Quality Manager

Madison South
6002 Femrite Drive
Madison, WI 53718, USA

Tekni Plex is hiring a Quality Manager for our Madison, WI facility. The QA Manager is the appointed Management Representative for Quality with associated responsibilities and authority. This position has the Quality Authority for final disposition decisions of all materials and product. The Quality Manager reports directly to the Quality Director with a dotted line to the Plant Manager and has overall responsibility to make decisions and take action so that quality standards are maintained and continuously improved.

The salary range for this role is $108,000 to $162,000 annually.

• Manage site’s Quality Management System using Intelex (eQMS software)
• Evaluate KPIs by completing monthly and annual KPIs
• Drive improvements to ensure compliance to site’s quality objectives
• Responsible for assuring products meet internal and external quality requirements
• Coordinate Corrective Action activities
• Selection and maintenance of tools, inspection systems, and associated equipment
• Responsible for oversight of supplier quality, including supplier approval, complaints, and audits.
• The evaluation and review of quality requirements
• Communication with customers regarding complaints, change control, etc.
• ISO Management Representative;
  Responsible for QC participation/compliance with GMP and other programs.
• Participate in cross‑site internal audits of other Tekni Plex Healthcare locations
• Plan, host, and coordinate Internal, Customer, and annual ISO 13485 audits
• Supervisory oversight of quality team including performance management
• Responsible for participating in the facility’s Safety and Environmental programs to ensure a safe work environment.
• 5-10% Travel for cross‑site internal audits and/or supplier audits
• Promote worker safety by:
  • Actively assessing activities on a constant basis to ensure no unsafe actions or results will occur.
  • Stressing safe working practices as a condition of employment to associates.
  • Leading audit initiatives of employee behaviors to ensure compliance with safety rules and guidelines, as well as housekeeping audits and surveys.
  • Ensuring the housekeeping in the facility is maintained or improved to the highest level possible.
  • Ensuring that all corporate initiatives are followed as appropriate.
• Ensures Quality products and processes are maintained by:
  • Understanding and supporting both quality policies and the Quality System.
  • Performing work at a level that ensures quality of this position’s work meets or exceeds internal and external customer specifications.
  • Identifying and correcting, where possible, any identified quality issues throughout the plant.
  • Development and implementation of quality training.
  • Participating in system or quality‑based training provided or recommended by the company.
• Actively participates in the continuous improvement process by:
  • Identifying and addressing any opportunities to reduce cost, improve product repeatability & reliability.
  • Lead and/or champion CI teams to eliminate problems, streamline operations or other areas as defined by management.
• All other duties as assigned.

• Minimum 5+ years as Quality Manager or other leadership experience in a manufacturing environment within a regulated industry, or equivalent combination of education and experience
• Minimum 3 years of supervisory experience
• Minimum 3 years of flexible packaging experience or equivalent preferred
• Experience managing eQMS (e.g., Intelex) activities
• Previous ISO and GMP experience required, preferably ISO 13485
• Knowledge of FDA requirements (21 CFR)
• Medical device experience is a plus
• Microsoft products (Excel)
• ERP and other planning software
• Minitab
• Basic understanding of quality equipment, instruments, and processes
• Strong communication and interpersonal skills (internal and external)
• Must have the ability to develop and lead an accountable team
• Strong negotiation and conflict resolution skills
• Strong attention to detail
• Must be self‑motivated

• Medical Coverage
• Prescription Drug Coverage
• Vision Coverage
• Employee Assistance Program
• Health Savings Account (HSA)
• Flexible Spending Account (FSA)
• Basic Term Life/AD&D Insurance
• Voluntary…