286 quality lead jobs at 179 companies in Boston, MA
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Quality Manufacturing Lead
Haverhill, Massachusetts, United States
$90k/yrOnsiteFull Time
SOFIE: Produces radiopharmaceuticals and imaging systems for molecular diagnostics.
Provide real-time quality oversight on the manufacturing floor, review and release batch records, lead investigations, maintain GMP records, and ensure compliance with 21 CFR and SOPs.
RTXNYSE: RTX: RTX provides advanced aerospace and defense systems and services.
10+ YOEU.S. citizen with active transferable Secret clearance, Bachelor’s degree, ~10 years quality/engineering/manufacturing/operations experience, AS9100 experience, program quality leadership and cross-discipline quality expertise.
AlkermesNASDAQ: ALKS: Develops medicines for psychiatric and neurological disorders.
10+ YOEBSc in a scientific discipline, 10+ years pharmaceutical experience (preferably oral solid dose) with strong analytical, cleaning validation, manufacturing QA, cGMP and data integrity expertise; up to 15% travel.
Waltham or United States or Puerto Rico or North America
$78k-$113k/yrHybridFull Time
SanofiEuronext Paris: SAN: Researches, develops, and manufactures medicines and vaccines globally.
5+ YOEBachelor's degree or equivalent; minimum 5 years experience in training, learning management, quality, compliance, documentation, or QA; LMS and iLearn experience preferred; familiarity with GxP training requirements.
HenkelXETRA: HEN3: Manufactures laundry, beauty, and adhesive products globally.
6+ YOEBachelor's in Chemical Engineering/Chemistry or related, 6+ years in chemical manufacturing or quality, knowledge of ISO/QS, Six Sigma/8D/A3, SAP/LIMS/SmartFactory experience, cGMP preferred, occasional travel.
Associate Director, Clinical Study Quality Lead (Hybrid)
Boston, Massachusetts, United States
$161k-$241k/yrHybridFull Time
Vertex PharmaceuticalsNASDAQ: VRTX: Develops and sells prescription drugs for serious genetic diseases.
8+ YOEBachelor's degree in a scientific or allied health field and 8+ years of relevant experience; expertise in ICH-GCP, global regulations, clinical trials, quality risk management, CAPA, metrics, and Microsoft Office.
Microsoft Office, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Smartsheet, Visio, CAPA, ICH-GCP, FDA, EMA, MHRA
QuanterixNASDAQ: QTRX: Developing digital immunoassay technology for ultra-sensitive protein detection.
5+ YOE5+ years quality experience in medical device/biotech; Bachelor’s in engineering or related field required; IVD/instrumentation and reagents experience; knowledge of design control, risk management, and eQMS tools.
Tango TherapeuticsNasdaq Capital Market: TNGX: Develops precision cancer medicines using synthetic lethality principles.
8+ YOEManage and continuously improve QMS for GxP compliance, document control, training, records, CAPA, metrics, and audit readiness; 8+ years QA/Compliance and bachelor\u0002s in life sciences/quality required.
GetingeNasdaq Stockholm: GETI B: Manufactures medical equipment for acute care and life sciences.
7+ YOEBachelor in engineering/science, 7+ years in medical device/pharmaceutical/regulated industry, strong QMS knowledge (CAPA, audits), FDA/ISO13485 familiarity, ERP and Microsoft Office proficiency.
Microsoft Word, Microsoft PowerPoint, Microsoft Excel, SAP
Lead Quality Engineer - Aerospace & Defense Industry!
Exeter, New Hampshire, United States
OnsiteFull Time
C/A Design: Engineered cooling solutions and brazing for aerospace and defense.
5+ YOEBachelor's in engineering or equivalent, 5+ years quality engineering in aerospace, AS9100 experience, NADCAP familiarity preferred, GD&T and inspection methods knowledge, strong analytical and communication skills.
VulcanForms: Provides industrial-scale metal additive manufacturing and precision machining services.
8+ YOE8+ years in quality engineering in regulated advanced manufacturing; engineering or materials science bachelor's preferred; expertise in FAIRs, process capability, DFMEA/PFMEA, AS9100 or ISO 13485, and metal manufacturing.
American Flowform & Machining: Precision metal forming and machining for demanding industrial applications.
3+ YOE3+ years manufacturing/aerospace quality experience preferred; support AS9100D QMS, lead root cause/CAPA, interpret drawings/GD&T, perform FAIRs, and use Microsoft Office and ERP/QMS systems. U.S. citizenship required.
AS9100D, GD&T, CMM, 5-Why, Fishbone, Process Mapping, Microsoft Outlook, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Visio, Microsoft Project
4+ YOEBachelor's degree with 4-6+ years (or 10-12+ years experience in lieu); experience with supplier quality, APQP/PPAP, 8D/RCCA, AS9145/AS9100; strong data analysis, communication, and MS Office skills; ability to obtain Secret clearance and U.S. person required.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint
Remix Therapeutics: Develops small molecule therapies to reprogram RNA processing.
15+ YOE10+ MgmtLead and build a global quality function; ensure GxP compliance; lead inspections and regulatory interactions; scale QMS for clinical to commercial.
HoneywellNASDAQ: HON: Manufactures aerospace products, building technologies, and industrial control systems.
6+ YOEBachelor in a technical discipline,6+ years manufacturing quality experience,proficiency in quality management systems,audit and corrective action experience,statistical analysis knowledge,and ability to lead continuous improvement. U.S. person required.
TTM TechnologiesNASDAQ: TTMI: Manufactures printed circuit boards and radio frequency technology solutions.
8+ YOEMaintain and improve QMS, lead internal/external audits, assess risks, drive corrective actions; Bachelor's degree in engineering/quality/manufacturing or related; 8+ years experience (6+ with Master's); proficiency with Microsoft Office and quality software.
SHINE Technologies: Developer of medical isotopes and nuclear fusion technology.
15+ YOE10+ MgmtBachelor's degree and 15+ years of progressive quality or regulated manufacturing experience, including 10+ years leading managers and multidisciplinary teams across multiple sites.
Quality Management System (QMS), SPECT, Ilumira Therapeutics, GxP, API, CAPA, FDA, Health Canada, ICH, USP, GMP
WHOOP: Wearable technology for personalized health and performance tracking.
15+ YOEBachelor's degree in a technical engineering discipline and 15+ years leading product, manufacturing, or NPI quality organizations in high-volume consumer electronics or complex hardware, with significant people leadership.
DFMEA, PFMEA, CTQ, SPC, MSA, DOE, CAPA/8D, Design for Manufacturability, AI
Draper: Designs and develops advanced guidance and navigation technologies.
7+ YOEBachelor of Science in engineering required, with 7–10 years of quality or engineering experience. Requires Lean Six Sigma, ISO 9001:2015 and AS9100 knowledge, analytical skills, and ability to lead quality teams.