Job Description

My client is a global CDMO in regenerative medicine, offering a differentiated portfolio of allograft and xenograft biomaterials at scale. As their Senior Quality Engineer, you will lead quality assurance initiatives across a manufacturing facility and supervise the QA Engineering team. The work spans validation, risk management, continuous improvement, and cross-functional product development at a company with real depth and global reach.

Why you should apply

• Lead and grow a QA Engineering team with real influence over hiring, performance, and how the function develops
• Cross-functional role with visibility into product launches, regulatory submissions, and manufacturing improvement across a fast-growing regenerative medicine CDMO
• Preferred certifications (ASQ CQE/CQA/CBA, Lead Auditor, AATB/CTBS) are recognized and valued

What you'll be doing

• Serve as a lead member of cross-functional teams coordinating deliverables for manufacturing process improvement
• Supervise the QA Engineering team, including performance management, corrective action, and hiring
• Review quality KPI data and drive continuous improvement across operations value streams
• Review validations and risk management activities supporting regulatory submissions and product launches
• Lead nonconformance investigations, change management workflows, and continuous improvement initiatives

About you

• Be able to do the job as described.
• Hands-on experience with test method validation, including sampling plan development and validation layout across multiple TMV types
• Background with Class II and/or Class III medical devices
• Experience supporting design to manufacturing transfers
• Track record of coaching or mentoring junior quality engineers