Quality Engineer - Complaints

Quality Engineer
- Complaints

Regular
- Full Time Camarillo, CA, US

5 days ago Requisition

Salary Range: $95,000.00 To $ Annually

Sani Sure is a high-growth multinational manufacturer of single-use products and systems used in the production of biological drugs, including cell therapies, gene therapies, and vaccines. With operations in the U.S. and Europe, we supply global pharmaceutical and biotech companies with the critical tools they need to develop and manufacture some of today’s most innovative and life-changing medicines.

As we continue to expand our product offerings and global footprint, Sani Sure offers an exciting opportunity to join a nimble, customer-focused company at the forefront of the biotech industry.

The Quality Engineer works closely with Operations, Manufacturing Engineering, R&D, Supply Chain, and Quality teams to drive quality performance across the manufacturing of single-use bioprocessing components, tubing, molded components, and single-use assemblies used in biopharmaceutical manufacturing. The Quality Engineer will lead quality investigations, drive process improvements, support GMP manufacturing quality systems, and serve as the primary quality contact for manufacturing nonconformances, customer complaints, and in-market product issues.

The Quality Engineer is responsible for root cause analysis, CAPA implementation, and continuous improvement initiatives to ensure product quality, sterility assurance, and regulatory compliance.

• Lead quality investigations related to customer complaints, in-market defects, sterility concerns, particulate issues, and product nonconformances, including root cause analysis and implementation of corrective and preventive actions (CAPA).
• Conduct impact and risk assessments related to product quality issues and ensure timely closure of quality events in accordance with Quality Management System requirements.
• Collaborate with Manufacturing, Engineering, R&D, Supply Chain, and Regulatory teams to investigate failure modes, implement corrective actions, and support product and process changes through change control processes.
• Interface with biopharma customers and suppliers to address product or manufacturing nonconformances and support customer audits, supplier audits, and regulatory inspections.
• Lead process improvement initiatives utilizing Statistical Process Control (SPC), Six Sigma, Lean Manufacturing tools, 5S, Value Stream Mapping, Control Plans, PFMEA, and Process Mapping to improve manufacturing processes and product quality.
• Improve and support manufacturing processes related to cleanroom assembly, tubing extrusion, injection molding, packaging and sealing, sterile barrier systems, and lot traceability to ensure consistent product quality and sterility assurance.
• Lead Manufacturing Quality Assurance initiatives to ensure process flows are effective, controlled, and compliant with internal quality systems, GMP expectations, ISO standards, and customer requirements.
• Provide guidance to manufacturing and quality teams on root cause and corrective action activities and recommend process improvements to ensure consistent implementation of internal requirements and external regulations and standards.
• Monitor process performance metrics and quality trends and provide status reporting regarding manufacturing processes, deliverables, risks, and improvement initiatives to management.
• Advise manufacturing and quality teams on the implementation of international standards and Good Documentation Practices (GDP) as they relate to manufacturing and quality system requirements.
• Participate in investigations and dispositions of product nonconformances, change controls, corrective action requests (CARs), and Material Review Board (MRB) activities.
• Generate and maintain procedures, work instructions, forms, and quality system documentation to ensure standardization of practices across the organization.
• Implement required changes to existing training programs and assist in training staff members on quality procedures, process changes, and documentation practices.
• Support validation activities, risk management…