JOB DESCRIPTION
Title: Complaints Specialist
Department: Quality
Reports To: Quality Director
Job Summary
The Complaints 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 Complaints 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 role is responsible for root cause analysis, CAPA implementation, and continuous improvement initiatives to ensure product quality, sterility assurance, and regulatory compliance.
Essential Functions
- 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 activities, and continuous improvement initiatives related to manufacturing processes and product quality.
- Perform other duties as assigned.
Education
Bachelor’s degree in Engineering, Biological Sciences, Bioprocess Engineering, Chemistry, or related technical field.
Required Experience & Competencies
- 5+ years of experience in quality operations within biotechnology, pharmaceutical, medical device, or single-use technology manufacturing.
- Experience working in GMP or cleanroom manufacturing environments.
- Strong experience with quality systems including CAPA, change control, nonconformance management, document control, product release, validation, and risk management.
- Strong understanding of ISO 9001 and/or ISO 13485 and applicable regulatory standards such as 21 CFR Parts 210, 211, and/or Part 820.
- Experience driving continuous improvement through Six Sigma, Lean Manufacturing, SPC, PFMEA, or similar methodologies.
- Experience supporting manufacturing processes such as extrusion, molding, cleanroom assembly, packaging, sterilization, or related manufacturing processes.
- Ability to lead cross-functional projects across multiple sites, suppliers, and customers globally.
- Strong technical writing, documentation, communication, and problem-solving skills.
- Proficiency in Microsoft Office applications.
- Ability to work effectively and efficiently in a team environment and lead change across multiple departments.
