Quality Engineer

Our client is a biotechnology/medical device company looking to add a Quality Engineer to their team in Ventura County, CA.

Salary/Hourly Rate:

$95k – $100k

Position Overview:

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.

Responsibilities of the Quality Engineer:

• 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.

Required Experience/Skills for the Quality Engineer:

• 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.

Preferred Experience/Skills for the Quality Engineer:

• Six Sigma/Lean certification (Green Belt or equivalent).
• Proficiency in quality systems and Microsoft Office.
• Strong communication and leadership skills.

Education Requirements:

• Bachelor’s degree in Engineering, Business, or a related scientific discipline is required.

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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EOE/M/F/D/V/SO