and business SMEs to gather requirements for system improvements and ongoing maintenance Join user forums to collect ongoing requirements, prioritize needs, and triage issues Follow up on requests, issues, and project activities; provide status updates to managers and working teams Change Control & Compliance Initiate and manage change controls through completion, including all required documentation Ensure systems remain in a validated state by supporting periodic user access reviews, change management, business administration, and deviations/CAPAs Support investigation, escalation, and resolution of system-related issues Validation & Documentation Support validation activities, including: Requirements gathering Validation planning Design qualification Authoring and executing test plans and test scripts Discrepancy management Preparing system descriptions and validation summary reports Maintain user-related documentation and ensure updates as new functionalities are introduced Cross-Functional & User Support Assist manager with communication between vendor/IT teams Provide customer support through system administration, training management, and onboarding of new users Generate metrics to support Quality Systems performance Support regular system updates/releases and provide assessments and recommendations on new features Academic & Technical Qualifications Bachelor's degree or higher in a relevant computer, technical, quality, or scientific discipline (multi‑disciplinary background preferred) 3-6 years of experience in a high‑volume commercial or clinical pharma/healthcare environment Proficiency in MS Word, Excel, and Quality System processes Experience with Veeva Vault Quality Docs, TrackWise, and ComplianceWire is a plus Strong understanding of US FDA and European regulatory requirements, GAMP, and phase‑appropriate compliance expectations Knowledge of Regulatory Compliance and ICH Guidelines General Comments Position Title: Quality Systems Specialist Pay Rate Range: $40-$50/hr

A leading biotechnology company in Boston is looking for a Principal Engineer to lead automation of the data QC and reporting processes. The ideal candidate will have extensive experience in technical leadership, particularly in the biotechnology sector, with advanced programming skills in R and Python. Responsibilities include developing modernization initiatives and leveraging AI solutions to improve data management and reporting standards. This position allows for a hybrid work model, requiring up to 10% travel. #J-18808-Ljbffr

Aerospace & Defense Quality Engineer - 6-Month Contract The Quality Engineer will be responsible for the development, implementation, maintenance, and continuous improvement of quality assurance processes in a regulated aerospace and defense environment. This role requires a strong data-driven mindset and hands-on quality engineering expertise to ensure compliance with AS9100/ISO standards, customer requirements, and regulatory obligations. Responsibilities Identify, analyze, and resolve quality issues using structured problem-solving methodologies Perform loss reporting and drive continuous improvement initiatives Design and implement process control, process improvement, testing, and inspection methods Develop, execute, and analyze quality metrics and reporting to support data-driven decision-making Perform and review First Article Inspections (FAI) in accordance with AS9102 requirements Interpret and apply GD&T per ASME Y14.5 to support inspection planning, nonconformance resolution, and root cause analysis Ensure compliance with AS9100 and applicable ISO standards across manufacturing and inspection processes Support and participate in internal, customer, and third-party quality audits Collaborate cross-functionally with engineering, manufacturing, and supply chain teams to ensure quality requirements are met throughout the product lifecycle Qualifications Bachelor's degree in Mechanical, Electrical, Manufacturing Engineering, or a related field (or equivalent experience) 4+ years of quality engineering experience in aerospace, defense, or another regulated manufacturing environment Strong working knowledge of AS9100, ISO 9001, and aerospace quality system requirements Experience performing and reviewing First Article Inspections (AS9102) Proficiency in interpreting engineering drawings and GD&T per ASME Y14.5 Strong knowledge of industry quality tools (e.g., SPC, FMEA, root cause analysis, CAPA) Demonstrated analytical, data-driven approach to problem solving Strong communication, documentation, and audit-support skills To learn more or apply, please contact me at ****************************. BioTalent Ltd is acting as an employment agency in relation to this opportunity.

Job Title: Food Safety Quality Assurance Coordinator Salary Range: $18.00 - 25.00 per hour About us LSG Sky Chefs is one of the world's largest airline catering and hospitality providers, known for its outstanding reputation and dynamic approach in the industry. Voted "Airline Caterer of the Year in North America" for 2023 and 2024, we are committed to excellence and innovation, driven by the dedication and expertise of our talented employees. Our team members are the heart and soul of our success, consistently delivering exceptional culinary experiences and outstanding service to our clients and their passengers across North and Latin America. Role Purpose Statement Primary responsibility is to maintain the "Global Quality System" of LSG Sky Chefs to ensure the Customer Service Center (CSC) is in compliance with customer, Federal Drug Administration (FDA), US Department of Agriculture (USDA), and Seafood Hazard Analysis and Critical Control Points (HACCP) plans including USDA and FDA regulatory standards. Main Accountabilities Maintain and initiate all recordkeeping and key performance indicators pertinent to the Quality Department and GQS to include, but not limited to Food Safety, Sanitation, Regulatory Agencies (County Health, State Health Dept. and FDA), internal customers and airline customers Daily monitor of Good Manufacturing Practices (GMPs) for compliance Verify of coolers and freezer room temperature for compliance Perform environmental swabs and microbiological sampling, submittal to local laboratory for analysis Obtain Chef Table samples to verify compliance to specification Assist the Quality Manager in specific training and daily initiatives addressing quality, food safety, and sanitation issues to drive process improvements Conduct work station inspections to verify compliance (gold standard verification, specs, sanitizer, food temperatures, HACCP documentation, phf set-up) Conduct portion control weight compliance to specifications Conduct inspection checks (dispatch, galley, non-bonded, bonded, equipment) Verify Hazard Analysis and Critical Control Points (HACCP) logs and other documents are accurately completed on a daily basis Create charts, trending reports, training materials and visuals Maintain, monitor standards and train employees in compliance to the Regulated Garbage Standards to meet USDA requirements Supports the Jump-off (commissary) locations with oversight Train hourly employees as needed Perform other tasks as requested Knowledge, Skills and Experience High School Diploma or equivalent Proficient in using computer and basic software such as Microsoft, create and maintain trending charts, SOP's, use of calculator, weight scales, and thermometers, metal detector, ATP testing equipment, mechanical food portioning and processing equipment. Previous food industry and quality assurance experience a plus Ability to work in cold environment ( Ability to work with minimum to no supervision, act in liaison of the Supervisor, self-starter, and problem solver. Ability to lift/push a minimum of 25 lbs. Strong mathematical, analytical, verbal, written, interpersonal and organizational skills Ability to work in fast paced environment with large groups Must be flexible to work weekends/holidays LSG Sky Chefs is an EEO and Affirmative Action Employer of Women/Minorities/Veterans/Individuals with Disabilities.

Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess' patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world. The Role: The Quality Engineer I / II will support Quality Assurance activities for Vaxess' combination product programs, with a strong focus on medical device design controls, risk management, and cGMP compliance. This role provides hands-on quality support across design and development, supplier oversight, process validation readiness, and batch record/data review, aligned with ISO 13485, 21 CFR 820, and applicable combination product regulations (21 CFR 4). Reporting to the Quality Assurance Manager, this role works cross-functionally with Manufacturing, Process Development, Quality Control, and Material Management to support compliant execution and ensure product quality and safety during early clinical development. Responsibilities: Support quality oversight of Vaxess combination product(s) to ensure compliance with safety, efficacy, and regulatory requirements. Administer and support the Quality Management System (QMS) in accordance with ISO 13485, 21 CFR 820, 21 CFR Part 4 (Combination Products), and applicable FDA and international regulations. Provide quality support for Design Control activities, including Design History File (DHF) maintenance, design reviews, Design Verification and Validation (DVV), and design changes. Support risk management activities, including development and maintenance of risk analyses (e.g., FMEA, hazard analyses) and linkage to design and process controls. Support process validation and qualification activities, including test method validation (TMV), process validation (PV), and equipment qualification, as applicable to Phase I and GMP-ready manufacturing. Participate in Material Review Board (MRB) activities, including nonconformance assessment, disposition, and documentation. Perform quality review and approval of batch records, executed manufacturing records, analytical data collection forms, test records, and technical or experimental reports. Collaborate in supplier quality management activities, including supplier qualification, auditing, monitoring, change evaluation, and periodic requalification. Author, review, and revise quality documentation, including SOPs, work instructions, test methods, protocols, reports, forms, and specifications. Support preparation, review, and organization of quality data and documentation for regulatory submissions and inspections. Contribute to continuous improvement initiatives within the QMS, including CAPA, deviation investigations, and quality metrics. Qualifications: Quality Engineer I: Minimum of 3 years of experience in Quality Assurance or Quality Engineering within a cGMP-regulated medical device or combination product environment. Quality Engineer II: Typically 4-5 years of progressive quality experience in medical devices, pharmaceuticals, biologics, or combination products. Working knowledge of ISO 13485 and FDA medical device Quality System Regulations (21 CFR 820); familiarity with combination product requirements strongly preferred. Experience supporting early-phase (preclinical to Phase I) product development is highly desirable. Experience with design controls, risk management (FMEA), and validation activities preferred. Experience reviewing GMP documentation such as batch records, test methods, protocols, and reports. Strong written and verbal communication skills, with the ability to clearly document technical and quality concepts. Proficiency with Microsoft Office applications (Word, Excel, PowerPoint). At Vaxess, we're bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. To apply, please submit your CV/resume to ****************** .

About Analog Devices Analog Devices, Inc. (NASDAQ: ADI ) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably connect humans and the world. With revenue of more than $9 billion in FY24 and approximately 24,000 people globally, ADI ensures today's innovators stay Ahead of What's Possible. Learn more at ************** and on LinkedIn and Twitter (X). Job Description: Quality and Regulatory Manager Job Title: RA/QA Manager Location: US-based , Wilmington, MA (remote will be considered) Function: Regulatory and Quality Reports to: Business Lead Analog Devices, Inc. (NASDAQ: ADI ) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably connect humans and the world. With revenue of more than $9 billion in FY24 and approximately 24,000 people globally, ADI ensures today's innovators stay Ahead of What's Possible. Learn more at ************** and on LinkedIn and Twitter (X). You will be working within a small, stealth group of talented individuals at ADI focused on next-generation technologies solving some of the world's toughest problems around human and planetary health. We are seeking an experienced and highly motivated Quality and Regulatory Manager to lead the development, implementation, and maintenance of our Quality Management System (QMS) and oversee regulatory submissions for medical devices and life science products. The ideal candidate will have proven expertise in U.S. FDA regulatory submissions, including successful 510(k) approvals, and will ensure compliance with applicable domestic and international regulations. Key Responsibilities * Develop, implement, and maintain a comprehensive Quality Management System (QMS) aligned with ISO 13485, FDA QSR, and other applicable regulations. * Lead the preparation, submission, and maintenance of regulatory submissions including FDA 510(k), CE Mark Technical Files, and international registrations. * Ensure company-wide compliance with all relevant quality and regulatory standards. * Manage internal and external audits, inspections, and corrective/preventive actions (CAPA). * Provide regulatory strategy and guidance to cross-functional teams during product development and commercialization. * Establish and maintain policies, procedures, and training programs to support quality and regulatory compliance. * Monitor changes in global regulatory requirements and advise management on their potential impact. * Serve as the primary liaison with regulatory agencies and notified bodies. * Lead risk management activities and ensure compliance with ISO 14971 requirements. * Support post-market surveillance activities, including complaint handling and adverse event reporting. Qualifications and Experience * Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, or related field (Master's preferred). * Minimum of 10 years of progressive experience in quality and regulatory roles within the medical device or life sciences industry. * Proven track record of successful FDA 510(k) submissions and approvals. * Strong knowledge of ISO 13485, FDA QSR, ISO 14971, MDR, and other relevant regulatory frameworks. * Experience managing QMS development, implementation, and continuous improvement. * Demonstrated ability to interface effectively with regulatory bodies, auditors, and internal teams. * Excellent organizational, leadership, and communication skills. * Ability to work independently and collaboratively in a fast-paced environment. For positions requiring access to technical data, Analog Devices, Inc. may have to obtain export licensing approval from the U.S. Department of Commerce - Bureau of Industry and Security and/or the U.S. Department of State - Directorate of Defense Trade Controls. As such, applicants for this position - except US Citizens, US Permanent Residents, and protected individuals as defined by 8 U.S.C. 1324b(a)(3) - may have to go through an export licensing review process. Analog Devices is an equal opportunity employer. We foster a culture where everyone has an opportunity to succeed regardless of their race, color, religion, age, ancestry, national origin, social or ethnic origin, sex, sexual orientation, gender, gender identity, gender expression, marital status, pregnancy, parental status, disability, medical condition, genetic information, military or veteran status, union membership, and political affiliation, or any other legally protected group. EEO is the Law: Notice of Applicant Rights Under the Law. Job Req Type: Experienced Required Travel: Yes, 10% of the time Shift Type: 1st Shift/Days The expected wage range for a new hire into this position is $106,500 to $159,750. * Actual wage offered may vary depending on work location, experience, education, training, external market data, internal pay equity, or other bona fide factors. * This position qualifies for a discretionary performance-based bonus which is based on personal and company factors. * This position includes medical, vision and dental coverage, 401k, paid vacation, holidays, and sick time, and other benefits.

WHOOP is an advanced health and fitness wearable on a mission to unlock human performance and healthspan. We empower our members to improve their health and perform at a higher level through a deeper understanding of their bodies and daily lives. As the Director of Regulatory Affairs & Quality Assurance (RA/QA), you will lead the strategy, execution, and continuous evolution of WHOOP's regulatory and quality frameworks as we expand deeper into regulated digital health and medical-grade product capabilities. You will also play a critical role in strengthening WHOOP's design quality discipline, ensuring robust design controls, risk management, and design quality practices. You will shape the regulatory pathway for our next generation of health features, ensure compliance across global markets, and build systems that enable WHOOP to scale medical device development responsibly and efficiently. This role is ideal for a seasoned RA/QA leader who thrives in fast-paced, cross-functional environments and is motivated by the opportunity to help define the future of WHOOP as a health technology company.QUALIFICATIONS: Lead regulatory strategy for WHOOP's health features and regulated products from development through approval and lifecycle management. Oversee regulatory submissions including 510(k), De Novo, technical files, global registrations, providing strategic direction, final review, and cross-functional alignment. Serve as WHOOP's primary liaison with regulatory agencies and notified bodies. Interpret and communicate regulatory requirements to cross-functional teams, ensuring seamless integration throughout the development lifecycle. Oversee WHOOP's Quality Management System (QMS) to ensure compliance with FDA, ISO 13485, MDR, and other global regulatory frameworks. Provide leadership and oversight for Design Quality Engineers responsible for DHF maintenance, design reviews, risk management (ISO 14971), verification/validation strategy, and software change control processes. Lead internal and external audit readiness, including FDA inspections and notified body audits. Manage post-market surveillance and adverse event reporting. Review marketing and promotional materials for regulated and general wellness features to ensure compliance. Build, manage, and mentor a high-performing team. Monitor regulatory changes, evolving standards, and industry trends, advising leadership on implications and opportunities. RESPONSIBILITIES: Bachelor's degree in life sciences, engineering, regulatory affairs, or a related field; advanced degree preferred. 8+ years of regulatory affairs experience in medical devices, digital health, wearables, or related fields. Proven experience leading successful FDA submissions (510(k), De Novo) and managing global regulatory approvals. Demonstrated success building or overseeing a Quality Management System, including experience with external audits. Deep understanding of software as a medical device (SaMD), cybersecurity considerations, post-market requirements, and applicable standards. Strong working knowledge of ISO 14971 risk management, including hazard analysis, FMEAs, risk/benefit justification, and integration of risk controls across hardware, firmware, and software. Experience overseeing post-market quality activities, including complaints, MDR/Vigilance assessments, field actions, and design updates based on post-market signals. Working knowledge of privacy and data regulations such as HIPAA and GDPR. Exceptional communication, leadership, and stakeholder management skills. Ability to thrive in a fast-paced, high-growth environment with evolving priorities. Experience navigating the boundary between general wellness and SaMD, including evaluating feature intent, regulatory risk, and appropriate evidence pathways. It is strongly preferred that the candidate is able to work out of the WHOOP office located in Boston, MA. Interested in the role, but don't meet every qualification? We encourage you to still apply! At WHOOP, we believe there is much more to a candidate than what is written on paper, and we value character as much as experience. As we continue to build a diverse and inclusive environment, we encourage anyone who is interested in this role to apply. WHOOP is an Equal Opportunity Employer and participates in E-verify to determine employment eligibility. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. The WHOOP compensation philosophy is designed to attract, motivate, and retain exceptional talent by offering competitive base salaries, meaningful equity, and consistent pay practices that reflect our mission and core values. At WHOOP, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of WHOOP and share in the company's long-term growth and success. The U.S. base salary range for this full-time position is $220,000-$245,000. Salary ranges are determined by role, level, and location. Within each range, individual pay is based on factors such as job-related skills, experience, performance, and relevant education or training. In addition to the base salary, the successful candidate will also receive benefits and a generous equity package. These ranges may be modified in the future to reflect evolving market conditions and organizational needs. While most offers will typically fall toward the starting point of the range, total compensation will depend on the candidate's specific qualifications, expertise, and alignment with the role's requirements. Learn more about WHOOP .

About the role Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who are passionate about delivering the possible to patients, and who lead with the desire to work on novel ideas. As a Director of External Quality Assurance, you will report to Head of Technical Quality to provide Quality oversight on manufacturing operations at Contract and Development Manufacturing Organizations (CDMOs). The scope of work will include Sana's programs from pre-clinical, clinical and subsequently commercial operations serving the US and ex-US regions. The role will include performing Quality person in the plant (PIP) activities at CDMOs for critical operations. This role will also require supporting external audits of Sana's suppliers and contract services. Approximately 30% travel may be required. What you'll do * Provide leadership and quality oversight for operations at Sana CDMOs, which may require onsite support at the CDMO. * Represent Quality at internal and external project team meetings and build relationships with Quality counterparts at CDMOs and CTLs. * Perform batch review and ensure timely and accurate batch disposition of materials and/or Sana products. * Partner with technical departments to help ensure success of technical transfer activities from Sana to the CDMO partners. * Partner with CDMO to identify and address gaps or areas for improvement in systems, procedures, and quality initiatives. * Collaborate with other functions in CDMO Manufacturing, QC, and Process Development teams to evaluate, investigate and resolve issues. * Responsible for batch release of Sana products manufactured at CDMOs. * Understand the Quality Management System and influence phase-appropriate SOPs, change control, investigations, CAPA, compliance, document management, training management and validation. * Establish and maintain Quality Technical Agreements and ensure alignment with other legal contracts as needed with CDMOs and CTLs. * Maintain a Quality Risk Management system to identify and mitigate compliance risks. * Ensure that CDMO facilities, utilities, and equipment are maintained in a validated or qualified state. * Support qualification activities for suppliers, contract testing laboratories, contract manufacturing organizations and contract services. * Perform supplier audits in accordance with Sana requirements. * Support the complaint program; review and approve the complaint reports to ensure all quality complaints are thoroughly investigated and ensure the CAPA plans for the resolution of the complaints are developed and executed. * Serve as the Sana business process owner for Quality batch disposition activities. * Support inspection and/or audit readiness activities for inspections by Health Authorities, and partners. What we're looking for * Self motivated leader who can influence others and exercise sound judgement when managing issues during critical operations. * Experience in working with CDMOs in various product lifecycle stages. * Operational experience in manufacturing aseptic environments, in quality or manufacturing. * Experience in leading and managing complex investigations. * Experience in batch disposition activities. * Familiar with the US, EMA, and ICH regulations and guidance documents * Effective communicator where you can articulate concerns and/or issues in a clear and concise manner. * Demonstrated ability to engage team members across diverse teams. * Ability to effectively prioritize and deliver high-quality results on tight timelines. * Demonstrated ability to independently problem solve including the ability to devise and implement practical solutions to resolve QA issues while being mindful of impact to timelines, resources and conflicting priorities. * Experience in inspection readiness activities, presenting during inspections and/or hosting Health Authority inspections. * Bachelors or Masters plus 10-12 years of work experience. What will separate you from the crowd * Cell and Gene Therapy product experience preferred * Experience in expedited release processes What you should know * Approximately 30% travel may be required. * The role will be based at the Sana Cambridge, MA location and will require onsite presence. * The base pay range for this position at commencement of employment is expected to be between $200,000 - $250,000 annually; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience How we work together for patients * Lead from every seat - we seek to understand, act with honesty, and engage in the crucial conversations * Thrive as a team - we hire amazing people, are intensely curious, and cultivate inclusion and personal connectivity * Make it happen - we value vigorous debate, alignment around our decisions, and resilient execution Get to know us At Sana, we believe that a workforce with varied backgrounds strengthens us as a company and helps us to achieve our mission to meaningfully change the outcome of many human diseases. This belief is a pillar of our business and is critical to our success. Our goal is that Sana is the place for talented people to bring their authentic selves to work, to have a great career and to deeply, positively impact patients. Core to our values, we believe there is nothing more important than the health and wellness of you and your family. For benefit eligible employees, we cover a generous portion of the cost for employee health coverage, making high-quality care more accessible and affordable. We offer ample time-off (various paid time off benefits, such as holidays, vacation, sick time, and parental leave), short- and long-term disability, employer paid basic life insurance, additional voluntary life insurance protection, financial wellness programs including financial planning resources, a 401(k) Plan with an immediately vested employer match, Tuition Reimbursement and Student Loan Repayment, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually. For more details on our benefits, visit Sana's Benefits Portal. We are committed to providing a workplace free of discrimination and harassment based on race, color, religion, age, gender, national origin, ancestry, physical or mental or sensory disability (including the use of a trained guide dog or service animal by a person with a disability), genetic information, actual or perceived HIV or Hepatitis C infection, medical condition (cancer or a record or history of cancer and genetic characteristics), marital status, sexual orientation, sexual preference, pregnancy (including childbirth and related medical conditions), disability, veteran status, political ideology, social class (including caste/caste identity), taking or requesting statutorily protected leave, status as a victim of domestic violence, sexual assault or stalking, or any other basis prohibited by applicable law. To perform this job successfully, you must be able to perform each job responsibility satisfactorily. The job description listed above is representative of the knowledge, skills, and/or abilities required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions described above.

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more ************************* and follow us on X, LinkedIn and Facebook. Role Summary: The Director of QA GMP Operations is responsible for management of GMP quality within our external manufacturing operations globally and internal GMP operations for development and commercial programs. The Director will also work closely with internal business stakeholders as well as internal Quality function to deliver outcomes to advance programs within compliance. The Director is responsible for oversight of QA activities and ensuring the quality of deliverables within the role's purview. This is an onsite role based in Waltham, MA. Primary Responsibilities Include: * Management of external quality operations in support of GMP manufacturing (clinical and commercial) activities. * Manage deviations, OOS and OOTs investigations while adhering to cGMP principles and ICH guidelines. * Review batch records, analytical method reports and technical reports including regulatory sections of IND/IMPD and BLA/MAAs. * QA support of Tech Transfer and Process Validation activities. * Disposition of GMP batches and interfacing with the Qualified Person (QP). * Change management to ensure proper evaluation of manufacturing and testing related changes by Quality, Regulatory, and Subject Matter Experts. * Manage CDMO performance within Quality Agreement expectations and GMP compliance. * Drive continuous improvement and inspection readiness. * Collaborate cross functionally to ensure pre-approval inspection and commercial readiness activities are completed at the CDMOs and internally. * Adjudicate on compliance discussions and negotiate any required corrective actions. * Create and foster a culture of collaboration and engagement for advancing quality outcomes and operational excellence. Education and Skills Requirements: * Minimum of a BA/BS degree * Minimum of 10+ years of experience in GMP Quality Operations in a clinical late stage and/or commercial biotechnology company * Leadership experience managing cross-functional teams with an ability to influence teams to prioritize activities and allocate resources without direct authority * Experience implementing and utilizing various outsourcing and support models * Experience with disposition of product batches and interfacing with a Qualified Person (QP) * Excellent written and oral communication skills, including well-developed presentation skills * Excellent organizational skills and ability to manage multiple priorities * Strong collaboration and interpersonal skills to effectively interact with internal or external stakeholders at all levels in the organization * General business management knowledge to assess the impact of project decisions on financial and corporate objectives * Ability to drive timelines, meet firm deadlines, and adapt quickly to changing requirements and priorities * Embrace Dyne's core values and culture #LI-Onsite MA Pay Range $188,000-$230,000 USD The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

InnoTECH Staffing is looking to hire a fulltime permanent Director of Regulatory Affairs & Quality Assurance (RA/QA) for an exciting and growing medical device company in Burlington, MA. Candidate must be local and be able to go to office a few days a week. Must be a US Citizen or Greencard Holder! Our client is a medical device manufacturer committed to advancing cancer therapy through research, engineering, high-quality products, and exceptional physician support. We are seeking a Director of RA/QA to lead all regulatory affairs and quality assurance activities for the company as they continue to expand their global presence and product portfolio. 90% of this role is internal and external audits, dealing with findings, CAPAs, updating procedures, returns, non conformities. 10% new submissions / regulatory approval in countries outside the US. Job Description · Lead, manage, and develop the Regulatory Affairs and Quality Assurance functions to ensure organizational compliance with global medical device regulations and standards. · Oversee the development, implementation, and continuous improvement of the company's Quality Management System (QMS) in accordance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory frameworks. · Direct internal GMP/QSR audits and manage external audits from regulatory agencies, notified bodies, and key customers. · Lead the preparation, submission, and maintenance of device regulatory submissions including EU MDR Technical Documentation, 510(k) applications, FDA listing/registration, and international market authorizations. · Oversee and ensure compliance with complaint handling, medical device reporting (MDR/Vigilance), field corrections/recalls, and import/export regulatory requirements. · Direct the creation, execution, and maintenance of internal and supplier quality audits; ensure suppliers meet regulatory and company quality expectations. · Oversee product and process validation programs, including IQ/OQ/PQ activities, ensuring that products are consistently manufactured to specifications and compliant with regulatory expectations. · Provide strategic regulatory input for new product development, design changes, and lifecycle management activities. · Serve as the primary liaison with regulatory authorities, notified bodies, and external partners regarding regulatory and quality matters. · Lead RA/QA daily operations including CAPA management, risk management activities (ISO 14971), document control, training, and quality metrics reporting. · Advise executive leadership on regulatory strategy, quality trends, risk factors, and compliance status to support business objectives. Education / Experience Requirements · Bachelor's degree in a scientific or engineering discipline; advanced degree preferred. · 8+ years of experience in FDA and EU medical device Regulatory Affairs and Quality Assurance, with demonstrated expertise in global regulatory requirements and quality system standards. · Minimum of 5 years of medical device quality assurance experience with strong working knowledge of ISO 13485 and FDA QSR. · Experience in preparing and managing regulatory submissions (e.g., 510(k), EU MDR) and supporting regulatory audits/inspections. · Excellent organizational, leadership, interpersonal, and communication skills. · Demonstrated success in a hands-on, fast-paced, cross-functional medical device environment. Specialized Skills / Other Requirements · Strong understanding of risk/benefit analysis, product safety principles, and regulatory science applicable to interventional medical devices. · Proven ability to effectively manage multiple complex projects and enforce timelines in a growing organization. · Strong technical writing skills and the ability to create clear, compliant regulatory and quality documentation. · Ability to collaborate across departments including R&D, Manufacturing, Operations, Clinical, and Marketing. · 10% to 25% travel may be required for audits, regulatory meetings, and supplier visits. · Self-starter with excellent attention to detail and the ability to follow through on commitments. Full-time position with competitive compensation, medical/dental insurance, 401(k), and professional development opportunities.

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US, EU Directives, US FDA, PMDA, ICH). Essential Functions * Independently conduct audits * Review and oversee results of CQA audits of study sites, clinical vendors, clinical documents, and internal process audits * Facilitate Sponsor health authority inspections of global clinical facilities and study sites * Continuously drive innovation through active search, evaluation, acquisition, and implementation of high-impact new technologies/ procedures across clinical quality programs * Direct skill-building interventions for CQA staff through cross-functional/ external partnerships to reskill/ upskill and adapt the workforce to evolving technologies. * May be responsible for direct people management including goal setting, performance management, development, and engagement. Requirements * Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related area. * 5+ years of experience in GCP auditing. * Substantial experience in inspection management. * Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of clinical trials. * Demonstrated ability to operate and influence decision-making processes * Effective communication skills * Successful track record of supervising employees and managing cross-cultural differences * Technical and administrative capabilities to independently carry out routine, complex and for-cause audits * Knowledge of data integrity controls and systems quality for clinical area * Strong analytical skills and report writing skills * Experience with GxP systems including computer system validation and associated regulations, recommended. * Ability to Travel (approximately 20%) * Candidates near Eisai's NJ/PA location will be preferred. For candidates near an Eisai location, Remote Work Arrangement will consist of 2-4 days in office (Nutley/Exton) per month and 1-2 audits quarterly; remote audits, are held in Nutley. CQA is also expected to be present in Nutley for any inspections or critical inspection mgmt. activities. Eisai Salary Transparency Language: The base salary range for the Director, Clinical Quality Assurance is from :195,000-256,000 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit *********************************************** Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation

We are looking for an experienced Construction Quality Control Manager to join our team. This role is responsible for developing, implementing, and managing quality control systems to ensure that construction activities and outputs comply with project specifications, company standards, and regulatory requirements. This role is critical in ensuring the delivery of high-quality of DEW Construction's projects through oversight, inspection, and coordination with project teams, subcontractors, and third-party inspectors. DEW's Vision, Mission, and Core Values: Vision Statement: To be the go-to construction partner known for our unwavering commitment to the success of every project. Mission Statement: To build a team of professionals who share our core values and foster a culture where everyone can thrive and grow together. Core Values: Optimism: We share a positive mindset, believing in opportunities over obstacles. Initiative: We are self-motivated, proactive problem solvers. Accountability: We are committed to a culture of ownership, personal accountability, and safety. DEW's Vision, Mission, and Core Values are explicitly integrated into our daily decision-making, leadership behaviors, employee training, performance evaluations, and company culture. We use them as a guiding principle for all activities and hold employees accountable for upholding them, essentially making them a tangible part of the company's identity and operations. Our aim is to ensure we are aware of these guiding principles and feel motivated and encouraged to continue integrating them into our daily lives Essential Functions: Quality Assurance Program Development: Develop and maintain project-specific Quality Control Plans (QCPs). Ensure construction compliance with applicable project documents (Plans, Specifications, submittals, standards, regulations, and customer requirements. Lead quality meetings and contribute to project pre-construction planning efforts. Inspection and Testing: Oversight and documentation of inspections, materials, workmanship, and final products. Coordinate and document third-party testing and special inspections. Identify and correct deficiencies with the project team utilizing Procore Observations to document deficiencies and non-compliant work as well as corrective action plans. Documentation and Reporting: Maintain detailed and organized quality records, including inspection logs, test reports, and compliance certifications. Prepare and submit daily quality reports and project QA/QC status updates. Review and approve subcontractor and supplier quality documentation. Team Leadership and Communication: Serve as the primary point of contact for quality control matters on the job sites for the Project Teams. Train and mentor construction staff and subcontractors on quality standards and procedures. Facilitate communication between project management, clients, regulatory agencies, and contractors. Prepare monthly QAQC Reports to identify areas of concern, compliance, recommendations to improve performance. Continuous Improvement: Analyze quality trends and data to identify opportunities for process improvement. Recommend and implement best practices to enhance overall construction quality. Essential Experience: Education: Bachelor's degree in Civil, Mechanical, or Structural Engineering, Construction Management, or related field preferred. Equivalent experience may be considered. Experience: Minimum 5-7 years of experience in construction quality control, preferably in commercial, industrial, or federal/military projects or requisite field experience. Prior experience with government contracts (e.g., USACE/NAVFAC) is a plus. Certifications (Preferred): USACE Construction Quality Management (CQM) Certification OSHA 30-Hour Certification ACI, ICC, or other relevant technical certifications Skills & Abilities: Strong knowledge of construction methods, materials, standards, and regulations. Excellent attention to detail, organizational, and analytical skills. Proficient in reading and interpreting blueprints and specifications. Strong written and verbal communication skills. Proficiency with MS Office and construction management software (Procore, Primavera, Bluebeam). If you are interested in being part of an innovative and collaborative team, in a challenging and rewarding work environment, we want to hear from you! We are always trying to stay a step ahead of emerging trends in the industry. Every employee is part of the process and part of our success. DEW's philosophy is to invest in people and inspire them to bring the best of themselves to work every day. In addition to offering competitive wages and a comprehensive benefits package, employees are given opportunities to learn, develop and grow. These are the reasons DEW is named amongst the top places to work in New Hampshire and Vermont. We are an Equal Opportunity Employer.

ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers . If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post. Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Key Responsibilities: Subject Matter Expert (SME) and / or Local Process Owner (LPO) for Vendor Qualification and Management. Manage lifecycle activities of qualification and routine oversight of GMP and GDP vendors. This includes assessing new vendors, developing and revising Quality Agreements, providing input to the vendor risk assessment and audit program, and maintaining accurate data within the Approved Vendor List in the electronic Supplier Quality Management system. Subject Matter Expert and / or Local Process Owner for Material Qualification and Management. Manage the lifecycle activities of materials used for the manufacture of drug substance, which involves material qualification, maintenance / control, reduced testing, and direct dispensing. Conduct timely impact assessment of supplier change notifications and ensure actions are prioritized and driven to completion utilizing the change management system to ensure business continuity. Facilitate nonconformance reporting and resolution via Supplier Corrective Action Request (SCAR), deviation, and Corrective and Preventive Actions (CAPA) as appropriate related to materials or services provided by vendors. Manage the process for quality oversight of on-site service vendors, collaborating closely with cross-functional partners that frequently engage these service vendors, such as Facilities & Engineering. As LPO or SME maintain site readiness for regulatory inspections and interact with inspectors in response to requests as required. Collaborate within the Supplier QA team, cross-functionally, and with Global Process Owners to continuously improve processes, innovate, and contribute to predictive compliance. Support external audits as needed. Perform quality review and approval of functional area documents including Standard Operation Procedures, technical documents, risk assessments, reports, agreements, and qualifications. Coordinate and lead meetings with site stakeholders, other network sites, and external partners concerning vendor and material management programs, including discussions, negotiations, and dispute resolution. Additional Qualifications/Responsibilities Qualifications & Experience: Knowledge obtained through formal education resulting in a Bachelor of Science (B.S.) degree in a field such as science, engineering, biochemistry, or a related discipline, or a suitable combination of education, experience, and training. A minimum of 6 years of relevant experience within a regulated environment, including at least 4 years concentrated on product quality, is essential. Experience in managing the quality of suppliers providing raw materials, consumables and services for biologics bulk drug substance manufacturing is highly preferred. Comprehensive knowledge of cGMP regulations and guidelines in the US and EU. Familiarity with Quality Risk Management principles. Proficient understanding of electronic Quality Management Systems such as TrackWise or Veeva/Infinity. Prior work experience where attention to detail and personal accountability were crucial to success. Experience collaborating in a team-oriented environment with a diverse group of individuals. Exceptional writing and verbal communication skills are required. #LI-Onsite BMSBL If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Devens - MA - US: $105,330 - $127,638

Site: Mass General Brigham Health Plan Holding Company, Inc. Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Job Summary Responsible for overseeing and improving clinical performance metrics and ensuring compliance with healthcare regulations and accreditation standards. Collaborates with clinical teams to develop strategies for improving patient care outcomes and ensures that clinical operations align with regulatory and quality requirements. Essential Functions -Monitor and analyze clinical performance data to identify areas for improvement in patient care and outcomes. -Ensure compliance with all regulatory, accreditation, and quality standards across clinical operations. -Collaborate with clinical staff to implement performance improvement initiatives and ensure best practices in patient care. -Develop and maintain clinical performance dashboards and reports to track key metrics. -Coordinate with quality, compliance, and risk management teams to ensure alignment with organizational goals. -Provide training and education to clinical teams on performance improvement, regulatory compliance, and accreditation standards. -Conduct audits and assessments of clinical processes to ensure continuous quality improvement. -Work with leadership to set performance goals and develop action plans to achieve them. Qualifications Education Bachelor's Degree required; work experience can be substituted in lieu of a degree License/Certification Massachusetts Registered Nurse (RN) license highly preferred Experience At least 3-5 years of experience in clinical performance management, compliance, or quality improvement required Knowledge, Skills, and Abilities Knowledge of healthcare regulations, accreditation standards (e.g., Joint Commission), and clinical performance metrics. Strong analytical skills with the ability to interpret clinical data and identify improvement opportunities. Excellent communication and collaboration skills to work effectively with clinical teams and leadership. Detail-oriented with a strong understanding of healthcare regulations and accreditation standards. Proficiency in performance management software and tools for tracking clinical outcomes. Ability to lead performance improvement projects and implement evidence-based practices. Additional Job Details (if applicable) Working Conditions This is a remote role that can be done from most US states Remote Type Remote Work Location 399 Revolution Drive Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $78,000.00 - $113,453.60/Annual Grade 7 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: Mass General Brigham Health Plan Holding Company, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

A leading global biotechnology firm in Boston seeks a Principal Engineer to lead the automation of pre-clinical data pipelines and regulatory reporting solutions. This role focuses on driving modernization and standardization initiatives, leveraging AI technologies, and enhancing data consumption practices. Candidates should possess strong programming skills and a degree in a relevant field, with a minimum of five years in technical leadership within the biotechnology industry. The position offers a hybrid work model and a comprehensive benefits package. #J-18808-Ljbffr

Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess' patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world. The Role The Research Associate/Quality Engineer will be responsible for performing mechanical testing of materials and components using instruments such as Mecmesin, Instron, or equivalent force-measurement systems. This role will support tensile, compression, shear, puncture, and force displacement characterization to ensure product performance, robustness, and compliance with internal quality standards. In addition, the individual will contribute to method development, qualification activities, and routine QC release testing to support clinical and commercial manufacturing programs. This is a unique opportunity to be part of an emerging early-phase clinical company bringing innovative technology to the global market. Key Responsibilities Essential duties and responsibilities include the following. Other duties may be assigned. Perform mechanical testing of materials, components, and finished MAP products using Mecmesin, Instron, or comparable systems, including tensile, compression, shear, puncture, and force displacement profiling. Develop, optimize, and maintain mechanical test methods to support product characterization, comparability studies, and design verification/validation activities. Execute routine QC mechanical release testing aligned with cGMP expectations and data integrity standards. Troubleshoot mechanical testing issues, support instrumentation maintenance, and ensure proper calibration and documentation Analyze mechanical test data, prepare technical reports, and document all activities in audit-ready laboratory records. Collaborate cross-functionally with QC, Analytical Development, Process Development, Manufacturing, and Regulatory teams to enable program success. Assist in broader QC testing efforts as needed, including support for analytical, functional, and stability assays. Independently author method SOPs, analytical protocols, technical reports, and contribute to regulatory submissions. Maintain rigorous laboratory documentation and complete, audit-ready analytical records. Collaborate effectively with QC, Manufacturing, Process Development, and Regulatory teams to enable program success across phases. Thrive in a fast-paced, cross-functional environment with excellent communication and organizational skills. Qualifications Bachelor's degree in Mechanical Engineering, Materials Science, Biomedical Engineering, or a related discipline; 1-3 years of relevant mechanical testing or QC experience, or a master's degree with applicable laboratory experience. Hands-on experience with mechanical testing instruments such as Mecmesin, Instron, Texture Analyzer, or equivalent force-measurement systems. Demonstrated proficiency in tensile, compression, shear, puncture, and force-displacement mechanical characterization. Experience developing, optimizing, and/or qualifying mechanical test methods for materials, components, or finished products. Familiarity with GMP, GLP, or ISO 17025 laboratory environments and strong understanding of data integrity (ALCOA+). Ability to analyze mechanical test data, generate clear technical reports, and maintain accurate documentation. Experience supporting QC release testing, method qualification, method transfer, or equipment qualification is a plus. Strong organizational skills with the ability to manage multiple workflows and prioritize effectively in a fast-paced environment. Excellent verbal and written communication skills and comfort working within interdisciplinary teams. Commitment to collaborative work within interdisciplinary project teams. At Vaxess, we're bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. To apply, please submit your CV/resume to ****************** .