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Manufacturing Engineer
Camarillo, California, United States
$100k-$110k/yr OnsiteFull Time
5+ YOEBachelor's in engineering, 5+ years manufacturing engineering in regulated (medical device/pharma) environments; Lean Six Sigma, process validation (IQ/OQ/PQ), pFMEA, SPC/Cpk, CAPA/NCR, DOE, CAD proficiency; ability to travel up to 10%.
Lean Six Sigma, SPC, Cpk, Gage R&R, IQ/OQ/PQ, pFMEA, CAPA, NCR, CAD, Design of Experiments (DOE)
1mo
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Quality Engineer - Complaints
Camarillo, California, United States
$95k-$105k/yr OnsiteFull Time
5+ YOEBachelor's in engineering/biological/related field, 5+ years quality experience in biotech/pharma/medical device, GMP/cleanroom experience, CAPA/change control/document control/validation knowledge, Six Sigma/Lean/SPC experience, strong writing and problem-solving skills.
CAPA, Change Control, Statistical Process Control (SPC), Six Sigma, Lean Manufacturing, 5S, Value Stream Mapping, Control Plans, PFMEA, Process Mapping, Good Documentation Practices (GDP), ISO 9001, ISO 13485, 21 CFR Part 210, 21 CFR Part 211, 21 CFR Part 820, Microsoft Office
2w
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Application Engineer - Single Use Bag Solutions
Camarillo, California, United States
$120k-$150k/yr OnsiteFull Time
7+ YOEBachelor's in engineering required (master's preferred),7+ years engineering experience in biotech/pharma/medical device, single-use bag expertise, CAD proficiency, supplier qualification and RCA/CAPA experience.
CAD, Microsoft Office
1w
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Manager, Quality & Regulatory Compliance
Goleta, California, United States
$140k-$150k/yr OnsiteFull Time
7+ YOEBachelor's degree in engineering, quality, regulatory affairs or life sciences; 7+ years in medical device or regulated industry; ISO 13485, CAPA, audits, supplier quality, risk management, and design control experience.
1mo
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Director, Quality Management Systems (Athlone, L, IE)
Athlone or Morrisville or Pleasanton or Santa Barbara
OnsiteFull Time
Lead and maintain global QMS (ISO 13485, EU-MDR, MDSAP), manage eQMS integrations, support regulatory audits/inspections, lead CAPA and quality projects, manage teams, budgets and cross-functional stakeholders.
Veeva, PLM, ERP, eQMS
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Supplier Quality Engineer
Camarillo, California, United States
$95k-$105k/yr OnsiteFull Time
5+ YOEBachelor's in biological sciences/engineering, minimum 5 years quality experience in a regulated industry, supplier auditing experience, knowledge of FDA 21 CFR Part 820 and ISO 13485, CAPA and risk management, SCAR management.
2w
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Application Engineer - Needle Fill-Finish Manufacturing
Camarillo, California, United States
$120k-$150k/yr OnsiteFull Time
7+ YOEBachelor's in engineering required (Master's preferred),7+ years biotech/pharma/device engineering experience, CAD proficiency, GMP and final-fill knowledge, strong customer-facing and RCA/CAPA experience, ability to travel up to 20%.
CAD, Microsoft Office
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QC Analyst, Quality Control Laboratory
Camarillo, California, United States
$90k-$110k/yr OnsiteFull Time
3+ YOE3+ years QC experience in a GMP biologics laboratory; BSc/MS in biology/chemistry/biochemistry; technical proficiency with HPLC/UPLC, ELISA, capillary electrophoresis; experience with method validation, OOS/OOT investigations, CAPA and regulatory expectations.
HPLC, UPLC, ELISA, cIEF, CE-SDS, LIMS, Chromeleon
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Director, Quality Assurance, Manufacturing
Lompoc, California, United States
$144k-$198k/yr OnsiteFull Time
12+ YOE5+ MgmtLead QMS and regulatory compliance (ISO 9001, ISO 13485, MDSAP, FDA); direct quality assurance audits, supplier oversight, CAPA follow-up, PRRC/FDA correspondent duties; typically 12+ years experience with 5+ years management.
3w
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Senior QSAT Engineer
Carpinteria, California, United States
$125k-$195k/yr HybridFull Time
8+ YOEBachelor's in engineering, 8+ years quality engineering in regulated industry, CAPA/NCR ownership, strong root-cause analysis (Six Sigma/Lean), knowledge of ISO 13485, FDA 21 CFR Part 820, ISO 14971, FMEA interpretation, and business-level English.
Six Sigma, Lean, 5 Whys, Fishbone