Senior Quality Engineer

Overview

WHAT IS TEKNIPLEX?

Tekni Plex Healthcare is a respected business partner that specializes in the manufacturing of medical and pharmaceutical packaging for companies around the world. We aim to deliver better patient outcomes by manufacturing products that allow for less invasive procedures, reduced pain, faster healing, and safer drug delivery. We are currently hiring for teammates in our Quality Department, located in Madison WI.

The Sr. Quality Engineer will be responsible for ensuring product and process quality across manufacturing operations in accordance with internal standards and external regulations (e.g., ISO 13485, FDA). This individual will drive continuous improvement initiatives, support quality system management, and work cross-functionally to resolve issues and maintain compliance.

• Quality Systems & Compliance:
  • Support the development, implementation, and maintenance of the Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, and customer-specific requirements
  • Participate in internal and external audits (e.g., FDA, ISO, customer)
• Process & Product Quality:
  • Perform root cause analysis and corrective/preventive action (CAPA) investigations
  • Review, approve and execute/support validation protocols, reports, and production documentation
  • Conduct quality inspections, audits, and statistical process control (SPC)
  • Create and maintain Failure Modes, Effects Analysis (FMEAs) for processes
  • Participate in and/or support supplier management process, including supplier approval, SCARs, audits, etc
• Documentation & Reporting:
  • Create and revise quality procedures, work instructions, and control plans for new and existing machines
  • Maintain accurate records of testing, inspections, and quality metrics
  • Maintain raw material and internal product specifications
• Continuous Improvement:
  • Lead or support Lean/Six Sigma and continuous improvement projects
  • Analyze process data to identify trends and areas for improvement
  • Lead or supplier management of change projects
• Cross-functional Support:
  • Collaborate with Engineering, Production, and Regulatory teams to ensure product quality throughout the development and manufacturing lifecycle.
  • Interface with customers on quality-related matters, including complaints and audits
• Other responsibilities:
  • Ability to support our other Business Unit plants, on an as needed basis
  • Ensuring all quality standards and procedures are maintained, including training and monitoring of new and existing employees in the processes and methods required to achieve the company’s standards for quality consistent with company principles
  • Overseeing the maintenance of related test equipment, including calibrations, repair, servicing ordering supplies, training personnel as needed
  • Other duties as assigned

• Bachelor’s degree in Engineering, Quality, or a related technical field
• 5+ years of experience in a quality engineering role, preferably in medical device, pharmaceutical, or regulated manufacturing environment
• Working knowledge of ISO 13485, FDA QSR, and GMP
• 6 Sigma Belt Certification-Preference of at least Green Belt Certification
• Proficiency in root cause analysis tools (e.g., 5 Whys, Fishbone, FMEA)
• Experience with statistical tools and software (e.g., Minitab, Excel)
• ASQ Certified Quality Engineer (CQE) or equivalent is a plus
• Strong interpersonal and communication skills
• Prior experience with Intelex
• Ability to work with production operators on the manufacturing floor

Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals. Ability to write routine reports and legibly complete time cards and work orders. Ability to read, analyze, and interpret technical procedures and read blueprints and technical drawings, such as machine, mechanical, pneumatic, hydraulic, and electrical. Ability to effectively present information in one-on-one and small groups situations to other employees of the organization.

Ability to effective present information and respond to questions form groups of managers, clients, customers, and the general public.