108 product quality engineer jobs at 67 companies in Concord, MA
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Product Quality Assurance Engineer
Chelmsford, Massachusetts, United States
$82k-$90k/yrHybridFull Time
ZOLL Medical: Global developer of medical devices and software for emergency care.
2+ YOEBachelor's in engineering or related,2+ years quality/product engineering experience in regulated industry,experience with complaint investigations,risk management,CAPA,and documentation;strong communication and data analysis skills.
Samsung HME America: U.S. medical imaging division providing ultrasound, digital radiography, and mobile CT systems to healthcare providers.
10+ YOEBS in engineering,10+ years manufacturing/service experience with electro-mechanical systems, expertise in root cause analysis, CAPA, risk management, and medical device quality systems.
Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Microsoft Outlook, Minitab
VulcanForms: Private U.S. metal additive manufacturing serving medical, defense, aerospace, and semiconductor customers with precision components.
4+ YOE4+ years in regulated quality engineering; engineering or materials science bachelor's preferred; expertise in FAIRs, capability studies, DFMEA/PFMEA, and AS9100 or ISO 13485 systems; metals experience required.
Anduril Industries: Defense technology developing AI-powered autonomous military systems.
5+ YOEBachelor's in engineering,5+ years in manufacturing/quality with OEM suppliers in regulated industries,knowledge of ISO9001/AS9100,QMS and SPC,FMEA,RCCA/8D,APQP/PPAP,GD&T,metrology tools,and eligibility for U.S. Secret clearance.
Lattice OS, AS9100, ISO 9001, FMEA, RCCA/8D, APQP, PPAP, GD&T
GVS North America Inc.Euronext Milan: GVS: Italian manufacturer of filtration solutions for healthcare, life sciences, energy, mobility, and workplace safety.
3+ YOEBachelor's in engineering, 3+ years quality engineering in manufacturing, knowledge of ISO/IATF standards, SPC/MSA/FMEA/APQP/PPAP/8D/CAPA, strong analytical and project skills.
SPC, MSA, FMEA, APQP, PPAP, 8D, CAPA, Microsoft Office, quality management systems
OlympusTokyo Stock Exchange: 7733: Precision technology for medical and scientific solutions.
2+ YOEBachelor’s degree in engineering and 2–4 years of quality engineering experience in FDA-regulated medical device manufacturing. Requires Six Sigma, statistics, risk management, regulatory, and Microsoft Office skills.
Six Sigma, Minitab, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Device Master Records (DMR), Device History Records (DHR), bills of materials (BOMs)
SMC Ltd.: Privately owned medical contract manufacturer serving medtech, diagnostics, and pharmaceutical companies with single-use devices and pharma services.
5+ YOEBS degree, 5+ years quality engineering in healthcare with new product development experience; knowledge of ISO 13485 and 21 CFR Part 820, SPC, ability to read 2D drawings, Word/Excel skills, and experience with PPAP, pFMEA, IQ/OQ/PQ, CAPA and audits.
DePuy Synthes: Johnson & Johnson’s private orthopaedic medical-technology business supplies surgeons and healthcare systems worldwide.
Provide quality leadership for medical device software projects, lead requirements and risk assessments, define test strategies, manage defects, support regulatory filings and audits.
SAP Product Lifecycle Management, Scripting Languages, Model-Based Systems Engineering (MBSE)
Infineon TechnologiesFrankfurt Stock Exchange: IFX: Global manufacturer of semiconductor and system solutions.
10+ YOEUniversity degree in engineering, physics, or materials science; 10+ years in quality management in semiconductor or technical environments; experience with power/PCB module manufacturing, qualification strategies, supplier evaluation, risk assessments, and strong customer communication skills.
SMC Ltd.: Privately owned medical contract manufacturer serving medtech, diagnostics, and pharmaceutical companies with single-use devices and pharma services.
5+ YOEB.S. degree and 5+ years quality engineering in healthcare with new product development; knowledge of ISO 13485 and 21 CFR Part 820; SPC and problem-solving skills; proficiency with Microsoft Word and Excel; ability to read 2D drawings and use inspection equipment.
DePuy Synthes: Johnson & Johnson’s private orthopaedic medical-technology business supplies surgeons and healthcare systems worldwide.
Provide software quality leadership for medical device products; lead risk assessments, define test strategies, manage verification and defects, support regulatory filings and audits, and mentor junior engineers.
SAP Product Lifecycle Management, Scripting Languages
WHOOP: Wearable technology developing health and fitness tracking devices.
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
SMC Ltd.: Privately owned medical contract manufacturer serving medtech, diagnostics, and pharmaceutical companies with single-use devices and pharma services.
5+ YOEB.S. degree and 5+ years quality engineering in healthcare with NPD experience; knowledge of ISO 13485, 21 CFR Part 820, SPC, 2D drawings; strong problem-solving, Word/Excel skills, and leadership ability.
Dynavac: Massachusetts manufacturer of high-vacuum space-simulation, thin-film deposition, and custom vacuum systems for aerospace, defense, and industrial customers.
5+ YOEEnsure manufactured products meet quality standards through hands-on inspection, measurement, documentation, corrective actions, and continuous improvement; BS in Industrial Engineering or Quality Management and 5+ years manufacturing experience preferred.
Profilometer, Laser Trackers, MRP, Epicor, Word, Excel
SymboticNASDAQ: SYM: AI-powered robotics and software for warehouse automation.
8+ YOEBachelor's degree in engineering and 8+ years in quality, electrical, reliability, or manufacturing engineering for complex manufactured products. Requires electrical systems expertise, quality methodologies, leadership, and advanced Excel.
APQP, DFMEA, PFMEA, Control Plans, PPAP, DOE, MSA, GR&R, SPC, 8D, Minitab, JMP, SAA, Microsoft Excel, PCBAs, ECUs
CSL Seqirus: Seqirus is a private global influenza-vaccine biotechnology developing, manufacturing, and distributing vaccines for public health.
5+ YOEBachelor’s degree in engineering or life sciences; 5+ years in quality, packaging, engineering, or manufacturing for medical devices or combination products; expertise in design controls, risk management, validation, and global regulations.
Vicor CorporationNASDAQ: VICR: Public U.S. electronics manufacturer making modular power components and power systems for OEMs and high-performance equipment.
5+ YOE5+ years product quality engineering in semiconductor/electronics manufacturing; strong knowledge of ISO 9001:2015 and IATF16949; Six Sigma Black Belt or CQE; statistics with JMP or Minitab; experience with PLM systems; BSEE or BSME required.
JMP, Minitab, Omnify, Agile, Matrix One, Microsoft Project, Visio
SensitechNYSE: CARR: Global leader in intelligent climate and energy solutions.
3+ YOE3+ years electronic product manufacturing quality experience, supplier quality management, ISO 9001 knowledge, SPC/FMEA, SAP experience, strong analytical and communication skills.
SAP, Statistical Process Control (SPC), FMEA, 5why’s
Sensitech: -owned supply-chain visibility providing real-time monitoring solutions for food, pharmaceutical, consumer-goods, and industrial customers.
3+ YOEHigh School/GED and 3+ years electronic product manufacturing quality experience with supplier quality management, ISO 9001, SPC, SAP, CAPA, FMEA; Six Sigma preferred; unrestricted US work authorization required.
CSL Behring: Global biotherapeutics leader driven by our promise to save lives.
3+ YOEBachelor’s degree in engineering, life sciences, or a relevant discipline; 3+ years in quality, engineering, manufacturing, or related technical work in regulated healthcare industries; knowledge of key FDA, ISO, and EU MDR requirements.
21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971, EU MDR