99 product quality engineer jobs at 63 companies in Sharon, MA
1mo
Save
Mark Applied
Hide
1mo
Product Quality Assurance Engineer
Chelmsford, Massachusetts, United States
$82k-$90k/yrHybridFull Time
ZOLL Medical: Manufactures 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: 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.
Anduril Industries: Defense technology building autonomous military hardware and software.
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: Manufactures medical endoscopes and minimally invasive surgical tools.
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)
Johnson & JohnsonNYSE: JNJ: Develops and manufactures pharmaceutical drugs and medical devices.
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: Designs and manufactures semiconductors for power and IoT systems.
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.
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
Johnson & JohnsonNYSE: JNJ: Provides pharmaceutical products and medical technology healthcare solutions.
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
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
CSLASX: CSL: Develops and manufactures biopharmaceutical products and vaccines.
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.
VicorNASDAQ: VICR: Designs and manufactures high-performance modular power conversion systems.
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
CarrierNYSE: CARR: Provides HVAC, building automation, and refrigeration solutions globally.
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
CarrierNYSE: CARR: Manufactures HVAC, refrigeration, and fire safety systems.
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
RigakuTokyo Stock Exchange: 268A: Manufacturer of X-ray based analytical and industrial instrumentation.
5+ YOE5+ years in software quality engineering for regulated product development, BS in software-related field, experience with design control, risk management, verification/validation, and strong communication skills.