31 principal quality engineer jobs at 13 companies in Holden, MA
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Principal Operations Quality Engineer
Andover, Massachusetts, United States
$108k-$205k/yrOnsiteFull Time
RTXNYSE: RTX: Aerospace and defense providing advanced technology solutions.
8+ YOEBachelor's in STEM and minimum 8 years' related experience; experience with root cause analysis, quality metrics, manufacturing processes, and APQP/PFMEA; eligibility for U.S. security clearance required.
OlympusTokyo Stock Exchange: 7733: Precision technology for medical and scientific solutions.
10+ YOEBachelor's in engineering, 10+ years product quality experience in medical devices or regulated environment, CAPA and complaint investigation expertise, knowledge of 21 CFR Part 820, ISO 13485, ISO 14971, strong analytical and leadership skills, available for regional/international travel.
PFMEAs, 8D, DMAIC, 21 CFR Part 820, ISO 13485, ISO 14971
Draper: Independent research and development organization focused on national challenges.
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.
Fresenius Medical CareFrankfurt Stock Exchange, NYSE: FME, FMS: Global provider of dialysis products and renal healthcare services.
5+ YOEBachelor's degree and 5–8 years of related experience, or master's degree and 3 years. Requires analytical, engineering mathematics, technical writing, quality, risk management, and design control expertise.
Microsoft Office, Experimental Design (DOE), Risk Management, Hazard Analysis and Critical Control Point (HACCP), Failure Modes and Effects Analysis (FMEA), Gage Reproducibility and Repeatability (R&R), ISO 14971-2019, CAPA, SCARs, NCMRs, dFMEAs, pFMEAs
HiscoxLondon Stock Exchange: HSX: Public Bermuda-headquartered specialist insurance group serving businesses, professionals, homeowners, and global reinsurance clients.
10+ YOE10+ years in test automation/software engineering with 5+ years in principal/lead roles; hands-on TypeScript, Playwright, Cucumber, CI/CD, cloud-native testing, performance and API testing, and strong communication and leadership skills.
BAE SystemsLSE: BA.: Global defense, aerospace, and security technology.
4+ YOEBachelor's degree with 4+ years (or 8+ years without) engineering/technical experience; active Secret clearance; ability to obtain SAP/SAR access; strong communication, leadership, and quality engineering skills.
Principal Design Quality Assurance Engineer - Endoscopy
Marlborough, Massachusetts, United States
$107k-$203k/yrHybridFull Time
Boston ScientificNYSE: BSX: Global medical technology leader providing innovative solutions for patients.
8+ YOEBachelors in engineering,8+ years medical device engineering experience,deep knowledge of 21 CFR 820,EU MDR,ISO 13485/14971,experience leading quality deliverables and risk management,10-20% travel.
Principal Design Quality Assurance Engineer - Endoscopy
Marlborough, Massachusetts, United States
$107k-$203k/yrHybridFull Time
Boston ScientificNYSE: BSX: Global medical technology leader providing innovative solutions for patients.
8+ YOEBSc in engineering,8+ years medical device engineering experience,deep knowledge of 21 CFR 820,MDD/EU MDR,ISO 13485 and ISO 14971,ability to lead quality deliverables and audits,travel ~10-20%.
BAE SystemsLSE: BA.: Global defense, aerospace, and security technology.
4+ YOEBachelor's in a technical field or equivalent experience,4+ years engineering experience,active Secret clearance and ability to obtain Top Secret/SCI with polygraph,knowledge of industry standards and software QA tools,Agile/Scrum experience.
Principal Design Quality Assurance Engineer - Endoscopy
Marlborough, Massachusetts, United States
$107k-$203k/yrHybridFull Time
Boston ScientificNYSE: BSX: Global medical technology leader providing innovative solutions for patients.
8+ YOEBachelor's in engineering,8+ years medical device engineering,deep knowledge of US/International device regulations,experience with risk management and design controls,10-20% travel.
Nova Biomedical: A private US manufacturer of analytical instruments and consumables serving biopharmaceutical, clinical, veterinary, and food-and-beverage customers.
3+ YOEBS in Engineering or Life Sciences, 3+ years medical device/IVD design control experience; knowledge of 21 CFR 820, ISO 13485, ISO 14971, IVDR; risk management, V&V, and statistical methods.
MilliporeSigma: Merck KGaA's U.S./Canada life science business supplies research tools, bioprocessing products, and services to scientists and drugmakers.
8+ YOEBachelor's or master's in process engineering, 8 years in medical, biotechnology, or biopharmaceutical manufacturing preferred, project management, GMP, quality regulations, and English fluency.
MilliporeSigma: Merck KGaA's U.S./Canada life science business supplies research tools, bioprocessing products, and services to scientists and drugmakers.
8+ YOERequires a BS or MS in Process Engineering, 8 years of relevant manufacturing experience preferred, project management expertise, GMP and quality regulation knowledge, strong communication, analytical, and documentation skills.
GetingeNasdaq Stockholm: GETI B: Providing medical solutions to improve clinical outcomes and workflows.
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
Principal Process Engineer, Manufacturing Process Development
Woburn or Allston
$140k-$170k/yrOnsiteFull Time
Terrestrial Bio: Private U.S. biotechnology developing needle-free microarray patches for delivering GLP-1 medicines, vaccines, and other therapies.
8+ YOEBachelor's degree or higher in engineering, 8+ years of process engineering experience, quality-by-design and DoE expertise, quantitative modeling, data analysis, biopharmaceutical or medical-device process development, and people management experience.
Integra LifeSciencesNasdaq: IART: Global leader in regenerative technologies and neurosurgical solutions.
10+ YOERequires a technical engineering degree and 10+ years of medical device development experience, including FDA and ISO quality systems, Python, embedded systems, data acquisition, polymer design, 3D CAD, and bio-fluid mechanics.
Python, Electronic Medical Records (EMR), SolidWorks, Computational Fluid Dynamics (CFD), Finite Element Analysis (FEA), Design of Experiments (DOE), Six Sigma, CNC, RS-485, CAN-Bus, Bluetooth, MEMS
Senior Principal Program Quality NRE Lead – EPAWSS V2/TACAIR
Nashua, New Hampshire, United States
$150k-$254k/yrHybridFull Time
BAE SystemsLSE: BA.: Global defense, aerospace, and security technology.
8+ YOEBachelor's degree and 8+ years technical experience; knowledge of APQP/PPAP, 8D, SPC, AS9100 family, FAI/PPV; ability to read drawings, lead teams, and obtain Secret clearance.
DOORs, Jira, Bit Bucket, Microsoft Word, Microsoft Excel, Microsoft PowerPoint
Infineon TechnologiesFrankfurt Stock Exchange: IFX: Global manufacturer of semiconductor and system solutions.
8+ YOE8+ years in failure analysis (5+ focused on power semiconductors), expertise in destructive/non-destructive analysis, degree in engineering/materials or HS+10yrs, FA certifications preferred, proficiency with FA tools and data analysis.
curve tracers, dual-pulse testers, Lock-in Thermography (LIT), Dynamic IR Thermography, Focused Ion Beam, FIB-SEM, TEM, SEM, AMETEK Dage, Quorum Technologies, Oxford Instruments, JMP, Python