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Quality assurance manager jobs in New Bedford, MA

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  • Director of Quality

    Green Life Science

    Quality assurance manager job in Boston, MA

    We're hiring a Director of Quality to lead QA/QC operations at our U.S.-based Contract Development & Manufacturing Organization (CDMO). This senior leader will ensure GMP compliance, oversee product release, and drive quality excellence across our clinical and commercial manufacturing programs. What You'll Do Lead QA, QC, and Quality Systems teams; build a strong quality culture Oversee batch record review, product disposition, and client quality interactions Maintain and improve GMP compliance, CAPA, deviations, change control, and training systems Prepare the site for regulatory inspections (FDA, EMA) and client audits Provide quality oversight for manufacturing, tech transfers, and validation activities Drive continuous improvement, data integrity, and inspection readiness What We're Looking For Bachelor's in science or engineering (advanced degree a plus) 10+ years in GMP pharmaceutical manufacturing; 5+ years in Quality leadership Strong command of FDA/EMA regulations, ICH guidelines, and CDMO environment Proven success managing inspections, audits, and client relationships Experience with aseptic, biologics, or high-potency APIs is a plus Why Join Us? Lead quality for a growing CDMO with diverse product portfolios Influence site strategy and partner closely with clients and regulators Competitive compensation, bonus, benefits, and development opportunities
    $123k-164k yearly est. 4d ago
  • Senior Quality Assurance Associate

    Aequor 3.2company rating

    Quality assurance manager job in West Greenwich, RI

    Quality Assurance Senior Associate with GMP and Quality or Manufacturing Experience (Onsite Job in West Greenwich, RI) Terms: Contract W2 Duration : 12 Months Contract (Will Get Extended for Long) Description: 100% onsite ARI Location: Onsite - West Greenwich, RI Schedule: Administrative Shift | 8:30 AM - 5:00 PM (with 30 minute meal break) Contract Length:12 months with potential for extension Preferred Qualifications: • Bachelor's Degree in a relevant field (e.g. Life Sciences) • Minimum of 2 year of experience in Quality or Manufacturing, with exposure to F&E-related activities. • Strong understanding of cGMP principles and regulatory expectations. • Demonstrated experience utilizing enterprise systems such as Maximo, OEFM, MES, and Veeva Vault (CDOCS/DQMS) to support quality oversight, documentation management, and manufacturing execution processes. • Proficient in Microsoft Office applications, including Outlook, Word, Excel, PowerPoint, and Teams. • Excellent written and verbal communication skills. • Experience collaborating within and across functional areas, with a strong focus on customer service and partnership. • Demonstrated ability to make sound decisions in a dynamic, fast-paced environment. • Ability to prioritize and navigate ambiguity, with minimal Skill Sets: 1) Ability to prioritize and navigate ambiguity, with minimal oversight, in a fast-paced environment. 2) Exposure to F&E operations (including experience with documentation (both paper based and Electronic) 3) GMP experience (MFG, Quality, or F&E)
    $77k-100k yearly est. 1d ago
  • Quality Systems & Investigations Specialist

    JMD Technologies Inc.

    Quality assurance manager job in Boston, MA

    Title: Quality Systems & Investigations Specialist Employment Type: Contract Status: Accepting Candidates About the role This position plays a key role in supporting daily manufacturing activities by resolving operational issues and driving high-quality investigations. The role ensures process reliability through strong technical oversight and collaboration with critical operations teams. Key Responsibilities • Lead real-time floor support, triaging deviations and initiating root cause investigations. • Produce thorough, compliant quality documentation for deviations, CAPAs, and impact assessments. • Partner with manufacturing, QC, facilities, and materials teams to define corrective and preventive actions. • Apply structured scientific thinking to evaluate data and support operational decisions. • Contribute to process improvement by identifying trends and proposing optimized workflows. Qualifications • 6+ years experience in pharma/biotech manufacturing environments. • Proven background in investigations, RCA, QC analytics, and GxP documentation. • Skilled in cross-functional coordination and rapid issue assessment. • Strong analytical mindset with the ability to interpret complex data sets. • Experience supporting manufacturing operations in fast-paced, regulated environments. Compensation (MA Pay Transparency): • Estimated hourly range: $50-$58/hr (W-2). • Final rate within this range will be based on skills, experience, and interview results.
    $50-58 hourly 1d ago
  • POS Quality Engineer

    Kellymitchell Group 4.5company rating

    Quality assurance manager job in Canton, MA

    Our client is seeking a POS Quality Engineer to join their team! This position is located in Canton, Massachusetts. Execute functional testing for the client's POS systems in a lab environment Validate new POS features, patches, upgrades, and configuration changes Troubleshoot issues across POS hardware, networking, integrations, and payment systems Review logs, identify root causes, and escalate defects to internal teams and vendors Collaborate with vendors delivering POS products to ensure quality and readiness Support daily version testing, weekly releases, and continuous enhancements Maintain test cases, regression suites, and documentation Ramp up on the clients POS systems, environments, and workflows Execute manual testing independently and efficiently Understand integration points with kiosk, mobile apps, loyalty, and payments Build relationships with product, engineering, and vendor teams Contribute to expanding and maintaining POS test automation frameworks Improve test coverage, defect identification, and issue resolution speed Work independently with minimal oversight while communicating affectively Support performance-related testing for high-volume transaction scenarios Help streamline testing workflows to support frequent deployments Desired Skills/Experience: 5+ years of POS Quality Engineering experience Hands-on experience with any POS system such as: Aloha, Toast, NCR, Oracle Symphony, or other enterprise/custom POS systems Experience with payment systems such as: VeriFone, kiosk integrations, loyalty platforms, mobile ordering, and web integrations Strong manual testing proficiency with the ability to execute tests quickly and accurately Ability to troubleshoot logs, hardware, and light networking issues Experience collaborating with third-party vendors on POS deliverables Familiarity with automation frameworks and ability to contribute to automation improvements Prior experience working in a POS lab environment (devices, staging stores, simulators) Strong communication, organization, and self-management skills Benefits: Medical, Dental, & Vision Insurance Plans Employee-Owned Profit Sharing (ESOP) 401K offered The approximate pay range for this position is between $55.00 and $65.00. Please note that the pay range provided is a good faith estimate. Final compensation may vary based on factors including but not limited to background, knowledge, skills, and location. We comply with local wage minimums.
    $55-65 hourly 4d ago
  • NPD Quality Engineer

    Tata Consultancy Services 4.3company rating

    Quality assurance manager job in Plymouth, MA

    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.
    $90k-95k yearly 1d ago
  • Quality Engineer (Edifecs Project)

    JCW Group 3.7company rating

    Quality assurance manager job in Boston, MA

    🚀 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.
    $81k-107k yearly est. 3d ago
  • Director, Regulatory Affairs and Quality Assurance

    Whoop 4.0company rating

    Quality assurance manager job in Boston, MA

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

    Massachusetts Eye and Ear Infirmary 4.4company rating

    Quality assurance manager job in Boston, MA

    Site: The Brigham and Women's Hospital, 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 Summary Responsible for building, providing, coordinating, and, facilitating comprehensive training and education on the use, maintenance, and troubleshooting of biomedical equipment to BME technical staff. Does this position require Patient Care? No Essential Functions - Develop, deliver, coordinate, and facilitate training programs on the use and maintenance of biomedical equipment, including but not limited to diagnostic, therapeutic, and monitoring devices. -Develop and update training materials, user guides, and standard operating procedures (SOPs) for various biomedical devices and technologies. Ensure training programs are aligned with the latest industry standards, safety regulations, and healthcare protocols. -Provide and facilitate practical, hands-on training sessions, demonstrating how to properly set up, operate, and troubleshoot biomedical equipment. Ensure participants achieve competency in equipment use to enhance patient outcomes. -Stays up to date on new technologies, product updates, and advancements in biomedical engineering. -Ensure that all training content adheres to healthcare regulations, safety standards, and compliance guidelines (e.g., FDA, OSHA). -Evaluate the effectiveness of training programs through assessments, feedback, and observation. Identify areas for improvement and adjust training programs to ensure participants meet required proficiency levels. -Work closely with biomedical engineering teams, medical device manufacturers, and technical staff to ensure smooth integration of biomedical equipment into healthcare operations. Qualifications Education Bachelor's Degree Biomedical Engineering required or Bachelor's Degree Related Field of Study required Can this role accept experience in lieu of a degree? Yes Licenses and Credentials Experience Experience in biomedical equipment or other closely related role 3-5 years required and Experience in training, staff development, or other related role 1-2 years preferred Knowledge, Skills and Abilities - Strong technical understanding of biomedical equipment, such as diagnostics, patient monitoring, and therapeutic devices. - Excellent communication and presentation skills, with the ability to convey complex technical concepts to non-technical audiences. - Proficiency in Microsoft Office Suite (PowerPoint, Word) and familiarity with training software or learning management systems (LMS). - Problem-solving skills with an ability to troubleshoot and resolve technical issues in real time during training sessions. Additional Job Details (if applicable) Physical Requirements Standing Frequently (34-66%) Walking Frequently (34-66%) Sitting Occasionally (3-33%) Lifting Frequently (34-66%) Carrying Frequently (34-66%) Pushing Occasionally (3-33%) Pulling Occasionally (3-33%) Climbing Rarely (Less than 2%) Balancing Frequently (34-66%) Stooping Occasionally (3-33%) Kneeling Occasionally (3-33%) Crouching Occasionally (3-33%) Crawling Rarely (Less than 2%) Reaching Frequently (34-66%) Gross Manipulation (Handling) Frequently (34-66%) Fine Manipulation (Fingering) Frequently (34-66%) Feeling Constantly (67-100%) Foot Use Rarely (Less than 2%) Vision - Far Constantly (67-100%) Vision - Near Constantly (67-100%) Talking Constantly (67-100%) Hearing Constantly (67-100%) Remote Type Hybrid Work Location 100 Blossom Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $92,102.40 - $134,056.00/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: The Brigham and Women's Hospital, 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.
    $92.1k-134.1k yearly Auto-Apply 31d ago
  • Director, Clinical Quality Assurance

    Eisai Us 4.8company rating

    Quality assurance manager job in Boston, MA

    At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US, EU Directives, US FDA, PMDA, ICH). Essential Functions * Independently conduct audits * Review and oversee results of CQA audits of study sites, clinical vendors, clinical documents, and internal process audits * Facilitate Sponsor health authority inspections of global clinical facilities and study sites * Continuously drive innovation through active search, evaluation, acquisition, and implementation of high-impact new technologies/ procedures across clinical quality programs * Direct skill-building interventions for CQA staff through cross-functional/ external partnerships to reskill/ upskill and adapt the workforce to evolving technologies. * May be responsible for direct people management including goal setting, performance management, development, and engagement. Requirements * Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related area. * 5+ years of experience in GCP auditing. * Substantial experience in inspection management. * Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of clinical trials. * Demonstrated ability to operate and influence decision-making processes * Effective communication skills * Successful track record of supervising employees and managing cross-cultural differences * Technical and administrative capabilities to independently carry out routine, complex and for-cause audits * Knowledge of data integrity controls and systems quality for clinical area * Strong analytical skills and report writing skills * Experience with GxP systems including computer system validation and associated regulations, recommended. * Ability to Travel (approximately 20%) * Candidates near Eisai's NJ/PA location will be preferred. For candidates near an Eisai location, Remote Work Arrangement will consist of 2-4 days in office (Nutley/Exton) per month and 1-2 audits quarterly; remote audits, are held in Nutley. CQA is also expected to be present in Nutley for any inspections or critical inspection mgmt. activities. Eisai Salary Transparency Language: The base salary range for the Director, Clinical Quality Assurance is from :195,000-256,000 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit *********************************************** Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation
    $116k-159k yearly est. Auto-Apply 60d+ ago
  • Quality Assurance and Compliance Director

    Meadows of Wickenburg 4.0company rating

    Quality assurance manager job in Brookline, MA

    Job Details Bournewood Hospital - Brookline, MA Full Time Bachelors Degree $115000.00 - $125000.00 Salary Regular 8:00 am to 5:00 pm QA - Quality ControlDescription The Quality Assurance and Compliance Director is responsible for developing, implementing, and maintaining the hospital's Quality Assessment and Performance Improvement (QAPI) and Compliance Programs. This position ensures the hospital meets and exceeds standards established by regulatory and accreditation agencies, including The Joint Commission (TJC), the Massachusetts Department of Mental Health (DMH), the Bureau of Substance Addiction Services (BSAS), and the Centers for Medicare & Medicaid Services (CMS). This role works collaboratively with the Chief Nursing Officer, Director of Facility Operations, CEO, and other department leaders to coordinate data-driven quality assurance activities, regulatory compliance functions, and survey preparedness. The position promotes continuous regulatory readiness, supports the hospital's Quality Improvement (QI) Plan, manages incident reporting and patient safety initiatives, and provides education and consultation to staff and leadership regarding compliance and risk standards. The Director provides leadership, coordination, and oversight of all quality and compliance activities, supporting the organization's mission to provide safe, effective, and patient-centered behavioral healthcare. Essential Duties and Responsibilities Program Development & Oversight Develop, implement, and manage the hospital's QAPI and Compliance Programs in alignment with regulatory and accreditation standards. Ensure the integration of quality and compliance activities into all levels of the organization. Ensure risk management, patient safety, and compliance data are integrated into QI reporting. Maintain documentation for accreditation readiness (Joint Commission, CMS, BSAS, DMH), including Measures of Success, FMEAs, and audit tools. Coordinate and lead Quality and Compliance Committees, and co-lead Patient Safety Committee. May co-lead other committees as assigned. Regulatory & Accreditation Compliance Ensure ongoing readiness for TJC, DMH, BSAS, and CMS surveys and inspections. Serve as primary liaison during all regulatory surveys, audits, and inspections. Monitor changes in laws, regulations, and standards, and update hospital policies and practices accordingly. Performance Measurement & Reporting Collect, analyze, and report data related to clinical outcomes, patient safety, and performance indicators. Conduct root cause analyses, identify trends, and facilitate corrective action planning. Provide regular quality and compliance reports to hospital leadership and the Governing Body. Education & Training Develop and deliver staff education on quality improvement, patient safety, and compliance standards. Support department leaders in understanding and applying regulatory and accreditation requirements. Risk Management & Incident Oversight Oversee the hospital's incident reporting, investigation, and follow-up processes. Ensure timely reporting to regulatory agencies when required. Collaborate with leadership on risk reduction strategies. Policy Development & Review Maintain and review hospital policies and procedures for regulatory alignment. Ensure timely policy updates and staff notification. Communication Demonstrates professionalism, clarity, and respect in all forms of communication. Communicate effectively with staff, leadership, patients, and regulatory agencies. Maintains open, collaborative communication across departments to support transparency and teamwork. Demonstrates appropriate communication and composure in challenging or high-pressure situations, including when addressing compliance findings, staff concerns, or regulatory interactions. Provides constructive feedback and education to staff in a supportive and solution-focused manner. Ensures communication of quality and compliance data is accurate, timely, and easily understood by diverse audiences. Key Performance Indicators (KPIs) 100% of required regulatory reports submitted within mandated timelines. 100% of policies reviewed and updated per scheduled cycle. No Condition-level findings during regulatory surveys. 90% of incident reports investigated and closed within set timeframe. Evidence of ongoing performance improvement initiatives documented in QAPI reports. Compliance Responsibility Adheres to all hospital policies and procedures. Ensures compliance with all applicable standards, including TJC, DMH, BSAS, and CMS. Maintains confidentiality in accordance with HIPAA and hospital standards. Reports any suspected violations of compliance or safety standards immediately. May act as Privacy Officer and assist in HRO complaint resolutions. Competencies Knowledge of behavioral health care delivery systems. Commitment to ethical practice and patient rights. Ability to work collaboratively across interdisciplinary teams. Strong problem-solving, decision-making, and leadership skills. Capacity to manage confidential information with discretion. Qualifications Licensure: Current Massachusetts licensure as a Registered Nurse (RN), Licensed Practical Nurse (LPN), or Licensed Independent Clinical Social Worker (LICSW) required. Education: Bachelor's degree in Nursing, Social Work, Health Care Administration, or related field required; Master's degree preferred. Experience: Minimum of three (3) years of progressive experience in quality management, regulatory compliance, or performance improvement in a healthcare setting. Experience in psychiatric or behavioral health strongly preferred. Knowledge/Skills: Comprehensive knowledge of The Joint Commission (TJC), Massachusetts Department of Mental Health (DMH), Bureau of Substance Addiction Services (BSAS), and Centers for Medicare & Medicaid Services (CMS) standards and reporting requirements. Strong analytical, organizational, and project management skills. Ability to interpret regulations and accreditation standards and translate them into practice. Excellent written, verbal, and interpersonal communication skills. Proficiency in Microsoft Office Suite and data reporting systems.
    $115k-125k yearly 51d ago
  • SAP Quality Management/Manufacturing Manager - Chemicals Industry

    Accenture 4.7company rating

    Quality assurance manager job in Boston, MA

    We Are: Are you ready to step into the heart of digital transformation in one of the world's most critical - and most dynamic - industries? The Chemicals Industry is evolving at lightspeed: demand for sustainability-driven products is on the rise. At the same time, digital platforms, real-time analytics, AI, and SAP-enabled processes are no longer "nice to have" - they are foundational. As part of Accenture's SAP Chemical's Practice, you'll be delivering major SAP engagements (for example, Business Transformation Strategy & Roadmaps, migrations to SAP S/4HANA, process standardization, cloud-enablement) that help clients win in this new environment and guide major Chemical clients through the journey of business-model reinvention, process excellence and enterprise technology enablement You Are: Do you have a passion for storytelling and for originating, selling and delivering SAP-based Supply Chain Transformation projects that make a positive impact in your clients' business? Are you inspired by working with the best companies in their industries? Want a role that provides you with a sense of purpose and satisfaction? Then join Accenture and build a rewarding career improving the way the world works and lives, as you help clients innovate with leading-edge SAP and Accenture Supply Chain solutions and technologies on some of the most innovative projects in the world You will thrive in our highly collaborative, digitally-driven and innovation-led environment while nurturing your talent for thoughtful and game changing solutions in our inclusive culture that values diversity of ideas, experiences and backgrounds. Ultimately, you are a confident manager who spots and stays ahead of the SAP platform, industry and Supply Chain trends and knows how to translate client goals into clear and actionable outcomes that everyone can get behind. You know how to fully utilize the capabilities of various SAP platforms to drive business value, transform end-to-end functions and drive leading practices for your clients in markets all over the globe. The more complex their challenges, the more excited you are about leading the charge to solve them. The Work: Team with clients on their SAP functional transformation programs through your combined SAP application and functional process expertise which includes your ability to: + Engage with client executives on the business challenges/trends and the potential value of SAP solutions (current & future) + Lead customers in defining their SAP journey through the development of business cases & roadmaps including during sales origination, proposal development and client presentations + Architect E2E solutions that leverage SAP technologies, custom apps, & add on partner solutions + Advise, design and deliver solutions based on the latest industry and technology best practices leveraging a SAP solutions and embedded innovation. + Lead small teams - helping them achieve transformational roadmaps - onsite with clients or within Accenture + Become a trusted expert and advisor to your clients, team, and Accenture Leadership by staying current on regulations, trends, and innovations across your area of expertise + Be a thought leader, build assets and best practices and develop the next level of transformation experts Travel may be required for this role. The amount of travel will vary from 0 to 100% depending on business need and client requirements Here's what you need: + Minimum of 5 years of SAP functional and technical experience/expertise in Quality Management and/or Manufacturing. + Minimum 3 years of experience in SAP projects supporting Chemicals clients. (SAP support / managed services experience will not be considered for this requirement) + Minimum 2 end-to-end SAP S/4 implementations, including project planning, estimation and solution architecture for Chemicals clients + Experience managing SAP delivery teams, in a Global Delivery Model, including but not limited to the following responsibilities: driving complex workshops and leading design decisions, as well as leading the design and execution of system build, configuration, testing, cutover, and go-live in the SAP Transportation Management or Quality Management area + Prior experience in a Consulting and/or Advisory role + Bachelor's degree or equivalent (minimum 12 years' work experience). If Associate's Degree, must have equivalent minimum 6-year work experience Compensation at Accenture varies depending on a wide array of factors, which may include but are not limited to the specific office location, role, skill set, and level of experience. As required by local law, Accenture provides a reasonable range of compensation for roles that may be hired as set forth below. We accept applications on an on-going basis and there is no fixed deadline to apply. Information on benefits is here. (************************************************************ Role Location Annual Salary Range California $94,400 to $293,800 Cleveland $87,400 to $235,000 Colorado $94,400 to $253,800 District of Columbia $100,500 to $270,300 Illinois $87,400 to $253,800 Maryland $94,400 to $253,800 Massachusetts $94,400 to $270,300 Minnesota $94,400 to $253,800 New York/New Jersey $87,400 to $293,800 Washington $100,500 to $270,300 Requesting an Accommodation Accenture is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Accenture and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired. If you would like to be considered for employment opportunities with Accenture and have accommodation needs such as for a disability or religious observance, please call us toll free at **************** or send us an email or speak with your recruiter. Equal Employment Opportunity Statement We believe that no one should be discriminated against because of their differences. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities. For details, view a copy of the Accenture Equal Opportunity Statement (******************************************************************************************************************************************** Accenture is an EEO and Affirmative Action Employer of Veterans/Individuals with Disabilities. Accenture is committed to providing veteran employment opportunities to our service men and women. Other Employment Statements Applicants for employment in the US must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States. Candidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration. Job candidates will not be obligated to disclose sealed or expunged records of conviction or arrest as part of the hiring process. Further, at Accenture a criminal conviction history is not an absolute bar to employment. The Company will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. Additionally, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the Company's legal duty to furnish information. California requires additional notifications for applicants and employees. If you are a California resident, live in or plan to work from Los Angeles County upon being hired for this position, please click here for additional important information. Please read Accenture's Recruiting and Hiring Statement for more information on how we process your data during the Recruiting and Hiring process.
    $100.5k-270.3k yearly 17d ago
  • Director of QA

    Intralinks 4.7company rating

    Quality assurance manager job in Boston, MA

    As a leading financial services and healthcare technology company based on revenue, SS&C is headquartered in Windsor, Connecticut, and has 27,000+ employees in 35 countries. Some 20,000 financial services and healthcare organizations, from the world's largest companies to small and mid-market firms, rely on SS&C for expertise, scale, and technology. Job Description Job Title: Director of QA Locations: Boston, MA or Windsor, CT | Hybrid Get To Know Us: We are a fast-paced, dynamic team, who are leaders in technology and responsible for developing, maintaining, implementing, and expanding our next-generation platform for insurance companies. Singularity is a cloud-based, AI-powered platform for insurers and investment managers that provides integrated accounting, operational processing, and advanced analytics for all asset types. Why You Will Love It Here! Flexibility: Hybrid Work Model and Business Casual Dress Code, including jeans Your Future: 401 (k) Matching Program, Professional Development Reimbursement Work/Life Balance: Flexible Personal/Vacation Time Off, Sick Leave, Paid Holidays Your Wellbeing: Medical, Dental, Vision, Employee Assistance Program, Parental Leave Wide Ranging Perspectives: Committed to Celebrating the Variety of Backgrounds, Talents, and Experiences of Our Employees Training: Hands-On, Team-Customized, including SS&C University Extra Perks: Discounts on fitness clubs, travel, and more! What You Will Get To Do: The Director of QA is responsible for defining and executing a consistent and repeatable process for full product testing, deployment, and release for Insurance software solutions. The Director must have strong leadership and planning skills and be able to manage both large and small projects through an iterative lifecycle model. Ensures that products meet end-user functional and design requirements as well as performance and scale expectations through the execution of software quality tests. Defines and executes integration, performance, regression, and/or acceptance testing. Develops and supports the test automation environment for executing software quality tests. Leader with broad operational or functional responsibilities who participates with other senior leaders or executives to establish and ensure the achievement of strategic plans and objectives. Demonstrates in-depth company knowledge, specialized skills, and influence to solve critical and complex issues. Participates in the development and administration of broad-scope programs and projects that have a significant impact on operational or functional success. The Director will manage a team across multiple locations and will be responsible for defining and executing the test strategy, maintaining a build environment throughout the iterative development cycle, and building the final release of the product to deliver to market. The incumbent for this role will: • Define and maintain project plans to manage delivery schedule, resource management, task tracking, and status reporting through testing and release phases of projects • Define and execute a consistent, repeatable process for QA • Maintain an efficient, high-quality library of scripts for automated testing • Deliver a clear release-to-market certificate for all product releases • Maintain reliable infrastructure to support source control, build, and release environment • Deliver a reliable and repeatable deployment model for all products • Manage day-to-day task assignment and team member workload • Manage progress and status for a cross-functional team across multiple projects • Establish SMART goals and career development for team members and review/reset as necessary What You Will Bring: Candidates must have led product QA organizations with oversight over the parts of the software development process that involve QA testing and release readiness, and have experience with SaaS software applications in the financial services sector. 10-15 years of experience in the financial industry 10 years in a QA leadership position A candidate should have extensive experience implementing the testing and QA approach as applied to a business or a product Candidate must have planning and presentation skills The Candidate must have strong leadership abilities and the ability to provide direction Education: B.A. or B.S. required Thank you for your interest in SS&C! If applicable, to further explore this opportunity, please apply directly with us through our Careers page on our corporate website @ ************************ Salary range for the Position is expected between $150,000.00 and $175,000.00. The successful candidate may be eligible for an annual discretionary incentive compensation award. #LI-DS3 #LI-HYBRID Unless explicitly requested or approached by SS&C Technologies, Inc. or any of its affiliated companies, the company will not accept unsolicited resumes from headhunters, recruitment agencies, or fee-based recruitment services. SS&C offers excellent benefits including health, dental, 401k plan, tuition and professional development reimbursement plan. SS&C Technologies is an Equal Employment Opportunity employer and does not discriminate against any applicant for employment or employee on the basis of race, color, religious creed, gender, age, marital status, sexual orientation, national origin, disability, veteran status or any other classification protected by applicable discrimination laws.
    $150k-175k yearly Auto-Apply 13d ago
  • QC Manager, Bioanalytical

    Invitrogen Holdings

    Quality assurance manager job in Plainville, MA

    As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Location/Division Specific Information Reporting to the Plainville, MA site and supporting the Viral Vector Services (VVS), a division of Thermo Fisher Scientific. At VVS, we deliver from process development through commercial supply, offering the expertise and resources vital to help clients deliver innovative gene therapies. We are placed at the forefront of our leading and groundbreaking Cell and Gene Therapy business, enabling clients to cure genetic, rare, and otherwise untreatable diseases. Discover Impactful Work: The Manager, Quality Control Bioanalytical & Analytical Transfer provides leadership and scientific and technical expertise for bioanalytical QC and transfer activities at the Plainville, Massachusetts site. These activities include the timely qualification of in-process and release testing of toxicological, clinical, and commercial grade biopharmaceuticals, qualification/validation of analytical methods for support of cGMP manufacturing, and the transfer and validation of assay methods from clients and/or Assay Development & Analytics to the cGMP QC testing laboratory. The manager ensures cGMP compliance, operates within budgets, and supervises bioanalytical lab staff directly and QC scientists and technicians indirectly. Responsibilities include hiring, training, goal setting, and performance evaluation. The manager collaborates with departments and project teams for planning and timelines, improves QC services, and maintains safe working conditions. Additionally, the manager serves as the primary technical liaison with clients. A Day in the Life: Lead all aspects of and drive the Bioanalytical lab operational readiness plan to ensure on-time approval of analytical equipment and test methods needed for GMP testing. Build a trained, competent team of QC analysts to support GMP testing. Coordinate daily Quality Control activities for Molecular, Viral, Cell, and Tissue Culture operations and contract testing. Ensure compliance, accuracy, and timeliness of testing processes. Lead the introduction of new technology, equipment, methodologies, and validations. Provide QC leadership and support across the VVS organization. Facilitate cross-functional communication and ensure all testing processes, metrics, and departmental goals are achieved. Strive to implement and improve systems and drive efficiency throughout the organization. Support internal, external, and regulatory inspections as needed. Hire and develop employees within the department. Assign work, coach staff, and take vital disciplinary actions. Serve as primary QC Bioanalytical contact for regulatory inspections and client audits. Provide support for method qualification and validation from Assay Development and Analytics and/or clients. Support the establishment and/or enhancement of QC and operational metrics. Provide frequent overall departmental feedback to senior management. Ensure adequate staffing is hired and trained. Keys to Success:Education BS required, MS preferred in a scientific/technical field. PhD in a scientific/technical field is a plus. Experience 6-8 years of experience in a quality position within the biological and/or pharmaceutical industry required. Significant experience in supporting functional areas (e.g., PD, Manufacturing, QA, Engineering, EHS) preferred. Experience with writing Deviations, Lab investigations, and OOS required; experience with Root Cause Analysis required. 2-3 years experience leading teams in a fast-paced environment required. Experience with regulatory inspections from the FDA, EMA, Health Canada, or other regulatory authorities required. Knowledge, Skills, Abilities Capable of writing reports, business correspondence, and procedure manuals. Strong organizational skills; ability to prioritize and lead through complex processes/projects. Ability to read, analyze, and interpret business periodicals, common scientific, professional, and technical journals, financial reports, governmental regulations, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to employees, top management, public groups, and/or boards of directors. Ability to interpret and carry out an extensive variety of technical instructions in written, oral, schedule, mathematical, or diagram form. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to apply principles of logic or scientific thinking to a wide range of intellectual and practical problems. Able to lead abstract and concrete variables in situations where only limited standardization exists. Benefits We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.
    $85k-124k yearly est. Auto-Apply 60d+ ago
  • Quality Assurance Specialist II, Manufacturing Quality Assurance (Fri - Mon)

    Nitto Denko 4.2company rating

    Quality assurance manager job in Milford, MA

    About this opportunity : The Quality Assurance Specialist, Manufacturing Quality Assurance is responsible for overseeing manufacturing batches and operational support activities that are on-going daily. This is a first shift position (Fri-Mon) and comes with a 10% shift differential. Key Responsibilities: Executes daily line clearance and oversees manufacturing activities by utilizing general area QA oversight checklists. Assist with production and QC to provide Good Manufacturing and Laboratory Practices. Understand and execute MQA responsibilities that are defined in SOP. Monitoring manufacturing operations including cleaning by conducting reviews of logbooks. Escalate detected major issues on the floor to MQA and QA management. Review facility cleaning, material transfers and personnel hygiene control. Providing quality oversight to critical building management system (BMS) alarms, preventive maintenance (reactive work orders), and calibration (out of tolerance). Based on outcomes of QMRs, quality council, internal and external audit findings, and QA operational (e.g., MQA) findings identify, propose and lead continuous improvement projects. Provide Quality oversight and compliance guidance on new building program initiatives. Train, motivate, monitor, and lead quality teams through necessary change. Required Skills/Abilities: At least 3 years' experience in a regulated/GMP industry required, with experience in Pharmaceuticals or Biotechnology preferred. Understanding of 21 CFR 210, 21 CFR 211, and ICH Q7 regulations. Ability to work in a fast-paced environment consisting of internal and external team members with minimal oversight. Problem-solving skills with the ability to adapt to changing priorities and timelines. Ability to build positive working partnerships with other department teams. Experienced in the use of electronic systems such as eQMS. Prior experience with clinical and commercial manufacturing is preferred. Requires the ability to gown into clean rooms and wear PPE. The annualized salary range for this role is $67,900.00 - $83,100.00
    $67.9k-83.1k yearly 11d ago
  • Program Manager - Clinical Quality Management (Infectious Disease Bureau)

    Internships.com 4.1company rating

    Quality assurance manager job in Boston, MA

    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
    $101k-135k yearly est. 16h ago
  • Supplier Quality Manager

    Pharmaron 4.5company rating

    Quality assurance manager job in Coventry, RI

    Supplier Quality Manager FLSA Status: Exempt Are you ready to embark on an exhilarating journey with a team that's passionate about making a difference? Pharmaron is thrilled to invite you to join us as our newest Supplier Quality Manager at our Coventry, RI facility! If you're craving a role that offers challenges, growth, and meaningful impact, then this is the opportunity you've been waiting for. Job Overview: Pharmaron's Coventry site is seeking an experienced Supplier Quality Manager to lead QA activities related to suppliers, materials, receiving, and warehousing. This role also provides support for QA functions in manufacturing and equipment qualification. This is an excellent opportunity for a self-motivated and driven professional to contribute to a dynamic and growing organisation within the pharmaceutical sector. What You'll Be Doing: Supplier Qualification & Management Maintain the site's supplier and service provider qualification programme, including contract labs Act as QA point of contact for supplier deviations and corrective actions Manage quality agreements and maintain Approved Supplier Lists Review and document supplier change notices Ensure supplier documentation is up to date Host the Vendor Assurance Committee and lead QA assessments for new materials and suppliers Write and assess material specifications and vendor assurance reports Perform risk assessments and collaborate with development teams on use test requirements Auditing & Inspections Conduct supplier audits Support internal audits, client audits, and regulatory inspections Quality Systems & Projects Lead cross-functional teams for major investigations using site tools Ensure procedures are phase-appropriate for clinical Phase 1 through commercial API manufacturing Contribute to the implementation of an ERP system for warehouse and procurement systems Manufacturing & Equipment Qualification Coordinate product release activities including batch record review and analytical data receipt Support equipment cleaning and qualification processes Client Development Support Assist with client quality agreements Help develop and track Key Performance Indicators (KPIs) with clients What We're Looking For: A Bachelor's degree in Chemistry, Engineering, or a related scientific discipline Minimum 6 years of QA experience in a CMO/CDMO environment focused on API manufacturing Strong understanding of phase-appropriate quality systems (from clinical Phase 1 through commercial API) Experience in regulatory and client interactions, including inspections and audits Proven ability to host audits and support regulatory inspections Solid knowledge of ICH guidelines (especially ICH Q7) and CFR regulations Familiarity with ERP systems and Quality Management Systems such as TrackWise Excellent communication and collaboration skills Why Pharmaron? Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 21,000 employees and operations in the U.S., the U.K. and China. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China. Collaborative Culture: You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators. Benefits: As part of our commitment to your well-being, we offer a comprehensive benefits package: Insurance including Medical, Dental & Vision with significant employer contributions Employer-funded Health Reimbursement Account Healthcare & Dependent Care Flexible Spending Accounts 100% Employer-paid Employee Life and AD&D Insurance, Short and Long Term Disability Insurance 401k plan with generous employer match Access to an Employee Assistance Program How to Apply: Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today! As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.
    $87k-111k yearly est. 60d+ ago
  • Construction Quality Control Manager

    Big League Talent Connection

    Quality assurance manager job in Newport, RI

    Interested in an outstanding opportunity to become part of a team with a stellar reputation as a community engaged Employer of Choice? Established well over a century ago, the Company has grown over the last 100-plus years from a local fourth generation family business into one of the largest construction managers and general contractors in the Northeast and Mid-Atlantic regions. In 2018, we transitioned to 100-percent employee-ownership. Nationally ranked as one of Forbes Best Midsize Employers in 2021 and 2022 and as one of the Best Places to Work by the Boston Globe, the Washington Post, the Hartford Business Journal, and MaineBiz, our culture draws raw talent from college interns to seasoned veterans with substantial years of experience in their field. We credit empowerment, innovation and “thinking great” for our continual growth and success. Most important, we are thankful for our employees and are proud to have one of the most exciting project portfolios in the business. Quality Control Manager Formulate and maintain quality control objectives, coordinating them with production procedures, ensuring product reliability and cost minimization. The Quality Control Manager will play an integral role during all phases of a project, beginning in pre-construction and ending with project close-out. During the pre-construction phase, the individual will review all contract quality language and coordinate constructability with the owner and architect(s). During the construction of a project, work with teams to track and measure quality data for performed work, coordinate quality efforts with subcontractors, and be a resource for any quality-related issues on-site. Additional responsibilities include conducting inspections and walkthroughs for close-out, setting and maintaining company policies relating to quality, and participating in business development activities, when applicable. Required Skills Pre-Construction Help with proposals, attend selected interviews Review selected supplemental instructions/specs for completeness Review contract quality language Constructability review on selected projects or pre-cons, coordinate with architect Set and maintain company policy The preparation of the companies QA manual control and supervision of all amendments and revisions Update policy as required Hold preconstruction meeting with team and develop site specific plan, include specifically who is doing each task Review and improve 100% material verification policy Manage Program as work progresses Insure testing log set up prior to start of work, help coordinate outside testing Attend pre-ops on selected projects: private projects, self-perform operations, finish sensitive projects Act as resource for specific quality related issues Help manage subcontractor quality efforts, develop methods to encourage subs to plan Help insure selected operations proceed according to plans and specifications Meet with client on selected projects to review quality expectations and concerns Review deficiency logs, monitor items completed on a timely basis Insure we are following material verification policy Measurement and communication Make sure paperwork gets done Audit paperwork. Rate paperwork Communicate results to teams Manage QIHTU, send out weekly message like tool box talks, post on intranet Review pre op minutes and post samples on intranet Recognize and communicate common deficient items including methods to avoid Close out/post close out Keep statistics on call backs Focus on call back issues - water and air infiltration, hvac Conduct pre-punch inspection on selected projects Perform warranty walk-throughs, compile statistics, distribute lessons learned Required Experience High School degree with applicable experience or Bachelor's Degree in Construction Management, Engineering, or related area of specialty required; 5-10 years' experience in the construction field or in a related area required; Thorough knowledge of the construction field's concepts, practices, and procedures required; An Affirmative Action / Equal Opportunity Employer Company provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
    $73k-107k yearly est. 60d+ ago
  • Biomedical Education QA Engineering Coordinator

    Brigham and Women's Hospital 4.6company rating

    Quality assurance manager job in Boston, MA

    Site: The Brigham and Women's Hospital, 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 Summary Responsible for building, providing, coordinating, and, facilitating comprehensive training and education on the use, maintenance, and troubleshooting of biomedical equipment to BME technical staff. Does this position require Patient Care? No Essential Functions * Develop, deliver, coordinate, and facilitate training programs on the use and maintenance of biomedical equipment, including but not limited to diagnostic, therapeutic, and monitoring devices. * Develop and update training materials, user guides, and standard operating procedures (SOPs) for various biomedical devices and technologies. Ensure training programs are aligned with the latest industry standards, safety regulations, and healthcare protocols. * Provide and facilitate practical, hands-on training sessions, demonstrating how to properly set up, operate, and troubleshoot biomedical equipment. Ensure participants achieve competency in equipment use to enhance patient outcomes. * Stays up to date on new technologies, product updates, and advancements in biomedical engineering. * Ensure that all training content adheres to healthcare regulations, safety standards, and compliance guidelines (e.g., FDA, OSHA). * Evaluate the effectiveness of training programs through assessments, feedback, and observation. Identify areas for improvement and adjust training programs to ensure participants meet required proficiency levels. * Work closely with biomedical engineering teams, medical device manufacturers, and technical staff to ensure smooth integration of biomedical equipment into healthcare operations. Qualifications Education Bachelor's Degree Biomedical Engineering required or Bachelor's Degree Related Field of Study required Can this role accept experience in lieu of a degree? Yes Licenses and Credentials Experience Experience in biomedical equipment or other closely related role 3-5 years required and Experience in training, staff development, or other related role 1-2 years preferred Knowledge, Skills and Abilities * Strong technical understanding of biomedical equipment, such as diagnostics, patient monitoring, and therapeutic devices. * Excellent communication and presentation skills, with the ability to convey complex technical concepts to non-technical audiences. * Proficiency in Microsoft Office Suite (PowerPoint, Word) and familiarity with training software or learning management systems (LMS). * Problem-solving skills with an ability to troubleshoot and resolve technical issues in real time during training sessions. Additional Job Details (if applicable) Physical Requirements * Standing Frequently (34-66%) * Walking Frequently (34-66%) * Sitting Occasionally (3-33%) * Lifting Frequently (34-66%) * Carrying Frequently (34-66%) * Pushing Occasionally (3-33%) * Pulling Occasionally (3-33%) * Climbing Rarely (Less than 2%) * Balancing Frequently (34-66%) * Stooping Occasionally (3-33%) * Kneeling Occasionally (3-33%) * Crouching Occasionally (3-33%) * Crawling Rarely (Less than 2%) * Reaching Frequently (34-66%) * Gross Manipulation (Handling) Frequently (34-66%) * Fine Manipulation (Fingering) Frequently (34-66%) * Feeling Constantly (67-100%) * Foot Use Rarely (Less than 2%) * Vision - Far Constantly (67-100%) * Vision - Near Constantly (67-100%) * Talking Constantly (67-100%) * Hearing Constantly (67-100%) Remote Type Hybrid Work Location 100 Blossom Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $92,102.40 - $134,056.00/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: The Brigham and Women's Hospital, 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.
    $92.1k-134.1k yearly Auto-Apply 30d ago
  • Construction Quality Control Manager

    J.R. Vinagro Corporation

    Quality assurance manager job in Johnston, RI

    General Description: The Construction Quality Control Manager (“CQCM”) is responsible to develop and oversee and support field-based quality efforts for all JR Vinagro construction projects. CQCM provides support by reviewing specifications and developing project specific quality plans, inspection and test plans, providing guidance on quality questions, assisting with quality audits, and attending project meetings. The Regional Quality Manager provides oversight for JRV project field staff and third-party quality and/or inspection personnel. This role reports to the Vice President of Construction and interacts with stakeholders within Project Management, Estimating, Business Development, Field Operations, clients, consultants, and vendors. Core Responsibilities Develop and implement a comprehensive field quality management system across all projects. Guide field staff on quality standards to drive compliance with industry and contract requirements. Work VP of Construction and Construction Manger to enhance company quality documentation. Provide Quality Control training for Project Team members. Work collaboratively with Project Management team to draft detailed Project Specific Quality Plans, Inspection and Test Plans, and Quality Checklists. Ensure methods and procedures for recording, evaluating, and reporting quality and reliability data are followed and executed by field staff. Interface with Owners to clarify acceptability of project quality plans and assist with identification of quality incident solutions, RFI responses, and NCR responses. Identify Critical Quality Control activities that may impact the project and critical path. Visit project sites and develop observation reports to identify quality issues pertaining to document control and any gaps in program adherence. Proactively identify and report issues of noncompliance and work with management to educate and remediate. Qualifications BA in engineering or related discipline or equivalent work experience in the construction industry with specific quality control experience 5-10 years as construction quality control manager or representative Must be detail-oriented, organized, flexible, and able to effectively multitask while working in a fast-paced environment. Excellent time management and prioritization skills to ensure deadlines are met while providing accurate deliverables. Strong working knowledge of Microsoft Office (Excel, Word, Power Point, and Outlook) Preferred Qualifications Strong understanding of Quality Control and Assurance practices for Civil Infrastructure / DOT and Airport construction projects. OSHA 30 Certification ASQ Quality Inspector, NETTCP Certification, Concrete ACI Certification or other professional certifications. Strong field construction experience - successful candidates will understand construction sequencing, durations, dependencies, production, and the time and cost implications of failures. Background knowledge of construction industry QA/QC practices and standards. Benefits Competitive base salary, commensurate with experience Vehicle / transportation allowance healthcare plus dental & vision. 401k plus company match up to 5%. JR Vinagro is an equal opportunity employer
    $73k-106k yearly est. Auto-Apply 49d ago
  • QC Manager

    Neurotech U S A

    Quality assurance manager job in Cumberland, RI

    Job Description Neurotech Pharmaceuticals, Inc. is a private biotech company located in Cumberland, RI and Needham, MA, within the realm of Greater Boston's vast biotechnology landscape. Since our inception more than 20 years ago, our focus has been on developing and commercializing transformative therapies for chronic eye diseases. The core platform technology, Encapsulated Cell Therapy (ECT), is a first-in-class drug delivery platform designed to slow the progression of chronic eye diseases. Neurotech's first commercial product, ENCELTOTM (revakinagene taroretcel-lwey), is approved in the United States for the treatment of adults with idiopathic Macular Telangiectasia Type 2 (MacTel). Encapsulated cell-based gene therapy is designed to provide long-term, sustained delivery of therapeutic proteins for the treatment of chronic eye diseases. The Manager, Quality Control Microbiology & Environmental Monitoring (EM), is responsible for leading all microbiological quality control programs at Neurotech, including oversight of environmental monitoring, sterility assurance, endotoxins, and mycoplasma testing programs. While certain compendial assays are performed by external contract laboratories, this position ensures method oversight, data review, and vendor compliance with GMP requirements. This role serves as the site subject matter expert (SME) for microbiology and contamination control and provides strategic and technical leadership across multiple product streams. The Manager will mentor and develop a growing Microbiology team, ensuring operational excellence, inspection readiness, and the highest standards of data integrity and GMP compliance in support of Neurotech's clinical and commercial manufacturing operations. Job Requirements Lead and oversee the Environmental Monitoring (EM) program, including viable and non-viable particulate monitoring, surface sampling, personnel monitoring, utility gases, purified water, and trending/reporting of results. Manage internal Microbiology laboratory operations, ensuring GMP compliance, data integrity, and timely execution of testing to support manufacturing and release activities. Serve as SME for microbiology, sterility assurance, and contamination control across Neurotech manufacturing and support areas. Provide oversight and technical review for outsourced compendial testing (e.g., bioburden, Microbial IDs, dose audits, mycoplasma, etc.) performed by contract testing organizations (CTOs). Develop and maintain microbiological control strategies for aseptic processing areas, including management of EM limits, deviation investigations, and contamination trend analyses. Author, review, and approve technical documentation, including SOPs, EM plans, protocols, and technical reports. Support site audits and regulatory inspections/responses as the primary Microbiology & EM representative. Partner cross-functionally with Manufacturing, Facilities, and Quality Assurance to maintain a robust contamination control program. Provide mentorship, coaching, and daily leadership to Microbiology & EM analysts; establish training and competency plans for the team. Participate in risk assessments, root cause analyses, and CAPA development related to microbiological or environmental events. Support site efforts through timely design, validation, and execution of studies, protocols, reports, etc. Identify and drive continuous improvement initiatives to enhance testing efficiency, data integrity, and contamination control systems. Education & Experience Bachelor's or Master's degree in Microbiology, Biology, Biotechnology, or related life science. 8-12 years of progressive experience in GMP Quality Control Microbiology, including direct experience managing Environmental Monitoring programs. Strong working knowledge of compendial microbiological methods (e.g., USP , , , , , , , , etc.), aseptic techniques, and contamination control principles. Demonstrated experience leading or overseeing Microbiological testing (e.g., sterility, endotoxins, mycoplasma, etc.). Proven track record in team leadership, mentorship, and technical development of laboratory staff. Comprehensive understanding of GMPs (21 CFR 210/211/820/ISO 13485), aseptic manufacturing, and cleanroom behavior. Excellent written, verbal, and interpersonal communication skills with the ability to interact effectively across departments. Prior experience supporting biologics, cell therapy, or gene therapy manufacturing strongly preferred. Knowledge, Skills & Abilities Technical and Regulatory Expertise in Microbiology & EM Leadership and Team Mentorship Data Integrity and GMP Documentation Excellence Contamination Control Strategy and Risk Assessment Continuous Improvement and Problem-Solving Orientation Do you share our vision? Applications are currently being accepted through the Neurotech Career Center. Neurotech Pharmaceuticals provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
    $73k-106k yearly est. 16d ago

Learn more about quality assurance manager jobs

How much does a quality assurance manager earn in New Bedford, MA?

The average quality assurance manager in New Bedford, MA earns between $72,000 and $149,000 annually. This compares to the national average quality assurance manager range of $70,000 to $140,000.

Average quality assurance manager salary in New Bedford, MA

$103,000
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