41 quality systems specialist jobs at 26 companies in Acton, MA
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Principal Quality Systems Specialist
Northridge or California or Seattle or Washington or Boston or New York City or Los Angeles County or United States
$121k-$205k/yrOnsiteFull Time
MiniMed GroupNasdaq: MMED: A medical device developing insulin delivery systems and connected care solutions for people living with diabetes.
5+ YOEBaccalaureate degree with 7+ years (or advanced degree with 5+ years) in quality systems; experience with QMS, Change Management, CAPA, audits, and Microsoft Office; strong communication and prioritization skills.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Agile, Trackwise, Microsoft Teams, Microsoft Project, Power BI
eGenesis: Developing genetically engineered animal organs for human transplantation.
5+ YOEBachelor’s degree in life sciences or biopharma with 5+ years of quality systems experience, or 7+ years relevant GLP/GMP experience without a degree; QMS, CAPA, audit, regulatory, analytical, and communication skills required.
ABCorp: Produces secure payment cards and provides additive manufacturing solutions.
5+ YOE5+ years in quality assurance/systems in regulated manufacturing; experience with CAPA, deviations, investigations, change and document control, audits, SOPs, root cause analysis, QMS/ERP, and strong written documentation and cross-functional collaboration.
Fresenius Medical CareNew York Stock Exchange: FMS: Provides dialysis services and manufactures renal care medical devices
6+ YOEBachelor's degree, 6+ years related experience, deep knowledge of quality systems, recalls/corrections & removals, regulatory requirements (US, Health Canada, Mexico), Microsoft Access/Outlook/ERP skills, audit and training experience.
Microsoft Access, Microsoft Outlook, ERP software, Microsoft Office
Kymera TherapeuticsNASDAQ: KYMR: Develops targeted protein degradation medicines to treat human diseases.
5+ YOEBachelor's in life sciences, 5+ years quality systems/GxP/document control experience in a sponsor organization, hands-on eQMS administration, GxP training program management, knowledge of 21 CFR Part 11 and ICH E6(R3).
Veeva Vault, Microsoft Word, Microsoft Excel, Microsoft PowerPoint
WHOOP: Wearable technology for personalized health and performance tracking.
2+ YOEBachelor's in engineering or life sciences,2+ years QMS/QA experience in medical device or digital health,working knowledge of ISO 13485 and 21 CFR Part 820,QMS processes (CAPA,complaints,audits),and eQMS experience.
HexcelNYSE: HXL: Produces advanced composite materials for aerospace and industrial applications.
HS/GED required; proficiency with Microsoft Office; experience supporting CMMS, LMS, DMS, NCM/CAPA and calibration databases; records management, report generation, strong written and verbal communication; U.S. citizenship required.
CMMS, LMS, DMS, NCM, CAPA, Microsoft Word, Microsoft Outlook, Microsoft Excel, Microsoft PowerPoint
Merck KGaA, Darmstadt, GermanyFrankfurt Stock Exchange: MRK: A science and technology in healthcare, life sciences, and electronics.
2+ YOEBachelor's degree and 2+ years of quality management systems experience plus 1+ year of QA experience. Knowledge of ISO 9001, auditing, communication, organization, and time management preferred.
MerckXETRA: MRK: A science and technology providing healthcare, life science, and electronics solutions.
2+ YOEBachelor's degree, 2+ years of Quality Management Systems experience, 1+ year of QA experience, and knowledge of ISO 9001-based systems. Pharmaceutical and auditing experience preferred.
Quality Management System (QMS), ISO 9001, Key Quality Indicators (KQIs), Integrated Management Reviews
Johnson & JohnsonNYSE: JNJ: Provides pharmaceutical products and medical technology healthcare solutions.
6+ YOEBachelor’s degree and 6+ years in quality, analytics, compliance, or related regulated-industry roles. Requires dashboard development, quality systems experience, data analysis, audit support, and English proficiency.
Power BI, ISO 13485, ISO 9001, Standard Operating Procedure (SOP)
EmersonNYSE: EMR: Engineering industrial automation and software solutions for global industries.
High school diploma/GED, exceptional attention to detail, process-oriented, proficiency in Microsoft Word and Excel, familiarity with ASME and Oracle systems preferred, legal US work authorization required.
Boston ScientificNYSE: BSX: Developing and manufacturing innovative medical devices for less-invasive treatments.
3+ YOEBachelor's in science/health/engineering, 3+ years with quality systems and controlled processes, ability to travel up to 30%, knowledge of GCP/ISO 14155 preferred, audit experience and quality certifications preferred.
Boston ScientificNYSE: BSX: Manufacturer of interventional medical devices and technologies.
3+ YOEBachelor's degree in science/health/engineering, minimum 3 years with quality systems and controlled processes, ability to travel up to 30%, knowledge of GCP/ISO 14155 preferred, auditing and quality certification experience preferred.
Boston ScientificNYSE: BSX: Developer and manufacturer of innovative medical devices and therapies.
5+ YOEBachelor's degree, 5+ years clinical QA experience including GCP audits, working knowledge of ISO 14155/13485/GCP/GMP/GDP, CAPA and quality systems experience, ability to travel up to 30%.
ISO 14155, ISO 13485, Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Documentation Practice (GDP)
4+ YOE4+ years cGMP experience, ability to interpret SOPs/regulations, strong written/verbal skills, data interpretation, experience with quality management systems and GxP electronic systems; Bachelor's in STEM preferred.
BMSDocs, CELabs, MES, SAP, ValG, DeltaV, Maximo, Infinity, Microsoft Power Automate, Smartsheet, Tableau, Microsoft Office
Dana-Farber Cancer Institute: Provides comprehensive cancer treatment and conducts oncological research.
Experience in cell processing quality systems, auditing, regulatory compliance (FACT, FDA, JCAHO, AABB, CLIA), proficiency with databases and spreadsheets, strong analytical and communication skills.
Bristol Myers SquibbNew York Stock Exchange: BMY: Develops and distributes innovative medicines for serious diseases.
4+ YOE4+ years cGMP experience (1+ year site manufacturing preferred). Bachelor's in STEM preferred (HS/Associates with experience considered). Proficiency with quality systems, data interpretation, MS Office and digital tools; strong communication and decision-making skills.
BMSDocs, CELabs, MES, SAP, ValG, DeltaV, Maximo, Infinity, Microsoft Power Automate, Smartsheet, Tableau, MS Office
ArdelyxNASDAQ: ARDX: Discovers and develops medicines for unmet medical needs.
8+ YOEBachelor's degree and 8+ years in pharmaceutical or biotechnology Quality, Quality Systems, training, or related work. Requires GxP, QMS, LMS, adult-learning, facilitation, compliance, and analytical skills.
Quality Management System (QMS), Learning Management System (LMS), GxP
PCI Pharma Services: Integrated pharmaceutical development, manufacturing, and global packaging services.
3+ YOEBachelor's degree in a relevant scientific field and 3+ years of relevant GMP industry experience, including 1+ year in Quality, or equivalent experience. Requires investigations, technical writing, and quality systems experience.
Commonwealth of Massachusetts: Providing public services and governance to the people of Massachusetts.
3+ YOEMinimum 3 years EDP experience including 1 year systems analysis; ability to collect user requirements, write specs and test plans; familiarity with SaaS, workforce development programs, federal/state reporting, and testing/documentation.
SaaS, CRM, analytics platforms, Microsoft Office, SharePoint, Teams