Lead Site Quality Manager
Lead all aspects of site quality, including QA, QMS, QC, and supplier quality oversight. Ensure compliance with ISO 13485 and regulatory standards in a cleanroom setting. Oversee manufacturing quality across extrusion, silicone molding, and electromechanical assembly. Build, lead, and develop a high-performing quality team (~10-11 employees). Partner cross-functionally with operations, engineering, and supply chain leadership. Drive continuous improvement initiatives and maintain audit readiness. Establish and maintain robust quality systems aligned with global standards.
Bachelor's degree in Engineering or a scientific discipline. Proven experience as a Site Quality Manager with full ownership of quality. 5-10+ years of leadership experience managing quality teams. Background in medical device manufacturing (required). Strong expertise in ISO 13485 and regulated environments. Hands-on experience with cleanroom manufacturing. Preferred: experience in electromechanical assembly, silicone molding, or extrusion. Pharmaceutical experience is a plus.
Competitive annual salary ranging from $150,000 to $180,000 USD. High visibility role reporting into senior global leadership. Opportunity to shape site quality strategy from an early stage. Strong compensation package with bonus potential. Work in a sustainable, LEED Gold-certified facility with cutting-edge technology.
Sector: Engineering & Manufacturing
Sub Sector: Quality, Technical
Industry: Industrial / Manufacturing
Where: Ayer
Contract Type: Permanent
| Location | Ayer, Massachusetts |
| Job Type | Full-time |
| Industry | Staffing/Employment Agencies |
| Salary | $150,000–$180,000 Per Year |
| Company Size | 10,000 employees or more |
| Website | https://www.michaelpage.ca/ |
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