Quality & Compliance Manager – Medical Packaging
| Company | Printpack |
|---|---|
| Location | Asheville, NC, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior |
Requirements
- Bachelor’s degree in technical/engineering discipline
- 5+ years professional experience
- ISO QMS standards experience, preferably ISO 13485
- Experience with CAPA, FMEA, and Change Control Management
- Background in medical, pharmaceutical, or highly regulated industries
- Proven track record in standardizing quality systems across facilities
- Strong leadership and communication abilities
- Strategic thinking and change management expertise
- Data-driven approach using ASQ methods
- Ability to build and implement business processes independently
- Excellence in stakeholder management and customer relations
Responsibilities
- Lead quality departments across two plants, managing a team of 22 including plant quality managers, quality engineers, and lab associates
- Develop and maintain ISO 13485 Quality Management System (QMS)
- Drive quality assurance strategies ensuring compliance with medical device and healthcare packaging requirements
- Standardize quality processes between facilities to deliver consistent, world-class product quality
- Oversee talent development and succession planning for quality organization
- Manage customer, internal, and regulatory body audits
- Execute Change Control Procedure (CCP) and validation processes
- Lead quality management review (QMR) sessions and data analysis
- With a Safety First focus, collaborate with cross-functional teams to drive continuous improvement
- Represent the business unit in corporate quality initiatives
- Lead quality discussions with customers and external partners
- Negotiate Quality Agreements with Customers and Suppliers to position Printpack Medical for growth
Preferred Qualifications
-
No preferred qualifications provided.