Site Quality Head
EPM Scientific · Hauppauge, NY · 3 days ago
On-siteEngineeringFull-time
What You'll Do
- Quality Leadership & Compliance: Serve as the site's Quality Management Representative, leading QA/QC, Quality Engineering and Quality Laboratory functions to ensure regulatory compliance, customer satisfaction and alignment with organizational goals.
- Quality Management System (QMS): Implement, maintain and optimise the QMS, ensuring procedures, work instructions and IT systems support site operations and drive continuous improvement.
- Strategic Partnership & Advocacy: Collaborate with site and global leadership to address process changes, advocate for site-specific needs, and drive customer-centric solutions during change management and product development.
- Team Development & Performance: Build a high-performing quality department, fostering a safe, empowering environment that encourages skill development, psychological and physical safety, and continuous improvement.
- Audits, Reporting, Risk & Representation: Lead Quality Management Reviews, define and monitor KPIs, host audits, lead risk assessments, and represent the site in executive discussions and global best-practice initiatives.
What You'll Bring
- Bachelor's degree, ideally in Science or Engineering - or 10+ years of equivalent experience within a regulated manufacturing environment.
- At least 7 years' experience in Quality, Quality Engineering or Manufacturing Operations within Life Sciences, Biotechnology, Medical Device, Biopharma or another FDA/EPA-regulated environment.
- Minimum 5 years' leadership experience, with 2 years leading both Quality Engineering and Quality Laboratory teams preferred.
- Strong knowledge of ISO 9001 & ISO 13485, FDA regulations, cGMPs and CFR requirements, including operational controls, validation, CAPA, complaints, audits and risk management.
- Proficiency in quality statistical methods, Lean Manufacturing, Six Sigma, Gage R&R and Root Cause Analysis tools to drive data-driven decisions.
- Proven ability to lead, coach and mentor teams, manage performance, plan succession and communicate effectively at all levels.