Quality Engineer
Atrium Staffing•Ventura County, CA
25d•$95,000 - $100,000
About The Position
The Quality Engineer will lead quality investigations, drive process improvements, and ensure compliance with international standards. This Quality Engineer will collaborate across Operations, Manufacturing, R&D, and Quality teams to maintain product integrity and regulatory compliance.
Requirements
- 5+ years in quality operations within biotech or pharma manufacturing.
- Strong knowledge of ISO 9001/13485 and FDA regulations.
- Experience with technical documentation and continuous improvement tools.
Nice To Haves
- Six Sigma/Lean certification (Green Belt or equivalent).
- Proficiency in quality systems and Microsoft Office.
- Strong communication and leadership skills.
Responsibilities
- Investigate product defects and implement CAPA.
- Collaborate with cross-functional teams on quality initiatives.
- Drive process improvements using Six Sigma and SPC.
- Maintain compliance with ISO 9001/13485 and GDP standards.
- Support documentation, audits, and training programs.
Benefits
- Medical, dental, and vision plans.
- Flexible Spending Accounts (FSA).
- Life and AD&D insurance.
- Disability coverage.
- Employee Assistance Program (EAP).
- 401(K) retirement plan.
- Additional wellness and referral programs.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Administrative and Support Services
Number of Employees
101-250 employees
