13 quality systems specialist jobs at 7 companies in Dover, NH
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Quality Systems Specialist - CAPA
Manchester, New Hampshire, United States
OnsiteFull Time
Merrimack Manufacturing: Private U.S. medical-device contract manufacturer producing lifesaving devices for designers and their patients.
2+ YOEAssociate or bachelor's degree preferred; 2–5 years in quality systems, quality assurance, or a regulated industry. Requires CAPA experience, ISO 13485 and FDA QSR knowledge, root cause analysis, and Microsoft Office proficiency.
Microsoft Office, electronic QMS systems, 5-Why, Fishbone, fault tree analysis
Fresenius Medical Care North America: Private U.S. renal healthcare providing dialysis, kidney care, vascular services, pharmaceuticals, and dialysis equipment.
6+ YOEBachelor's degree, 6+ years related experience, deep knowledge of quality systems, recalls/corrections & removals, regulatory requirements (US, Health Canada, Mexico), Microsoft Access/Outlook/ERP skills, audit and training experience.
Microsoft Access, Microsoft Outlook, ERP software, Microsoft Office
HexcelNYSE: HXL: Global leader in advanced lightweight composite technology.
HS/GED required; proficiency with Microsoft Office; experience supporting CMMS, LMS, DMS, NCM/CAPA and calibration databases; records management, report generation, strong written and verbal communication; U.S. citizenship required.
CMMS, LMS, DMS, NCM, CAPA, Microsoft Word, Microsoft Outlook, Microsoft Excel, Microsoft PowerPoint
LonzaSIX Swiss Exchange: LONN: A global partner to the pharmaceutical and biotech industries.
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.
PCI Pharma Services: Global contract development and manufacturing organization for biopharma.
3+ YOEBachelor's degree in a relevant scientific field and 3+ years of relevant GMP industry experience, including 1+ year in Quality, or equivalent experience. Requires investigations, technical writing, and quality systems experience.
LonzaSIX Swiss Exchange: LONN: A global partner to the pharmaceutical and biotech industries.
3+ YOERequires 3+ years in quality assurance, compliance, or quality systems in a GMP-regulated life sciences environment, with cGMP, FDA, ICH, quality events, audits, and eQMS experience.
PCI Pharma Services: Global contract development and manufacturing organization for biopharma.
2+ YOERequires 2+ years in GMP, ISO, or FDA-regulated environments, quality-system technical writing, cGMP investigations, root-cause and risk analysis; science or engineering bachelor's preferred.
LonzaSIX Swiss Exchange: LONN: A global partner to the pharmaceutical and biotech industries.
Experience with cGMP, good documentation practices, familiarity with manufacturing and quality systems, ability to identify compliance issues and support inspection readiness.
LonzaSIX Swiss Exchange: LONN: A global partner to the pharmaceutical and biotech industries.
5+ YOEMinimum 5+ years in Quality Assurance/Quality Systems in GMP-regulated pharma/biotech; strong knowledge of cGMP; experience with deviations, CAPAs, change controls, and audits; excellent communication and cross-functional collaboration; experience with eQMS (TrackWise, Veeva, MasterControl) preferred.
TrackWise, Veeva, MasterControl, Quality Management System
Sun Pharmaceutical IndustriesNSE: SUNPHARMA: Global specialty generic pharmaceutical headquartered in India.
5+ YOERequires a high school diploma, 5+ years supporting manufacturing or quality departments, and knowledge of GMP, quality systems, CAPAs, change controls, deviations, documentation, and compliance reporting.
LonzaSIX Swiss Exchange: LONN: A global partner to the pharmaceutical and biotech industries.
8+ YOEBachelor's in life sciences,8+ years QA in GMP-regulated environment,strong GMP (FDA/EMA/ICH) knowledge,audit and inspection leadership,CAPA and quality systems experience,TrackWise familiarity,data integrity understanding;CQA preferred.
Laborie Medical Technologies: Privately owned medical-device manufacturer serving clinicians and hospitals with diagnostic/therapeutic products in urology, gastroenterology, and obstetrics.
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.