Quality Assurance Manager

Overview

Would you like to work in an international environment where you’ll make a difference every day? At Permobil, we’re looking for game-changers to join us as we innovate for individuals and develop the world’s most advanced assistive solutions.

At Permobil, the people who use our products come first. Our purpose is to create advanced assistive solutions that make the lives of adults and children living with disabilities more enriching. Our people are passionate about pushing the boundaries of technology to deliver innovations that improve lives. We are a sustainable and responsible business committed to continuous improvement, and our customers can trust us to provide market-leading solutions driven by insights-based clinical data.

Our Quality Assurance and Regulatory Compliance department in New Berlin, WI is now looking for a Quality Assurance Manager.

• Oversees product quality and reliability by implementing company quality standards for products and manufacturing processes; establishing goals related to quality; ensuring conformance with product specifications; evaluating the disposition of non-conforming material; utilizing statistical analysis and making specification changes when necessary; determining need for corrective action for product nonconformance, product performance, or customer feedback; enforcing quality assurance policies and procedures and government requirements;
  
  establishing best practices and systems to improve outcomes.
• Leads regulatory compliance efforts by developing, implementing, and overseeing compliance strategies and policies to register, distribute, and sell company products within specified markets; establishing formal lines of communication with all departments and executive staff regarding regulatory concerns; acting as main contact with regulatory bodies (e.g., FDA) and authorized representatives; ensuring documentation and processes remain compliant as new requirements arise; reviewing and preparing responses to customers and quality, regulatory, and other compliance authorities.
• Provides strategic vision of the risk management process by understanding and communicating ISO 14971, ISO 13485, European Medical Device Regulation 2017/745, and other applicable regulations; guiding refinement of the risk management documentation process; advising the QA/RC team in assessing and mitigating risks; reviewing and approving risk management documentation; serving as a resource to other functions for risk management activities.
• Establishes raw material standards by evaluating product designs and determining key quality characteristics; assessing risks related to raw materials and components; interacting with Supplier Quality for supplier-related concerns; approving testing methods and procedures.
• Measures results by appraising, documenting, and reporting quality trends, problems, and issues as they develop, including post-market feedback; reporting QA/RC department activities regularly.
• Establishes compliant quality management systems by acting as Management Representative under ISO 13485 and 21 CFR part 820 for the Belleville Site and as the Person Responsible for Regulatory Compliance under European Medical Device Regulation 2017/745 for Belleville and New Berlin locations; managing QMS operations including internal auditing, product approval, post-market feedback, document control, CAPA, and quality records; supporting calibration and process/software validation;
  
  drafting top-level policies and communicating requirements to all employees.
• Ensures interdepartmental cooperation and support by reporting to the VP of QA/RC; supporting product development and production operations; collaborating with process engineering to implement new equipment, tooling, and processes; coordinating with counterparts and management in other company sites, regions, and group functions.
• Increases management effectiveness by recruiting, selecting, orienting, training, coaching, counseling, and disciplining department employees; communicating values and objectives; planning, monitoring, and appraising results; developing incentives and a climate for feedback.
• Accomplishes…