Quality Engineer

Responsibilities

• Lead quality investigations related to in‑the‑market defects to identify root cause and implement corrective actions and preventative actions.
• Collaborate with cross‑functional teams to investigate failure modes and execute impact assessments to ensure appropriate countermeasures are developed and launched.
• Interface with customers and suppliers to address non‑conformances identified during manufacturing.
• Lead process improvement initiatives utilizing Statistical Process Control (SPC) and Six Sigma methodology such as 5S, Value Stream Mapping, Control Plans, PFEMA, and Process Mapping.
• Lead Manufacturing Quality Assurance aspects of process control, initiating projects to ensure that targeted process flows are effective and achieve operational requirements, and provide guidance to SME’s on root cause and corrective action (RCCA) activities.
• Recommend process improvements to management and execute to ensure consistent implementation of internal requirements and external regulations and standards.
• Provide status reporting regarding manufacturing processes deliverable, dependencies, risks and issues, communicating across teams and management.
• Advise manufacturing and quality teams on the implementation of international standards (ISO 9001, regulatory standards, etc.) as they relate to manufacturing of product and Good Documentation Practices (GDP).
• Participate in the investigations and dispositions of product, non‑conformances and changes, CARs and MRB.
• Generate and maintain procedures, work instructions and forms, as necessary to ensure standardization of practices across Sani Sure.
• Implement required changes to existing training programs and assist in training staff members.
• Perform other tasks as assigned.

Quality engineering, Quality assurance, iso 13485, technical documentation, asq certified, asq certification, asq, capa, complaints, change control, root cause analysis, medical device, pharmaceutical, biotechnology, biotech, 21 CFR

• Bachelor’s degree in Business, Sciences or Engineering
• 5+ years of experience in quality operations within a biotechnology or pharmaceutical manufacturing facility.
• 5+ years of experience with technical documentation for complex activities in the areas of the Quality System that includes corrective actions, change control, quality audits and validation of manufacturing processes, or product development in a pharmaceutical or medical device environment.
• Strong understanding of global pharmaceutical and biotechnology product regulations with ISO 9001 and/or 13485:2003 and 21 CFR Parts 210 and 211 and/or Part 820.
• Able to drive continuous improvement through collaboration and consensus building.
• Proficient problem‑solving skills using continuous improvement tools; certification desired in ASQ, Green Belt, Lean, or equivalent.
• Demonstrated proficiency in multiple quality systems including exception management, change control, document control, product release, etc. with strong decision‑making skills utilizing risk management.
• Quality System Knowledge (e.g. ISO 9001, ISO 13485).
• Advanced skills with MS Office software are preferred.
• Able to lead change environment across multiple sites and customers globally.
• Able to communicate effectively, verbally and in writing, and demonstrate good interpersonal skills interdepartmentally and with external vendors, contractors, and customers.

Intermediate Level

This is a Permanent position based out of Camarillo, CA.

The pay range for this position is $90000.00 - $110000.00/yr. Medical, dental, 401k, sick pay, pto.

This is a fully onsite position in Camarillo,CA.

This position is anticipated to close on Feb 27, 2026.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccom for other accommodation options.