Sr. Quality Control Manager - Healthcare Packaging

Sr. Quality Control Manager - Healthcare Packaging Transcendia, Inc. 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. Position Summary 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. Key Responsibilities Quality Management System (QMS) & Compliance Lead, maintain, and continuously improve the enterprise healthcare Quality Management System in compliance with applicable standards and regulations, including but not limited to: ISO 13485 (Medical Devices – as applicable to packaging) 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. Audits & Regulatory Readiness 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. Product Quality & Risk Management 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). Customer Quality & Complaint Management 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). Supplier Quality 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. Leadership & Continuous Improvement 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. Education & Experience Bachelor’s degree in Engineering, Quality, Chemistry, Materials Science, or a related technical field required. Master’s degree preferred. 7+ years of progressive quality experience in manufacturing, preferably in healthcare, medical device, pharmaceutical, or regulated packaging environments. Experience with plastic film extrusion, converting, or flexible packaging. 3+ years of quality leadership or people‑management experience preferred. Knowledge & Skills 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. Key Competencies Regulatory & Compliance Expertise Attention to Detail and Risk Awareness Leadership & Team Development Customer Focus Continuous Improvement Mindset Cross‑Functional Collaboration Transcendia is an equal opportunity employer and will consider all candidates for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law. #J-18808-Ljbffr SupportFinity™