Job Title: Quality Engineer
Location: Petaluma, CA 94954
Job Type: On-site
Reports To: Quality Manager / Director of Quality

Job Summary:
We are seeking a highly motivated and detail-oriented Quality Engineer responsible for creating and executing process validations in support of a product line and quality testing equipment. This may include, but is not limited to bottling equipment, tanks, mixing equipment, water plant, environmental chambers, incubators, refrigerators and autoclaves. Experience in medical device or pharmaceutical manufacturing and a strong understanding of commissioning, qualification, and validation (CQV) processes are essential.

Key Responsibilities:

• Lead or support commissioning and validation activities (IQ/OQ/PQ) for new or modified manufacturing equipment and production lines.
  

• Assist with test method validations and establishing statistical process control indexes.
  

• Assist with closing out CAPA and remediation of a design history file.
  

• Collaborate cross-functionally with Engineering, Validation, Manufacturing, and Quality Assurance teams to ensure smooth project execution.
  

• Review and approve commissioning protocols, validation plans, and engineering documents to ensure compliance with FDA, ISO 13485, and cGMP standards.
  

• Participate in FAT (Factory Acceptance Testing) and SAT (Site Acceptance Testing) for equipment installation.
  

• Investigate and resolve deviations, non-conformances, and quality issues identified during commissioning and routine manufacturing.
  

• Support regulatory inspections and audits by preparing documentation and serving as a subject matter expert (SME) in relevant areas.

Qualifications:
Required:

• Bachelor’s degree in Engineering, Life Sciences, or related technical discipline.
  

• Minimum 3–5 years of quality engineering experience in the medical device or pharmaceutical industry.
  

• Hands-on experience with commissioning, qualification, and validation (IQ/OQ/PQ) of production equipment or lines.
  

• Strong knowledge of FDA regulations, ISO 13485, and cGMP.
  

• Excellent problem-solving skills and attention to detail.
  

• Proficiency in technical writing and documentation.

Preferred:

• Certification such as CQE (Certified Quality Engineer) or Six Sigma Green/Black Belt.
  

• Experience with cleanroom environments and aseptic processing.
  

• Familiarity with electronic quality management systems (eQMS) and validation software

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