Sr. Quality Control Manager - Healthcare Packaging

Transcendia, INC.•Hebron, OH

About The Position

Transcendia is a leader in custom engineered materials for critical product components in a wide range of markets and applications. The company provides deep material science expertise, outstanding customer service through broad geographic coverage and trusted product reliability. The Sr Quality Control Manager is responsible for leading and maintaining the Quality Management System (QMS) for healthcare packaging and single use technology products manufactured from plastic film. This role ensures compliance with applicable regulatory requirements, customer specifications, and internal standards to support the production of safe, compliant, and high-quality packaging for healthcare and medical applications. The Sr Quality Control Manager partners closely with Operations, Engineering, R&D, Supply Chain, and Commercial teams to drive continuous improvement, risk management, and a strong culture of quality.

Requirements

Bachelor’s degree in Engineering, Quality, Chemistry, Materials Science, or a related technical field required
7+ years of progressive quality experience in manufacturing, preferably in: Healthcare, medical device, pharmaceutical, or regulated packaging environments
Plastic film extrusion, converting, or flexible packaging
Strong working knowledge of ISO 13485, ISO 15378, ISO 14644, FDA cGMP, and healthcare packaging requirements
Experience with audits (customer, regulatory, and certification bodies)
Proficiency in root cause analysis, CAPA management, and risk management tools
Strong analytical, problem-solving, and decision-making skills
Excellent written and verbal communication skills, with the ability to interact effectively with customers and regulators
Proficiency with quality systems software and Microsoft Office tools
Regulatory & Compliance Expertise
Attention to Detail and Risk Awareness
Leadership & Team Development
Customer Focus
Continuous Improvement Mindset
Cross-Functional Collaboration

Nice To Haves

Master’s degree preferred
3+ years of quality leadership or people management experience preferred

Responsibilities

Lead, maintain, and continuously improve the enterprise healthcare Quality Management System in compliance with applicable standards and regulations, including but not limited to: 1. ISO 13485 (Medical Devices – as applicable to packaging) 2. ISO 15378 (Primary Packaging Materials for Medicinal Products)
FDA cGMP (21 CFR Parts 210/211 and applicable sections of 820)
Customer-specific healthcare and pharmaceutical requirements
Ensure all quality processes, procedures, and records are properly documented, controlled, and followed.
Serve as the enterprise subject matter expert for regulatory and customer quality requirements related to healthcare packaging.
Lead internal audits, customer audits, and third-party certification audits; prepare the organization for successful outcomes.
Host regulatory and customer audits, ensuring timely and effective responses to observations and corrective actions.
Manage audit findings, CAPAs, and follow-up activities to closure.
Oversee product release, nonconformance management, deviation investigations, and corrective and preventive actions (CAPA).
Drive root cause analysis using structured problem-solving methodologies (e.g., 5 Whys, Fishbone, FMEA).
Ensure effective change management processes are followed for materials, processes, equipment, and suppliers.
Partner with Engineering and Operations on validation activities (process validation, IQ/OQ/PQ, as applicable).
Act as the primary quality interface for healthcare and medical customers.
Manage customer complaints, quality inquiries, and corrective actions with timely and professional communication.
Support customer qualification processes, technical reviews, and new product introductions (NPI).
Oversee supplier qualification, monitoring, and performance management for raw materials and services used in healthcare packaging and single use technologies.
Work with Supply Chain and Procurement to ensure supplier compliance with quality and regulatory requirements.
Lead, develop, and mentor the Quality team, fostering accountability, engagement, and professional growth.
Promote a proactive quality culture across enterprise healthcare operations, emphasizing right-first-time performance and risk-based thinking.
Use quality metrics and data analysis to drive continuous improvement initiatives and support operational excellence.