8 quality systems engineer jobs at 5 companies in Westbrook, ME
2w
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Senior Supplier Quality Engineer
Portsmouth, New Hampshire, United States
OnsiteFull Time
8+ YOEBachelor's in engineering or related field,8+ years QA experience,expertise with ISO 13485 and 21CFR quality systems,auditing and statistical methods,leadership and decision-making skills.
1w
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Quality Assurance (QA) Roles (Entry to Mid-Level) (Night-Shift)
Portsmouth, New Hampshire, United States
OnsiteFull Time
0+ YOEBachelor’s degree or equivalent experience in life sciences/engineering preferred; knowledge of GMP, deviations, CAPA, investigations, batch record review, and quality systems; 3–7+ years QA experience preferred for mid-level roles.
TrackWise, Veeva, LIMS
3mo
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Process Engineer
Sanford, Maine, United States
OnsiteFull Time
0+ YOEB.S. in Engineering (Chemical, Mechanical, or Electrical); 0-5 years manufacturing/engineering; knowledge of Quality Systems; SAP, Excel, Word, Outlook; good communications; team oriented.
SAP, Excel, Word, Outlook
3w
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Electrical Test Engineer
Portsmouth, New Hampshire, United States
OnsiteFull Time
2+ YOEBachelor's in electrical engineering or related field, 2+ years test or manufacturing engineering experience, strong electrical troubleshooting and test procedure development, familiarity with insulation testing and quality systems.
multimeters, oscilloscopes, power supplies, insulation testers, data acquisition systems, LabVIEW, Python, SolidWorks
6d
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Manufacturing Process Engineer I
Scarborough, Maine, United States
$51k-$101k/yr OnsiteFull Time
Bachelor's degree in mechanical engineering or equivalent education and experience; engineering knowledge, data analysis, and familiarity with cGMP, ISO 13485, FDA, and quality systems required.
Microsoft Excel, Microsoft PowerPoint, Microsoft Power BI, Minitab, JMP, Design of Experiments (DOE), CAPA, SOPs, ANSI/AQL, ISO 13485, cGMP, FDA
6d
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Manufacturing Process Engineer I
Scarborough, Maine, United States
$51k-$101k/yr OnsiteFull Time
Bachelor's degree in mechanical engineering or equivalent experience; knowledge of engineering principles, data analysis, quality systems, cGMP, and ISO 13485. Experience with regulated manufacturing preferred.
Microsoft Excel, Microsoft PowerPoint, Microsoft Power BI, Minitab, JMP, Design of Experiments (DOE)
2mo
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Computer Systems Validation Specialist III
Portsmouth, New Hampshire, United States
OnsiteFull Time
3+ YOEBachelor's in computer science or engineering; 3+ years CSV experience; 3+ years in a cGMP facility; experience with 21 CFR Part 11 and ISPE GAMP; background in biotech/pharma/medical devices; ability to work on-site in Portsmouth, NH.
QMS software, Documentation tools
1mo
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Regulatory Affairs Specialist I
Minnetonka or Portsmouth
HybridFull Time
1+ YOEBachelor's degree in science/engineering,1-3 years regulatory affairs experience in medical device industry,experience with international registrations and quality system regulations,strong communication and organization skills.