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Service & Delivery Quality Process Engineer
Ra'anana or Cambridge
OnsiteFull Time
5+ YOE5+ years in quality & regulatory roles in the medical device industry, experience with software as a medical device, familiarity with ISO13485/MDSAP/EU-MDR/CFR, strong communication, problem solving, Excel/PowerPoint/Word skills; Bachelors preferred; PMP and data analysis preferred.
Microsoft Excel, Microsoft PowerPoint, Microsoft Word
4d
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Engineer, Process Engineering
Danvers, Massachusetts, United States
$65k-$105k/yr OnsiteFull Time
1+ YOETechnical degree or equivalent experience,1–5 years in manufacturing/engineering/quality,knowledge of NC/CAPA and quality processes,ability to manage documentation,testing,logistics,and continuous improvement.
ETQ, SAP, eMP, Lynx
1w
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Associate Staff - Fabrication & Process Quality Engineer (Fabrication Engineering Group)
Lexington, Massachusetts, United States
$116k-$182k/yr OnsiteFull Time
5+ YOEMaster's degree in engineering or Bachelor's +5 years, leadership in quality management, SPC and root-cause analysis experience, corrective action and supplier quality expertise, ability to obtain Secret clearance.
2mo
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Principal Analyst, Quality Business Process
Arden Hills or Valencia or Spencer or Marlborough or Quincy or Maple Grove or Coventry
$102k-$194k/yr HybridFull Time
7+ YOEBachelor's in engineering/science, 7+ years in quality/engineering/operations/QA, 3+ years in medical device or regulated industry, business process design and quality systems knowledge; SAP S/4HANA experience preferred.
SAP S/4HANA
1mo
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Senior Quality Engineer, Quality Operations
Marlborough, Massachusetts, United States
$90k-$110k/yr OnsiteFull Time
5+ YOE5+ years quality engineering experience in regulated medical device/IVD manufacturing; strong knowledge of FDA QMSR, ISO 13485/14971, GMPs, process validation, change control, CAPA, supplier quality, eQMS; Bachelors required.
eQMS, quality analytics tools, electronic quality systems
1mo
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Senior Quality Engineer
North Reading, Massachusetts, United States
$137k-$186k/yr OnsiteFull Time
7+ YOEBachelor's in engineering or STEM, 7+ years quality engineering experience in electromechanical/precision hardware, experience with APQP/PPAP, DFMEA/PFMEA, metrology (CMM), MRB, SPC/MSA, and supplier quality processes; Six Sigma/CQE preferred.
CMM, Minitab, JMP, APQP, PPAP, DFMEA, PFMEA, SPC, MSA, Gage R&R, 8D, 5-Why, Fishbone, GD&T, ISO 9001, IATF 16949, AS9100, MRB
1mo
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Senior Process Engineer
Hopkinton, Massachusetts, United States
$80k-$110k/yr OnsiteFull Time
5+ YOEBachelor's in engineering, 5+ years cell and gene therapy process/analytical experience, hands-on aseptic manufacturing and cell culture experience, quality systems (deviations, CAPA, change control), experimental design, data analysis, and technical writing; Excel proficiency.
Microsoft Excel
4d
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Engineer, Process Engineering
Danvers, Massachusetts, United States
$65k-$105k/yr OnsiteFull Time
1+ YOETechnical degree or equivalent experience,1+ years in manufacturing/engineering/quality,knowledge of quality systems (NC,CAPA),strong organization,communication,and problem-solving skills.
ETQ, SAP, eMP, Lynx
1mo
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Quality Engineer
Burlington, Massachusetts, United States
$76k-$114k/yr OnsiteFull Time
2+ YOE2+ years manufacturing quality experience; ability with part prints, inspection tools (micrometers, calipers, CMM, vision), create inspection plans, root cause analysis, ISO 9001 processes; comfortable with spreadsheets and Word; BS in technical field preferred.
micrometer, caliper, CMM, vision systems, Microsoft Excel, Microsoft Word
4d
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Engineer, Process Engineering
Danvers, Massachusetts, United States
$65k-$105k/yr OnsiteFull Time
1+ YOETechnical degree or equivalent experience, 1+ years in manufacturing/engineering/quality, familiarity with NC/CAPA and quality systems, strong documentation, coordination, and continuous improvement skills; medical device experience preferred.
ETQ, SAP, eMP, Lynx
1d
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Manufacturing Process Engineer
Westford, Massachusetts, United States
$80k-$115k/yr OnsiteFull Time
3+ YOEBSc in engineering required, 3+ years manufacturing engineering experience, PCBA/SMT/wave soldering knowledge, PFMEA/PCA/DFM experience, lean and TQM experience, ISO quality systems, strong communication and problem-solving skills.
PCBA, SMT, wave soldering, Lean, PFMEA, 5 why, 8D, ISO
1w
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Development Quality Engineer
Westford, Massachusetts, United States
$61k-$123k/yr OnsiteFull Time
2+ YOEProvide process/quality engineering support for manufacturing and product development; perform root cause analysis, implement corrective/preventive actions, develop quality plans and FMEAs.
1w
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Development Quality Engineer
Westford, Massachusetts, United States
$61k-$123k/yr OnsiteFull Time
2+ YOEBachelor's in engineering (electrical preferred) plus 2+ years experience or Master's with 0+ years; knowledge of process and quality engineering, FMEA, data analysis, and medical device manufacturing.
2mo
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Quality Engineer
Ashaway, Rhode Island, United States
$90k-$110k/yr HybridFull Time
1+ YOEStrong ISO 13485:2016 knowledge, CFR parts 820 experience; statistical methods; process validation; ERP; 1-3 years in medical device manufacturing; MS Office; CAPA experience.
Minitab, ERP, MS Office
1mo
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Quality Engineer II - Design & Reliability Assurance
Princeton or Plainsboro or Braintree or Chicago or Columbia
$71k-$98k/yr OnsiteFull Time
4+ YOEBachelors in science/engineering, 4+ years quality/process/R&D engineering for medical devices, risk management and design control expertise, statistical sampling/analysis experience, MS Office and statistical software proficiency.
Microsoft Office Suite, Minitab, TrackWise, Agile
1w
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Design and Sustaining Quality Engineer
Clinton, Massachusetts, United States
$110k-$198k/yr OnsiteFull Time
8+ YOEBachelor's in engineering or equivalent,8+ years quality/new product/process or manufacturing engineering in medical device industry,ISO 13485 and CAPA experience,validation and audit experience,Excel power-user and BI basics.
Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Excel/Sheets, Power BI, Tableau, Looker
1mo
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Senior Manufacturing Quality Engineer
Cambridge, Massachusetts, United States
$110k-$140k/yr OnsiteFull Time
5+ YOEBachelor's in engineering or equivalent; 5+ years manufacturing quality experience in medical device industry; experience with Class II/III devices, FDA/ISO 13485 QMS, process validation, IQ/OQ/PQ, SPC, DOE, and root-cause analysis.
1mo
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Senior Supplier Quality Engineer
Westborough or Worcester or Center Valley or United States
$98k-$135k/yr HybridFull Time
5+ YOEBA/BS in life science, engineering, or physical science; 5+ years supplier quality engineering; experience with APQP/FAI/SCAR/SCN, ISO 9001/13485 and FDA processes; fiber-optic laser system or medical device experience preferred; ~20% travel.
1mo
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Principal Operations Quality Engineer
Andover, Massachusetts, United States
$108k-$205k/yr OnsiteFull Time
8+ YOEBachelor's in STEM + 8 years related experience, U.S. citizenship with ability to obtain/maintain DoD Secret clearance (active required day 1), experience with root cause analysis, quality metrics, manufacturing processes, and interpreting drawings.
Advanced Product Quality Planning (APQP), PFMEA, SPC, pareto analysis, cause/effect diagrams, process mapping, J-STD-001, ISO 9001, AS9100
2w
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Senior Engineer/Manager, Process Validation
Bedford, Massachusetts, United States
$140k-$161k/yr HybridFull Time
8+ YOEBachelor's (8+ yrs) or Master's (6+ yrs) in engineering/life sciences, 6–8+ years pharma/biotech process validation experience, CMO collaboration, cGMP/ICH knowledge, DOE/SPC statistical methods.
JMP