Quality Assurance Manager

Quality Assurance Manager

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
.

Provides leadership for Permobil Seating and Positioning locations and functions in areas of regulatory compliance, quality assurance, and quality control by leading department, establishing standards, solving quality issues, determining global regulatory requirements, documenting and reporting quality results, acting as Company's main contact with regulatory authorities, and acting as a primary customer liaison for quality issues. Ensures company compliance with applicable quality standards and regulatory requirements necessary to register, distribute, and sell products including ISO 13485, FDA QSR;

and EU regulations.

Oversees product quality and reliability by:

• Implementing company quality standards for products and manufacturing processes;
• Establishing company goals related to quality; ensuring conformance with product specifications;
• Evaluating the disposition of non-conforming material; utilizing statistical analysis and making appropriate 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 be used to improve outcomes.

Leads regulatory compliance efforts by:

• Developing, implementing, and overseeing compliance strategies and policies necessary to register, distribute, and sell company products within specified markets relative to production, distribution, record keeping, etc. of Company's products;
• Establishing and maintaining formal lines of communication with all departments and executive staff as it pertains to regulatory concerns;
• Acting as main contact with regulatory bodies (e.g. FDA) and authorized representatives;
• Ensuring documentation and company processes remain compliant as new requirements arise;
• Reviewing and preparing responses to customers and quality, regulatory, and other compliance authorities related to inquiries about how product design, manufacturing, registration, distribution and sales satisfy applicable requirements.

Provides strategic vision of the risk management process by:

• Fully understanding and communicating the risk management requirements of ISO 14971, ISO 13485, and European Medical Device Regulation 2017/745 and other regulations as they apply to the company's products and processes;
• Guiding the refinement of the risk management documentation process;
• Advising the Quality Assurance/Regulatory Compliance (QA/RC) team in assessing and mitigating product, process, and Quality Management System risks;
• Reviewing and approving risk management documentation, acting as a resource to other company functions for risk management activities.

Establishes raw material standards by:

• Evaluating product designs and assisting with the determination of key quality characteristics;
• Determining risks associated with raw materials and components in order to support manufacturing processes;
• Interacting with Supplier Quality when supplier quality related concerns arise;
• 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…