Quality Engineer

We are seeking a highly motivated Quality Engineer to support and drive quality performance across the manufacturing of single-use bioprocessing components used in biopharmaceutical production.

This role will be responsible for leading quality investigations, driving continuous improvement initiatives, and ensuring compliance with GMP and regulatory standards. The ideal candidate will collaborate cross-functionally with Manufacturing, Engineering, R&D, Supply Chain, and Regulatory teams to resolve quality issues and enhance product and process performance.

• Lead investigations related to product nonconformances, customer complaints, sterility concerns, and in-market quality issues
• Perform root cause analysis and implement Corrective and Preventive Actions (CAPA)
• Conduct risk and impact assessments and ensure timely closure of quality events
• Partner with cross-functional teams to identify failure modes and implement process improvements
• Support customer audits, supplier audits, and regulatory inspections
• Drive continuous improvement initiatives using Lean, Six Sigma, SPC, PFMEA
  , and other tools
• Improve manufacturing processes such as cleanroom assembly, extrusion, molding, and packaging
• Ensure compliance with GMP, ISO standards, and regulatory requirements
• Monitor quality metrics and report performance trends and risks to leadership
• Support change control, validation activities, and risk management processes
• Develop and maintain quality documentation, procedures, and training materials

• Bachelor’s degree in Engineering, Biological Sciences, Chemistry, Bioprocess Engineering, or related field
• 5+ years of experience in quality within biotech, pharmaceutical, medical device, or related manufacturing
• Experience working in GMP and/or cleanroom environments
• Strong knowledge of quality systems: CAPA, nonconformances, change control, validation, and risk management
• Familiarity with ISO 9001, ISO 13485
  , and/or FDA regulations (21 CFR Parts 210, 211, or 820)
• Experience with continuous improvement methodologies (Lean, Six Sigma, SPC, PFMEA)
• Strong problem-solving, analytical, and communication skills
• Ability to work cross-functionally and lead initiatives across multiple teams
• Experience with extrusion, injection molding, sterile manufacturing, or packaging processes
• Strong technical writing and documentation skills
• Proven ability to manage multiple priorities in a fast-paced environment
• Impact critical products used in biopharmaceutical manufacturing
• Work in a highly regulated, high-quality environment
• Collaborate with cross-functional global teams
• Be part of a culture focused on continuous improvement and innovation