Quality Assurance Manager

Job Purpose Provides leadership for Permobil Seating and Positioning locations and functions in areas of regulatory compliance, quality assurance, and quality control by leading the department, establishing standards, solving quality issues, determining global regulatory requirements, documenting and reporting quality results, acting as the 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. Responsibilities 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 determining corrective action when necessary. Leads regulatory compliance efforts by developing, implementing, and overseeing compliance strategies and policies necessary to register, distribute, and sell company products within specified markets, and acting as the main contact with regulatory bodies (e.g., FDA). Provides strategic vision of the risk management process by guiding the refinement of the risk management documentation process, advising the QA/RC team in assessing and mitigating product and process risks, and reviewing and approving risk management documentation. Establishes raw material standards by evaluating product designs, determining risks associated with raw materials and components, interacting with Supplier Quality, and approving testing methods and procedures. Measures results by appraising, documenting, and reporting quality trends, problems, and issues, including post‑market feedback, and reporting QA/RC department activities on a regular basis. Establishes compliant quality management systems by acting as Management Representative and Person Responsible for Regulatory Compliance, managing QMS operations, internal auditing, product approval, post‑market feedback, document control, corrective and preventive action, and quality records. Ensures interdepartmental cooperation and support by reporting to the V.P. of QA/RC, supporting the product development process and production operations, and coordinating efforts with other production units and group functions. Increases management’s effectiveness by recruiting, selecting, orienting, training, coaching, counseling, and disciplining department employees, communicating values and objectives, and developing incentives. Accomplishes subsidiary objectives by establishing plans, budgets, and results measurements; allocating resources; reviewing progress; and ensuring documentation for design transfer activities. Education and Experience Bachelor’s Degree from college or university, plus a minimum of eight years related experience and/or training, including four years of professional experience in regulatory affairs or in quality management systems relating to medical devices. Recruiting Information Please apply via our career page. We will conduct selection continuously, so send us your application today. Equal Opportunity Employer At Permobil, diversity fuels our innovation in creating life‑changing mobility solutions. We embrace the unique talents and perspectives of individuals from all backgrounds. Permobil is an equal‑opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Please respect that we do not wish recruitment assistance or advertising; we decline calls from recruitment and advertising providers. More About Permobil Permobil founder Dr. Per Uddén believed that helping people achieve the greatest level of independence is a basic human right and, for over 50 years, Permobil has held fast to that belief. Permobil is a global leader in advanced rehabilitation technology, passionate about better understanding our users’ needs and improving their quality of life through state‑of‑the‑art healthcare solutions. Today, those solutions include power wheelchairs, seating and positioning products, power assist, and manual wheelchairs. Permobil is part of Patricia Industries, a subsidiary of Investor AB, and is headquartered in Sweden. Permobil has 1,900 team members in more than 18 countries around the world. For more information regarding the company’s history and product line, visit permobil.com. #J-18808-Ljbffr