Quality & Compliance Manager, Medical Packaging

Reporting to the Business Unit Director of Operations, the Quality & Compliance Manager serves as the quality subject matter expert (SME) for Printpack Medical, providing vision and direction for quality consistency and performance across facilities in Marshall, NC and Tijuana, Mexico. The Quality & Compliance Manager must be located in the regional vicinity of either the Marshall or Tijuana plant.

Primary 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

Required Qualifications: 

• Technical acumen and engineering problem-solving capabilities gained through education, training, or hands-on 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 

Required Skills: 

• 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 

Impact: 

This role is crucial in fostering a culture of quality assurance and safety while driving operational excellence across Printpack Medical's manufacturing facilities and partner networks. 

 

Printpack is proudly an equal-opportunity employer. We are committed to creating an inclusive environment. Embracing diversity enhances our work culture and is vital to our success. We do not discriminate based on race, color, religion, sex (including pregnancy), national origin, gender identity, sexual orientation, marital/parental status, genetic information, age, national origin, ancestry, ethnicity, disability, marital status, military or veteran status or affiliation, or any other characteristic protected under applicable law.

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