Quality engineer jobs in Exeter, NH

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 Quality System Specialist / Senior Quality System Specialist plays a key role in supporting and enhancing Vaxess Technologies' Quality Management System (QMS) to ensure compliance with applicable GMP/GLP standards. This position focuses on maintaining robust electronic quality systems, managing controlled documentation, and supporting the integration of new processes and applications. Key Responsibilities: Quality System and Computerized System Oversight Support quality oversight for computerized systems, including QMS implementation, configuration, validation, and data migration activities. Assist in launching new or enhanced system functionalities and communicating updates or user guidance to ensure effective adoption. Collaborate with internal stakeholders and system vendors to ensure integrated processes across modules (Document Control, Training, Equipment, and Material Management). Troubleshoot and resolve user issues as needed. Documentation and Record Management Manage the full lifecycle of controlled documents, including creation, revision, review, approval, distribution, and archival within the electronic document management system (EDMS). Ensure that controlled documents, such as SOPs, batch records, and specifications, are accurate, current, and compliant with regulatory and internal requirements. Coordinate document workflows with cross-functional teams to ensure timely completion and alignment with procedural requirements. Author or revise SOPs, forms, and work instructions supporting quality system and GMP operations. Training and Compliance Support Provide training and day-to-day support to employees on document control and system processes. Serve as a subject matter expert (SME) for document control and computerized systems during internal and external audits and inspections. Support tracking and reporting of quality metrics (e.g., training completion, document cycle time, CAPA effectiveness) to drive continual improvement. Qualifications: Bachelor's degree in Life Sciences, Engineering, or a related discipline preferred; equivalent work experience considered. 2-5 years of experience in a GMP, GLP, or GxP-regulated environment (pharmaceutical, biotechnology, or medical device industry). Experience with electronic quality management systems (e.g., Enzyme, Greenlight Guru, Veeva, MasterControl, etc.) is strongly preferred. Familiarity with relevant regulations and standards (21 CFR Parts 210/211/11/820; ISO 9001/13485). Excellent attention to detail, organization, and communication skills; ability to manage multiple priorities in a dynamic environment. Collaborative, proactive, and adaptable work style aligned with a fast-paced, innovation-driven company. Vaxess, a venture-backed life sciences company, is building a team of exceptional people to rapidly advance products on its microneedle array platform. We work closely as a team and thrive in a dynamic, exciting, and engaging work environment. If you're interested in joining the Vaxess team, please submit your CV/resume to ****************** .

🚀 Contract Opportunity - Quality Engineer (Edifecs Project) 📍 Remote (U.S.-based only) | 💼 7-Month Contract | 💰 W2 Only We're looking for experienced Quality Engineers to join a remote Edifecs project within the U.S. healthcare domain. This is a 7-month W2 contract opportunity with a leading healthcare technology team. Key Responsibilities Review business requirements and data mappings related to the HealthRules Payor ecosystem. Perform manual testing, create and execute test cases, and document results. Design or contribute to comprehensive testing plans. Conduct SQL-based validation and data analysis. Collaborate with technical and business teams to ensure data accuracy and functional integrity. (Optional) Contribute to testing automation or agentic testing initiatives. Required Skills & Experience Strong background in U.S. Healthcare systems and processes. Hands-on experience with HealthRules Payor and HealthRules Data Warehouse. Proficiency in SQL for validation and data testing. Demonstrated experience creating and executing manual test cases. Excellent attention to detail, documentation, and communication skills. Must be authorized to work in the U.S. (W2 only) and reside within the United States. Nice to Have Familiarity with Edifecs integration and testing frameworks. Exposure to automation or agentic testing tools. 📩 Interested? Apply today to join a dynamic remote team working on a transformative U.S. healthcare project.

WHO WE ARE Nextphase.ai is a Data Management solution provider focused on Data Operations services for enterprise data in the cloud. We are leading the innovation agenda with our clients by delivering a portfolio of services to help them improve data quality and manage data governance for their cloud data. NextPhase.ai data management services are tailored to achieve our client's business outcomes thus enabling our clients to focus on monetizing their data while we handle data operations. Nextphase.ai provides you with a dynamic and fun work environment and encourages you to use creative thinking to solve client challenges. Position Overview: We are seeking a dynamic, analytical thinking individual to join our Quality team, this is a contract position focusing on Quality Systems, CAPA, Complaint handling, Internal Audit, metric reporting and process improvement initiatives. The ideal candidate will possess a strong background in medical devices or IVD, with a proven track record in managing quality-related activities in a fast-paced dynamic environment. QMS experience is essential. Responsibilities: This position is responsible for, but not limited to, the following: Supports the overall QMS processes for the organization. Responsible for activities required to ensure compliance of Quality Management Systems (QMS), specifically regarding CAPA, complaints and internal/external audits. Additional responsibilities include supporting other QMS functions such as NCMRs, Supplier Controls, Management Review, Risk Review, etc. Execution and coordination of activities associated with CAPA program, including administration and record management, providing quality input to investigations, reporting, as well as metrics and trending Support CAPA Owners in quality-related technical principles, including but not limited to Problem Solving tools and techniques (Root Cause Analysis, DOE, FMEA, etc.) Investigate customer complaints, from intake through investigation and closure Manages the Internal Audit program, including scheduling audits, ensuring timely response to findings, as well as metrics and trending Development of Quality Metrics, and coordination of quality data collection and analyses for use in monthly metrics meetings and Management Reviews Provide quality assurance support cross-functionally across the organization Develop, implement, and manage Quality Control/Quality System process improvements. Identify opportunities for improvement within the Quality System to ensure compliance and efficiency. Correct or improve gaps/opportunities in an independent fashion by writing and releasing new or revised Quality System documentation Understand how and when to escalate quality issues to leadership team within the organization, presenting data and information necessary to draw conclusions and take action Provide training and support to employees on quality processes and procedures Support work on quality plans, quality processes Minimum Qualifications: Bachelor's Degree in Engineering, Biomedical Science, or other technical discipline preferred, with 3-6 years of relevant experience in medical device industry, including responsibility for Product Quality and/or Quality Systems A working knowledge of Quality System Standards and regulations, including 21 CFR Part 820, ISO 13485, EU MDR Preferred Qualifications: Ability to multitask, handling multiple projects and changing priorities Experience in the creation and documentation of procedures and processes Must be results-driven and exhibit a sense of urgency Proficiency with Microsoft Office - Word, Excel, PowerPoint and Access experience required Ability to communicate ideas and information clearly, effectively, and frequently (both oral and written) Ability to exercise independent judgment in methods, techniques, and evaluation criteria for obtaining results Ability to act independently to determine methods and procedures Problem-solving skills and the ability to resolve issues as they arise Strong interpersonal skills, with the ability to assimilate with various cross-functional teams Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship or employment visas currently. NextPhase.ai is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Alexander Technology Group is looking for a Quality Engineer for a client based in the Portsmouth, NH area. This is full-time (perm) On-site in Portsmouth, NH Key Responsibilities: Develop and maintain quality systems for combination products. Ensure compliance with FDA, ISO 13485, cGMP, and other standards. Lead risk assessments, root cause analyses, and corrective actions. Oversee testing, validation, and documentation processes. Collaborate with R&D, manufacturing, and regulatory teams. Conduct training on QA practices and support continuous improvement. Perform inspections and product testing to ensure quality standards. Qualifications: Bachelor's in Engineering, Life Sciences, or related field. Strong knowledge of regulatory requirements and quality tools (e.g., Six Sigma, CAPA, FMEA). Excellent problem-solving and communication skills. Able to work independently in a small team environment. Preferred: Experience with design control, eQMS, and statistical tools. ASQ CQE certification. 3+ years in QA/QE roles with combination products. If interested, please send resume to ************************

Employment Type: Full-Time, On-Site Salary Range: $70,000-$109,000/year A leading life sciences organization is seeking a CQV Engineer / Validation Engineer to support commissioning, qualification, and validation activities for manufacturing equipment, systems, and processes in a GMP-regulated environment. This role requires strong experience authoring and executing protocols in ValGenesis and familiarity with electronic protocol management systems. Key Responsibilities Author, edit, and execute commissioning, qualification, and validation documentation (URS, IQ, OQ, PQ) using ValGenesis Manage deviation investigations and root cause analysis; support CAPA resolution Support change management activities, including impact assessments and regression analysis Execute test scripts and document results; maintain clear, detailed records Collaborate with cross-functional teams to meet project timelines Ensure compliance with GxP and 21 CFR Part 11 requirements Qualifications Bachelor's degree in STEM (Engineering, Life Sciences preferred) 3+ years of industry experience in CQV or validation Strong experience authoring and executing protocols in ValGenesis (required) Experience setting up or implementing ValGenesis instances (preferred) Familiarity with validation lifecycle documentation and electronic protocol systems Strong problem-solving and technical writing skills Ability to work full-time onsite in Devens, MA Salary & Benefits Competitive pay plus performance-based incentives Comprehensive benefits: medical, dental, vision, life insurance, disability coverage 401(k) with employer match Paid time off, holidays, and sick time Tuition reimbursement and professional development opportunities

Who We Are: At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented and diverse workforce in our industry. Our commitment to uncompromising focus on quality, compliance, safety, and excellence in delivery shapes everything we do. We are not just looking for skills; we are seeking innovative individuals who have a mindset open to learning and growth, and a desire to make a difference. Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation. Join us on our mission to enable current and next-generation therapeutics to improve and save the lives of patients. Role Overview: This role serves as the site SME for all cleaning validation and verification activities related to intermediate and API manufacturing, including facility surfaces and equipment. You'll work closely with cross-functional teams to ensure regulatory compliance and implement effective cleaning strategies that meet customer expectations. This position is key to maintaining high quality and safety standards across manufacturing operations. Additionally, you'll manage the environmental and purified water monitoring programs to ensure consistent product quality throughout the process. Core Responsibilities: Lead the development, execution, and validation of cleaning procedures for equipment, production lines, and facilities. Write and review cleaning validation protocols and reports in compliance with regulatory requirements, ensuring that all materials are free of any residues or contaminants. Coordinate and conduct sampling (e.g., swab, rinse, and surface) and analytical testing to validate cleaning processes and confirm cleaning effectiveness. Develop and maintain cleaning validation schedules to ensure timely completion of required validations Review cleaning validation data, ensuring it meets established acceptance criteria, and make recommendations for process improvements. Qualifications: Required Minimum 7 years of quality assurance experience with an undergraduate degree in engineering, science or related field Minimum of 3 years of experience in contamination control, cleaning validation, environmental monitoring, and/or purified water systems, preferably in a pharmaceutical or biotech manufacturing environment (API CDMO experience is highly desirable) Proven leadership experience in pharmaceutical, API/intermediate, medical device, biologics or related FDA industry Strong knowledge of cGMP, FDA, EMA, ICH guidelines, and other regulatory standards related to contamination control, cleaning validation, environmental monitoring, and purified water systems Experience with microbiological sampling, environmental monitoring, and testing of purified water systems in a regulated pharmaceutical environment Proficiency with risk assessment tools such as FMEA Previous experience working in cross-functional and project-based environments Experience creating metrics for driving continuous improvement Excellent analytical, written and verbal communication and presentation skills and a mindset that promotes a positive work culture Hands-on experience with cleaning validation, TOC analysis, and bioburden reduction strategies Driven and detail-oriented, with a strong understanding of cGMP regulations and previous experience in cleaning validation Experience driving complex projects with the ability to initiate, prioritize, and successfully complete tasks Proven experience working effectively in team situations and as an individual contributor Demonstrated behaviours that model the Veranova culture to achieve an inclusive environment and exceptional business results The ideal candidate will have hands-on experience with sterile and cleaning validation processes, strong technical writing skills, and the ability to execute validation protocols independently Experience in a fast-paced work environment Preferred Certification in contamination control (e.g., PDA Certification in Contamination Control). Knowledge of risk-based approaches to cleaning validation (e.g., Risk Assessment and ICH Q9) Experience with continuous improvement methodologies such as Lean or Six Sigma desire Familiarity with environmental monitoring equipment and purified water system design and validation Salary Range : $90,000 - $100,000 annual base salary Our Commitment: Health & Wellness: Comprehensive health & wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies. Financial Wellness: Veranova is committed to fair and transparent compensation practices. This includes a competitive base salary, eligibility for performance-based bonuses, and an attractive 401(k) Plan with company match. Salary ranges reflect the scope and expectations of the role, and are based on market data, internal equity, and role-specific factors. Final compensation may vary depending on experience, skills, education, and business needs. Professional Development: Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs. Inclusive Culture: At Veranova, an inclusive culture is integral to our values. We welcome people with diverse experiences and perspectives who share our mission to improve and save lives. Even if you don't meet every qualification, we encourage you to apply. Veterans, first responders, and those transitioning from military to civilian life bring valuable skills that strengthen our team. Additional Information: Applicants for this role must be authorized to work in the United States without further employer sponsorship. Agency and Search Firm Representatives: Veranova does not accept unsolicited resumes from agencies and/or search firms for this job posting. All your information will be kept confidential according to EEO guidelines. Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law. All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice .

Join a fast-paced engineering team building cutting-edge electrophysiology and connected medical technologies. As a Senior DevOps Tools Engineer, you'll design and automate the systems, workflows, and dashboards that accelerate product development and strengthen software quality across a highly regulated medical platform. You'll partner closely with engineering, QA, and technical leadership to streamline development processes, build automation that reduces friction, and enable teams to deliver reliable, compliant software at scale. What we offer you in USA We honor the contract terms you prefer. 20 paid vacation days per year 40 working hours per week Retirement Plan 401(K) Medical, Dental, Vision Insurance Plan for you and your Family 100% On-Site position in Newton What You'll Do Design, build, and maintain internal tools, scripts, and dashboards that support development, testing, and verification. Automate workflows across JIRA, Polarion, TestRail, and other platforms to boost efficiency and traceability. Create dashboards and automated reports that give teams real-time insight into quality, coverage, and development progress. Work with cross-functional stakeholders to gather requirements and deliver tailored tooling solutions. Identify gaps in existing processes and drive continuous improvement in a regulated environment. Support AWS-based development pipelines and help teams develop, validate, and deploy cloud-enabled workflows. Required Qualifications Bachelor's degree with 4+ years of software verification experience, or Master's with 2+ years. Familiarity with medical device development standards (IEC 62304, FDA guidance). Strong automation and scripting skills (Python, C++/C#, or similar). Previous experience with AWS cloud environment Experience integrating and automating tools such as JIRA, Polarion, and TestRail. Strong problem-solving abilities and attention to detail. Solid understanding of documentation best practices. Preferred Qualifications Experience with Git and modern version control workflows. Knowledge of HTML, Flask, Nginx, or related web technologies. Experience working in Agile development environments. Strong communication skills and the ability to collaborate in fast-paced teams. Self-starter with entrepreneurial drive and ownership mentality.

This role is for a Lead Turbine Airfoils Advanced Quality Engineer within the Product Safety & Quality organization. The Advanced Quality Engineer is an accomplished and forward-thinking Quality Engineer that will serve as the strategic arm of our Turbine Airfoil Quality organization. Reporting directly to the Part Family Advanced Quality Leader, this role is pivotal in driving proactive transformations, lead strategic initiatives that enhance quality processes and outcomes, implement policy enhancements to address systemic issues, and fostering a culture of operational and problem solving excellence. The successful candidate will support across the part family to perform Root Cause and corrective actions, read-across activities, standardization, and implement permanent tactical and systemic corrective actions across the part family. This team will also be pivotal in supporting and equipping the broader Turbine Airfoils Quality team with the skills and methodologies needed to achieve superior execution, redesigning processes to align with organizational objectives and continuous improvement principles to create a culture of team based problem-solving and standardization within the manufacturing shops & suppliers and across the value stream. Travel in this role is likely to be 10-50% depending on part family performance and needs. Travel will be primarily to the Turbine Airfoil sites in Eastern United States **Job Description** **Roles and Responsibilities** + Individual contributor with expertise in Quality and/or Turbine Airfoils, with ability to mentor and influence with indirect leadership skills. + Requires an individual contributor with indirect leadership skills and ability to develop talent. Utilizes in-depth knowledge of Turbine Airfoils design & Quality, and analytical thinking to execute policy/strategy. + Helps to define and leads the implementation of the quality organization, process and tools to support strategy. It implements a culture of Quality in the organization and defines and leads improvement initiatives to achieve business excellence. + Assist directly in developing expertise within Quality and Turbine Airfoils manufacturing team. Pivotal to the cultural and technical transformation of the TAVS quality team. + Grow the reputation of the organization. Creates and Influences policy and ensures delivery within own function, linking with other functions of the organization. + Communicates complex messages and negotiates internally and externally with others. Influences peers to take action and may negotiate with external partners, vendors, or customers. + Has moderate influence on part family Quality + Supports diverse cross-functional teams to find creative solutions to address complex problems that may impact the organization. Has the ability to evaluate quality of information received and questions conflicting data for analysis. Uses multiple internal and external resources outside of own function to help arrive at a decision. **Required Qualifications** + Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 4 years of experience in Turbine Airfoil Quality). + Additional 3 years experience in Turbine Airfoils Quality, Castings, Manufacturing, and/or Engineering + US Person (Refer to Internal Revenue Code section 7701(a)(31) for the definition ) **Desired Characteristics** + Quality Expertise and/or Turbine Airfoil Mechanical Design Expertise + Focused: quick learner, strategically prioritizes work, accountable + Strong Recognized Leadership ability, strong communicator, decision-maker, collaborative + Established project management skills. + Humble: respectful, receptive, agile, eager to learn + Transparent: shares critical information, speaks with candor, contributes constructively + Problem solver: analytical-minded, challenges existing processes, critical thinker + Strong oral and written communication skills. Strong interpersonal and leadership skills. Demonstrated ability to analyze and resolve problems. Demonstrated ability to lead programs / projects. Ability to document, plan, market, and execute programs. Established project management skills. GE Aerospace offers comprehensive benefits and programs to support your health and, along with programs like HealthAhead, your physical, emotional, financial and social wellbeing. Healthcare benefits include medical, dental, vision, and prescription drug coverage; access to a Health Coach from GE Aerospace; and the Employee Assistance Program, which provides 24/7 confidential assessment, counseling and referral services. Retirement benefits include the GE Aerospace Retirement Savings Plan, a 401(k) savings plan with company matching contributions and company retirement contributions, as well as access to Fidelity resources and planning consultants. Other benefits include tuition assistance, adoption assistance, paid parental leave, disability insurance, life insurance, and paid time-off for vacation or illness. GE Aerospace (General Electric Company or the Company) and its affiliates each sponsor certain employee benefit plans or programs (i.e., is a "Sponsor"). Each Sponsor reserves the right to terminate, amend, suspend, replace or modify its benefit plans and programs at any time and for any reason, in its sole discretion. No individual has a vested right to any benefit under a Sponsor's welfare benefit plan or program. This document does not create a contract of employment with any individual. The base pay range for this position is 88,000.00 - 117,000.00 - 146,000.00 USD Annual. The specific pay offered may be influenced by a variety of factors, including the candidate's experience, education, and skill set. This position is also eligible for an annual discretionary bonus based on a percentage of your base salary/ commission based on the plan. This posting is expected to close on January 12, 2026.. _This role requires access to U.S. export-controlled information. Therefore, employment will be contingent upon the ability to prove that you meet the status of a U.S. Person as one of the following: U.S. lawful permanent resident, U.S. Citizen, have been granted asylee or refugee status (i.e., a protected individual under the Immigration and Naturalization Act, 8 U.S.C. 1324b(a)(3))._ **Additional Information** GE Aerospace offers a great work environment, professional development, challenging careers, and competitive compensation. GE Aerospace is an Equal Opportunity Employer (****************************************************************************************** . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE Aerospace will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). **Relocation Assistance Provided:** Yes \#LI-Remote - This is a remote position GE Aerospace is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

The Product Quality Engineer I will be responsible for quality assurance activities including product quality engineering, non-conforming material report write ups and investigation, statistical process control, process improvements, and quality control oversight. Essential Duties and Responsibilities: • Develop and maintain strong internal working relationships across Conformis. • Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals. • Prioritize and plan work activities; adapt for changing conditions. • Assist in maintaining the quality system in accordance with applicable regulatory requirements. • Identify quality system process improvements and implement solutions. • Assist with the Corrective/Preventive Action (CAPA) program. • Assist with the Customer Complaint system by performing complaint investigations, including root cause analysis. • Assist with product inspections as needed. • Perform Internal Quality Audits of the quality system • Participate in supplier selection and approval process, including supplier audits and review of quality data. • Perform investigations of non-conformances and drive corrective actions. • Participate on cross-functional product development teams. • Participate in product/process validations. • Perform risk assessments, gathering cross-functional team input. • Establish and trend quality metrics and data. • Participate in third party audits against ISO 13485 and FDA 21 CFR Part 820 requirements. • Other responsibilities as assigned. Qualifications: • Bachelor of Science in Engineering, Science, or Biomedical. • 3 months to 2 years of Quality Assurance/Quality Engineering experience in an FDA regulated environment - preferably QSR (21 CFR Part 820) Skills, Abilities, Competencies Required: • Excellent written and verbal communication skills. • Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail. • Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness. • Strong organizational, analytical, and time-management skills. • Able to self-motivate and work both independently and as part of a team. • Must have a solid knowledge of Microsoft office. • Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail. restor3d/ Conformis is an Equal Opportunity Employer

At Spindrift, we're making every beverage a positive force of nature. Founded in 2010, we believe the best flavors come directly from nature. That's why every Spindrift beverage is made the hard way-with real squeezed fruit, never from concentrate. From sourcing the best-tasting fruit globally to maintaining a carefully honed manufacturing process, we believe in doing things the hard way, the intentional way, the better albeit more challenging way, the right way - because, in the end, it's worth it. Spindrift sparkling water is available nationwide, and Spindrift Spiked and Spindrift SODA is available in select markets. We are also a proud member of 1% for the planet, donating to environmental causes. Spindrift is headquartered in Newton, MA. The Quality Technician Role The Quality Technician will be responsible for supporting the Spindrift quality program across Spindrift's beverage portfolio, assist with maintenance of the retain library, assistance with recruiting and training internal sensory panelists, assist with collecting, synthesizing and archiving data as it relates to quality initiatives. Responsibilities include: * Assisting the Sensory Analyst with managing the Spindrift sensory program by supporting new panelist onboarding and training, product retain tastings onsite, raw material evaluations, and standard production retains * Assisting with managing the Product Retain Library to ensure it is neatly organized at all times, including maintaining an orderly process of receiving/processing product retains into the library upon arrival and the disposal/removal of out-of-date code samples * Supporting the creation and organization of quality documentation (i.e. SOPs, protocols, training documents and more as needed) * Collaborating with various teams within operations on the following activities: * Finished product releases as needed, including review of finished micro reports and sensory evaluations * Production holds as needed, including performing sensory evaluations on finished product and communicating results to relevant parties * Assist with qualification of new suppliers, including performing required sensory evaluation of raw materials to determine acceptability for use * Data entry and approval for specified raw materials into quality management system * Assist with consumer complaint process, to include but not limited to: data entry, sample collection, investigation support

Responsibilities include biomanufacturing, bioreactor use, and integration of protein expression and downstream processes for biopolymer synthesis and purification. will join cross-functional team-based projects with synthetic biology.

Sanford, Maine 80-115K + Bonus + Full Benefits The Quality Process Engineer acts as a critical link between Innovation/Technical Development teams and Plant Operations/Quality Assurance. This role is responsible for driving plant quality performance and continuous consumer satisfaction through meticulous process optimization, robust technical transfer, and comprehensive validation leadership in a regulated manufacturing environment. The successful candidate must thrive in an energetic, fast-paced setting while maintaining strict attention to detail and promoting effective internal and external networking. Key Responsibilities Process Validation & Quality Compliance Leadership: Oversee and manage the site validation program, including Cleaning and Sanitization (C&S) validation plan leadership and execution. Conduct risk analysis, maintain and update the Validation Master Plan, and develop Performance Qualification (PQ) protocols, supporting IQ/OQ in partnership with the Engineering team. Ensure compliance with quality standards, including cGMP and 21 CFR 210 & 211. Technical Transfer & System Management: Lead the Technology Transfer Quality Standard application specific to site activities. Manage SAP item setup and ensure accountability for the Management of Change (MOC) process. Lead the creation, optimization, and management of Inbatch recipes. Conduct technical reviews of changes in specifications, processes, formulas, packaging, and labeling to ensure product quality. Ensure site quality systems are configured for current and upcoming production requirements in a timely manner. Operations Support & Continuous Improvement: Provide daily on-the-floor support to address quality issues and continuous improvement initiatives, actively participating in site Standard Daily Meetings (SDM) and Internal Quality Area Meetings. Utilize quality tools such as Change Control, Failure Investigation, Control Charts, Corrective & Preventive Actions (CAPA), and Notice of Deviations to drive continuous improvement. Lead product inspections, line trials, and other Quality Key Performance Indicator (KPI) activities. Cross-Functional Partnership & Training: Interface effectively with key business partners including Operations, Technology, Procurement, and Vendors. Conduct training sessions on topics like GMP, quality standards, and validation. Requirements Required Qualifications Education: Bachelor's degree in Chemical / Mechanical Engineering, Chemistry, or a related science/engineering discipline. Experience: A minimum of 2-3 years of experience in manufacturing, a quality role, or equivalent. (Mid-Senior level experience preferred). Skills: Demonstrated project management skills and the ability to communicate effectively and deliver results in a fast-paced work environment. Preferred Qualifications A strong background in quality systems, process validation, and a thorough understanding of cGMP and 21 CFR 210 & 211. Prior experience working in a regulated industry (e.g., FDA-regulated). Working knowledge of SAP, validation software (e.g., KNEAT), InBatch, or similar plant/quality-related computer systems.

About the job Title: Quality Systems Specialist Employment Type: Contract Duration: 6+ months Status: Accepting Candidates About the Role We're hiring a Quality Systems Specialist to support global Quality Systems operations for a leading biopharmaceutical manufacturing organization. This role is heavily focused on documentation, training, system governance, and validation support within a regulated GxP environment. Key Responsibilities Support Quality Systems operations to ensure compliance with SOPs and regulatory requirements (FDA, EMA, ICH) Assist with governance of Quality System applications, including harmonization across sites Gather and document system requirements through workshops and meetings with SMEs and process owners Participate in user forums to collect, prioritize, and triage enhancement requests and system issues Initiate, manage, and complete change controls, including required documentation Maintain systems in a validated state (user access reviews, change management, deviation & CAPA support) Support investigation, escalation, and resolution of system-related issues Execute validation activities, including requirements gathering, validation planning, IQ/OQ support, test scripts, execution, discrepancy management, and validation reporting Provide system administration, user onboarding, and training support Qualifications Experience supporting Quality Systems in a biopharma / pharmaceutical / life sciences environment Strong background in documentation-heavy roles (SOPs, training materials, change controls) Hands-on experience with change management, deviations, and CAPA Familiarity with validated systems and GxP compliance Exposure to QMS tools (e.g., TrackWise, Veeva, MasterControl) is strongly preferred Strong communication skills and ability to work cross-functionally Compensation (MA Pay Transparency) Estimated hourly range: $40-$50/hr (W-2) Final rate within the posted range will be based on skills, experience, and interview results

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 ****************** .

This role is for a Lead Turbine Airfoils Advanced Quality Engineer within the Product Safety & Quality organization. The Advanced Quality Engineer is an accomplished and forward-thinking Quality Engineer that will serve as the strategic arm of our Turbine Airfoil Quality organization. Reporting directly to the Part Family Advanced Quality Leader, this role is pivotal in driving proactive transformations, lead strategic initiatives that enhance quality processes and outcomes, implement policy enhancements to address systemic issues, and fostering a culture of operational and problem solving excellence. The successful candidate will support across the part family to perform Root Cause and corrective actions, read-across activities, standardization, and implement permanent tactical and systemic corrective actions across the part family. This team will also be pivotal in supporting and equipping the broader Turbine Airfoils Quality team with the skills and methodologies needed to achieve superior execution, redesigning processes to align with organizational objectives and continuous improvement principles to create a culture of team based problem-solving and standardization within the manufacturing shops & suppliers and across the value stream. Travel in this role is likely to be 10-50% depending on part family performance and needs. Travel will be primarily to the Turbine Airfoil sites in Eastern United States **Job Description** **Roles and Responsibilities** + Individual contributor with expertise in Quality and/or Turbine Airfoils, with ability to mentor and influence with indirect leadership skills. + Requires an individual contributor with indirect leadership skills and ability to develop talent. Utilizes in-depth knowledge of Turbine Airfoils design & Quality, and analytical thinking to execute policy/strategy. + Helps to define and leads the implementation of the quality organization, process and tools to support strategy. It implements a culture of Quality in the organization and defines and leads improvement initiatives to achieve business excellence. + Assist directly in developing expertise within Quality and Turbine Airfoils manufacturing team. Pivotal to the cultural and technical transformation of the TAVS quality team. + Grow the reputation of the organization. Creates and Influences policy and ensures delivery within own function, linking with other functions of the organization. + Communicates complex messages and negotiates internally and externally with others. Influences peers to take action and may negotiate with external partners, vendors, or customers. + Has moderate influence on part family Quality + Supports diverse cross-functional teams to find creative solutions to address complex problems that may impact the organization. Has the ability to evaluate quality of information received and questions conflicting data for analysis. Uses multiple internal and external resources outside of own function to help arrive at a decision. **Required Qualifications** + Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 4 years of experience in Turbine Airfoil Quality). + Additional 3 years experience in Turbine Airfoils Quality, Castings, Manufacturing, and/or Engineering + US Person (Refer to Internal Revenue Code section 7701(a)(31) for the definition ) **Desired Characteristics** + Quality Expertise and/or Turbine Airfoil Mechanical Design Expertise + Focused: quick learner, strategically prioritizes work, accountable + Strong Recognized Leadership ability, strong communicator, decision-maker, collaborative + Established project management skills. + Humble: respectful, receptive, agile, eager to learn + Transparent: shares critical information, speaks with candor, contributes constructively + Problem solver: analytical-minded, challenges existing processes, critical thinker + Strong oral and written communication skills. Strong interpersonal and leadership skills. Demonstrated ability to analyze and resolve problems. Demonstrated ability to lead programs / projects. Ability to document, plan, market, and execute programs. Established project management skills. GE Aerospace offers comprehensive benefits and programs to support your health and, along with programs like HealthAhead, your physical, emotional, financial and social wellbeing. Healthcare benefits include medical, dental, vision, and prescription drug coverage; access to a Health Coach from GE Aerospace; and the Employee Assistance Program, which provides 24/7 confidential assessment, counseling and referral services. Retirement benefits include the GE Aerospace Retirement Savings Plan, a 401(k) savings plan with company matching contributions and company retirement contributions, as well as access to Fidelity resources and planning consultants. Other benefits include tuition assistance, adoption assistance, paid parental leave, disability insurance, life insurance, and paid time-off for vacation or illness. GE Aerospace (General Electric Company or the Company) and its affiliates each sponsor certain employee benefit plans or programs (i.e., is a "Sponsor"). Each Sponsor reserves the right to terminate, amend, suspend, replace or modify its benefit plans and programs at any time and for any reason, in its sole discretion. No individual has a vested right to any benefit under a Sponsor's welfare benefit plan or program. This document does not create a contract of employment with any individual. The base pay range for this position is 88,000.00 - 117,000.00 - 146,000.00 USD Annual. The specific pay offered may be influenced by a variety of factors, including the candidate's experience, education, and skill set. This position is also eligible for an annual discretionary bonus based on a percentage of your base salary/ commission based on the plan. This posting is expected to close on January 12, 2026.. _This role requires access to U.S. export-controlled information. Therefore, employment will be contingent upon the ability to prove that you meet the status of a U.S. Person as one of the following: U.S. lawful permanent resident, U.S. Citizen, have been granted asylee or refugee status (i.e., a protected individual under the Immigration and Naturalization Act, 8 U.S.C. 1324b(a)(3))._ **Additional Information** GE Aerospace offers a great work environment, professional development, challenging careers, and competitive compensation. GE Aerospace is an Equal Opportunity Employer (****************************************************************************************** . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE Aerospace will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). **Relocation Assistance Provided:** Yes \#LI-Remote - This is a remote position GE Aerospace is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

The Product Quality Engineer II will be responsible for quality assurance activities including product quality engineering, non-conforming material report write ups and investigation, statistical process control, process improvements, and quality control oversight. Essential Duties and Responsibilities: Develop and maintain strong internal working relationships across restor3d. Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals. Prioritize and plan work activities; adapt for changing conditions. Assist in maintaining the quality system in accordance with applicable regulatory requirements. Identify quality system process improvements and implement solutions. Lead or assist with the Corrective Action/Preventive Action (CAPA) program. Lead or assist with the Customer Complaint system by performing complaint investigations, including root cause analysis. Assist with product inspections as needed. Perform Internal Quality Audits of the quality system Participate in supplier selection and approval process, including leading supplier audits and review of quality data. Perform investigations of non-conformances and drive corrective actions. Participate on cross-functional product development teams. Participate in product/process validations. Perform risk assessments, gathering cross-functional team input. Employ statistical techniques and rationale in decision-making activities driven to support non-conformance trending, CAPA effectiveness, part qualification, and process monitoring. Establish and trend quality metrics and data. Participate in third party audits against ISO 13485 and FDA 21 CFR Part 820 requirements. Other responsibilities as assigned. Qualifications: Bachelor of Science in Engineering, Science, or Biomedical. 2+ years of Quality Assurance/Quality Engineering experience in the medical device industry and/or experience in an FDA regulated environment is required. Knowledge of FDA 21 CFR Part 820 and ISO 13485, preferred. ASQ certification (Certified Quality Engineer, Certified Quality Auditor, Certified Biomedical Auditor) a plus. Skills, Abilities, Competencies Required: Excellent written and verbal communication skills. Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail. Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness. Strong organizational, analytical, and time-management skills. Able to self-motivate and work both independently and as part of a team. Must have a solid knowledge of Microsoft office. Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail. Demonstrated proficiency with FDA and ISO standards for Medical Devices. Restor3d is an Equal Opportunity Employer

Job DescriptionQuality Process Engineer Sanford, Maine 80-115K + Bonus + Full Benefits The Quality Process Engineer acts as a critical link between Innovation/Technical Development teams and Plant Operations/Quality Assurance. This role is responsible for driving plant quality performance and continuous consumer satisfaction through meticulous process optimization, robust technical transfer, and comprehensive validation leadership in a regulated manufacturing environment. The successful candidate must thrive in an energetic, fast-paced setting while maintaining strict attention to detail and promoting effective internal and external networking. Key Responsibilities Process Validation & Quality Compliance Leadership: Oversee and manage the site validation program, including Cleaning and Sanitization (C&S) validation plan leadership and execution. Conduct risk analysis, maintain and update the Validation Master Plan, and develop Performance Qualification (PQ) protocols, supporting IQ/OQ in partnership with the Engineering team. Ensure compliance with quality standards, including cGMP and 21 CFR 210 & 211. Technical Transfer & System Management: Lead the Technology Transfer Quality Standard application specific to site activities. Manage SAP item setup and ensure accountability for the Management of Change (MOC) process. Lead the creation, optimization, and management of Inbatch recipes. Conduct technical reviews of changes in specifications, processes, formulas, packaging, and labeling to ensure product quality. Ensure site quality systems are configured for current and upcoming production requirements in a timely manner. Operations Support & Continuous Improvement: Provide daily on-the-floor support to address quality issues and continuous improvement initiatives, actively participating in site Standard Daily Meetings (SDM) and Internal Quality Area Meetings. Utilize quality tools such as Change Control, Failure Investigation, Control Charts, Corrective & Preventive Actions (CAPA), and Notice of Deviations to drive continuous improvement. Lead product inspections, line trials, and other Quality Key Performance Indicator (KPI) activities. Cross-Functional Partnership & Training: Interface effectively with key business partners including Operations, Technology, Procurement, and Vendors. Conduct training sessions on topics like GMP, quality standards, and validation. Requirements Required Qualifications Education: Bachelor's degree in Chemical / Mechanical Engineering, Chemistry, or a related science/engineering discipline. Experience: A minimum of 2-3 years of experience in manufacturing, a quality role, or equivalent. (Mid-Senior level experience preferred). Skills: Demonstrated project management skills and the ability to communicate effectively and deliver results in a fast-paced work environment. Preferred Qualifications A strong background in quality systems, process validation, and a thorough understanding of cGMP and 21 CFR 210 & 211. Prior experience working in a regulated industry (e.g., FDA-regulated). Working knowledge of SAP, validation software (e.g., KNEAT), InBatch, or similar plant/quality-related computer systems.

Title: Validation Engineer Duration: 6m+ There are 3 roles open here - 2 beginner level (not entirely green but 1-2 yrs is fine) and 1 intermediate level (4+ yrs) KEY RESPONSIBILITIES: Draft and implement Quality System documentation designed to establish good validation practices within the organization. Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guidelines and internal quality standards. Support all stages of qualification of Analytical Instrument and Manufacturing equipment. Support all stages of qualification of automated manufacturing equipment Conduct Analytical Instrumentation Qualifications in accordance with USP and Vertex SOPs. Conduct Automation Assessments to ensure compliance with 21 CFR Part 11. Coordinate with vendor personnel to schedule and execute of test plans, if required. Coordinates with the internal stakeholders to safely and effectively schedule CQV activities, whenever required. Effectively works with cross departmental stakeholders, including but not limited to information services, EH&S, Global Security, design teams, and quality. Author documents related to or support process validation related activities that include but not limited to aseptic process simulations (APS), process performance qualification, material qualifications, etc. Develop cycles for sterilization processes and validate them, if required. Completes assigned training and ensures that they are 100% compliant 100% of the time. Ensure that all Validation activities align with the current SOPs, global standards and cGMP guidelines. Supports right-the-first time culture for all documents distributed across the organization. Ensure the Validation team reputation and partnership is flourished with the cross-functional teams. IDEAL CANDIDATES: Demonstrated ability to safely execute Validation activities in a dynamic fast paced environment. Experience developing and executing Validation protocols in a GMP Manufacturing and Analytical Laboratory areas. Receptive to change - Adapts (quickly) to changing circumstances. Flexibility for off-shift hours, including weekend and night shift work. B.A, B.S. in Engineering or related discipline with 5-8 years of Validation experience or equivalent professional experience. Understanding and application of technical principles, theories, and concepts in the field, GMP, ISO, GAMP, ANSI.

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. Responsibilities Characterize and improve manufacturing process unit operations by designing, executing, and analyzing process development experiments; communicate results via written reports and oral presentations to internal and project teams Support manufacturing scale-up by assessing novel equipment, work flows, analytical techniques/PAT, and process configurations Support manufacturing operations by incorporating equipment and process improvements within established processes and equipment trains, and by revising manufacturing batch records, SOPs, and other controlled documents to reflect changes; contribute to implementing and maintaining Vaxess' Quality System. Supervise and mentor junior engineer(s) and technicians, including a direct report Collaborate closely with cross-functional teams to support product development and manufacturing activities Qualifications BS in Mechanical Engineering, Biomedical Engineering, or a related discipline 5 - 7 years of relevant direct R&D experience within the medical device or biopharmaceutical industries; experience working on combination products is highly desirable Demonstrated success using empirical and first-principles models to inform and analyze experiments; experience with statistical methodologies and working with large data sets (e.g. Six Sigma, DoEs, multivariate techniques) is a plus Excellent time and project management skills and proven ability to meet goals and deadlines Demonstrated abilities to learn new skills and fields, creatively solve challenging technical problems, think independently, and work collaboratively in diverse multidisciplinary teams Entrepreneurial spirit and drive to positively impact global human health 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 ******************.