Quality engineer jobs in Quincy, MA

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.

Must Have Technical/Functional Skills • Knowledge on Quality Management and its tools & techniques • Knowledge about GMP (Good Manufacturing Practices), FDA, ISO 13485 and compliance regulations • Knowledge on Medical Device Regulatory Standards, MDD and MDR • Knowledge on NC, CAPA, Root Cause Analysis and Audit processes • Knowledge on Validation process, writing protocols/ reports • Very good understanding/ experience in writing procedures, product specs and work instructions • Knowledge in Statistics, Risk Management and Design control • Must possess good communication skills (verbal and written), familiar with project management methodology, problem solving, and presentation skills • Experience in creating FMEAs & Writing reports • Experience in PMS (Post Market Surveillance) • Experience in PLM Tool (Windchill) • Good understanding of Design, Drawing and GD&T • Excellent Interpersonal / communication skills, Organizational / planning and Project management skills preferred • Personal computer skills, Windows: word processing, presentation, e-mail, web browsers & spreadsheet software • Ability to work efficiently, meet timelines, and communicate status (generate trackers, send emails, etc.) Roles & Responsibilities • Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, the duties and responsibilities for this position are: • Development and review of PDP (Product development Process) deliverables • Review and approve R&D/ Engineering protocol/ reports • Development of Risk management records (i.e. DFMEA/ PFMEA) in collaboration with SMEs • Support and provide guidance on Validations and if required write Validation Protocols/ Reports • Support/ Remediation of Validation/ Quality Documentation • Support Root Cause Investigation and closure of NC and CAPA • Review and approve the Change Orders (CR/ CN) • Review and update the design/ process control documents like procedures/ work instructions/ product specs etc. • Work with cross functional teams and internal teams to create deliverables • Performs other duties assigned as needed Salary Range: $90,000 $95,000 Year TCS Employee Benefits Summary: Discretionary Annual Incentive. Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans. Family Support: Maternal & Parental Leaves. Insurance Options: Auto & Home Insurance, Identity Theft Protection. Convenience & Professional Growth: Commuter Benefits & Certification & amp; Training Reimbursement. Time Off: Vacation, Time Off, Sick Leave & Holidays. Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.

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.

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 .

WHO WE ARE We are a leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people's lives. Join a company where collaborative, dedicated, and talented people are the backbone of our culture. Work both autonomously and in driven teams to make life-changing products utilizing ground-breaking science. THE ROSLINCT WAY Here at RoslinCT, our team contributes to the development of revolutionary treatments. We live every day by our core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success. At RoslinCT we focus on developing our corporate culture, people's development, growth, and the ability to impact patients. ACCELERATING YOUR FUTURE The Process Engineer I/II will develop and execute technology transfer plans for RoslinCT's client processes, including working with key stakeholders in Manufacturing, Quality, Technology, and Operations departments. As a technical subject matter expert, the position will support routine production with troubleshooting, technical assessments of deviations, and product disposition evaluations. The position will play a key role in optimizing manufacturing processes and test methods, continuously improving quality, efficiency, and reliability while supporting products through clinical development to commercialization. HOW YOU WILL MAKE AN IMPACT Partner with colleagues in Operations, Quality Control, and Quality Assurance as well as external clients and suppliers to plan technology transfer, equipment setup and qualification, engineering and training runs, and process validation as applicable. Support production and QC with process or equipment troubleshooting, deviation management, corrections and CAPA, as needed Execute feasibility testing of new or alternative technologies and engage with key stakeholders to ensure technology development alignment with RoslinCT and Client program requirements Collaborate with internal partners to experimentally determine key process and product monitoring and control attributes, analyze results and draft technical reports to communicate conclusions Perform test runs and development studies as needed to support client and RoslinCT initiatives Compile comprehensive data packages, operating procedures, and technical documentation to support technology transfer and process improvement Be proactive in identifying opportunities to add value to processes and cross-functional teams WHAT YOU WILL BRING B.Sc. in Biological or Chemical Engineering (or similar) with 2-10 years of relevant process and/or analytical experience within the Cell and Gene Therapy or Biologics industry Hands-on experience with aseptic manufacturing processes, cell culture, and process analytics Experience with equipment support and troubleshooting Demonstrated independence in experimental design, execution, data analysis, and troubleshooting Preferred Qualifications Advanced degree or additional certifications in science, engineering, or cGMP operations Experience with bioreactor cell culture Experience with cell selection, cell washing, lentiviral transduction, and cryopreservation Experience with Microsoft Excel and statistical programs for data analysis and visualization Excellent technical writing and oral communication skills Driven and works well independently and within cross-functional teams *May serve in an “on call” rotation to respond remotely to urgent issues (~1 week per month) OUR COMMITMENT All RoslinCT employees embrace the principles of our culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. RoslinCT is proud to be an equal opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.

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.

FM Approvals is an international leader in third-party testing and certification services. We test property loss prevention products and services-for use in commercial and industrial facilities-to verify they meet rigorous loss prevention standards of quality, technical integrity and performance. How? By employing a worldwide certification process that's backed by scientific research and testing, and over a century of experience. The FM APPROVED mark is recognized and respected worldwide. Our certification instills confidence and commands respect in your marketplace. Perform assigned tests, investigations or experiments. This may require minor modifications in test setups or procedures as well as subjective judgments in measurement. Selects, sets up, and operates standard test equipment and records technically sound test data within budgetary and time constraints. Fabricate and construct necessary testing apparatus from existing components. Set-up and tear-down operations for routine investigations and tests. Trouble-shoot all problems and take corrective actions. Use specialized equipment and apparatus to collect data, calculate or record results, prepare reports and/or technical data. Prepare and present clear and concise data in a prescribed format. Provide requested advice in areas of specialization to superiors and peers and technical directions to subordinates. Increase your knowledge of testing procedures and related technological advances so as to contribute to personal development and the achievement of personal and unit goals and objectives. Keep the supervisor informed of the status and progress of all work in process and of any significant developments affecting assigned projects. Education: High School / Trade School or Military specialist experience Experience (Eng Tech): 3 years general construction and 1 year laboratory experience ideal Skills/Knowledge: Laboratory testing, product assembly, equipment repair, mathematical computation or data tabulation, use of laboratory test equipment and computer literacy. Good mechanical skills with familiarity of common hand tools and power tools, ability to work independently. Must be able to work while wearing full Firefighter's Turnout gear with SCBA for an extended period of time in a wet and smoky environment Must be able to obtain certification for using a personal respirator and work while wearing one for an extended period of time in a wet and smoky environment Excellent communication and customer service skills (both orally and in writing) and the ability to work effectively as a member of a team are required. Ability to read, write and speak English proficiently. Ability to understand and follow English instructions Ability to push, pull, lift and carry up to 50 pounds (unassisted) on a regular basis; up to 75 pounds occasionally. Ability to safely and efficiently operate power equipment such as: cranes, fork lifts and other material handling devices, use ladders, operate tools such as, but not limited to, table saws, portable saws, hammer drills, screw guns and impact wrenches and be certifiable for the use of a respirator. Candidate must possess good balance to regularly step on and off equipment and work from ladders and platforms to perform various tasks. The final salary offer will vary based on geographic location, individual education, skills, and experience. The position is eligible to participate in FM's comprehensive Total Rewards program that includes an incentive plan, generous health and well-being programs, a 401(k) and pension plan, career development opportunities, tuition reimbursement, flexible work, time off allowances and much more. FM Approvals is an Equal Opportunity Employer and is committed to attracting, developing, and retaining a diverse workforce. #LI-TA1

The Ryan White Dental Program (RWDP) is a comprehensive dental access program for persons living with HIV/AIDS in Massachusetts and Southern New Hampshire, funded under Ryan White Part A and with funds from the Massachusetts Department of Public Health. Services funded are recruitment of dentists and preventive, diagnostic and therapeutic services rendered by licensed dentists and dental hygienists. Under the supervision of the Director of the Ryan White Dental Program , the Clinical/Quality Management Program Manager of RWDP will be responsible for clinical quality improvement, reviewing eligibility for clients accessing services; providing technical and monitoring assistance to assure dental vendors attain contracted goals & objectives; monthly reporting of program activities; maintaining consistent contact with dental providers and other parties as needed; and working collaboratively with program & fiscal staff to ensure system accountability. Responsibilities Review dental treatment plans and history to determine appropriate options for people living with HIV (PLWH) seeking dental care to be reimbursed by the program Provide initial review of dental claims, including client eligibility, dental billing codes, and prior approvals Review past billing and client dental records to prevent duplicate or improper billing for services Monitor monthly prior approval expenditures and assist in reconciliation of payments in coordination with other Dental and BPHC fiscal staff With the assistance of other RWDP staff, review and update annual Scope of Services documents for dental contracts, including client eligibility, fee schedules, and other requirements With the assistance of other RWDP staff, develop and update a Standard Operating Procedures (SOP) manual, including policies and procedures for Dental staff, vendors, and clients; the client enrollment process; recruitment of vendors; and reimbursement process for dental services. Draft and revise quality management plan for the program, including tracking of health and quality of life indicators, dental standards of care, and quality improvement activities Conduct regular research into the most current dental best practices and disseminate such content to a diverse audience, including HIV service providers and clients Provide support on presentations to both internal and external stakeholders on the impact of services on the oral health care needs of PLWH Regularly attend programmatic meetings Handle communication with clients, dental providers, and others Perform other duties as required

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 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.

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 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. 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 is an Equal Opportunity Employer

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.

SRE with Sterling OMS Skillset with adaptability to Distributed Systems, developing Automations with AI/GenAI tool etc Operations skillset with enough attitude to scale to a Reliability Engineer. Should be able to handle customer communication and coordination with offshore team. # LI-RJ2 Salary Range - $100,000-$120,000 a year

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

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

Execute aseptic process simulations (APS) and support process validation activities, including documentation, execution, and result review. Develop and author validation protocols such as URS, IQ, OQ, and PQ in alignment with GDP and GMP standards. Perform equipment and analytical instrument qualification following regulatory and internal guidelines. Conduct automation and software compliance assessments to ensure adherence to 21 CFR Part 11 requirements. Coordinate cross-functional activities with engineering, quality, IT, vendors, and operations to complete CQV (Commissioning, Qualification & Validation) tasks. Support validation of automated manufacturing systems and sterile process controls. Maintain accurate, audit-ready validation documentation in compliance with quality system requirements. Participate in off-shift or weekend APS execution while maintaining a standard 40-hour workweek. Ensure all work aligns with applicable SOPs, regulations, and Good Documentation Practices (GDP).