Permobil · 10 hours ago
Quality Assurance Manager
New Berlin, WI
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expPermobil is a global leader in advanced rehabilitation technology, and they are seeking a Quality Assurance Manager to provide leadership in regulatory compliance and quality assurance. The role involves overseeing product quality, leading compliance efforts, and ensuring the company meets applicable quality standards and regulatory requirements.
Health CareInnovation ManagementManufacturing
Responsibilities
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
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
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 any 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
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
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; and approving testing methods and procedures
Appraising, documenting, and reporting of quality trends, problems, and issues as they develop, including post-market feedback; reporting QA/RC department activities on a regular basis
Acting as Management Representative as defined by ISO 13485 and 21 CFR part 820 for the Belleville Site and acting as the Person Responsible for Regulatory Compliance as defined in European Medical Device Regulation 2017/745 for Belleville and New Berlin manufacturing locations; Managing the operation of QMS systems including internal auditing, product approval; post-market feedback; document control, corrective and preventive action, and quality records; supporting the operation of QMS systems including calibration and process and software validation; authoring top level policies and effectively communicates requirements to all employees
Reporting to the V.P. of QA/RC; supporting the product development process and production operations; working closely with the process engineering team to implement new equipment, tooling, and processes and to optimize existing equipment and processes; coordinating efforts with counterparts and management in other Company production units, regions, and group functions
Recruiting, selecting, orienting, training, coaching, counseling, and disciplining department employees; communicating values, strategies, and objectives; assigning accountabilities; planning, monitoring, and appraising job results; developing incentives; developing a climate for offering information and opinions; providing educational opportunities
Establishing plans, budgets, and results measurements; allocating resources; reviewing progress; making mid-course corrections when needed; ensuring documentation is established for design transfer activities
Qualification
Required
Bachelor's Degree from college or university
Minimum of eight years related experience and/or training
Four years of professional experience in regulatory affairs or in quality management systems relating to medical devices
Understanding and communicating the risk management requirements of ISO 14971, ISO 13485, and European Medical Device Regulation 2017/745
Leadership in regulatory compliance, quality assurance, and quality control
Establishing standards and solving quality issues
Documenting and reporting quality results
Acting as Company's main contact with regulatory authorities
Ensuring company compliance with applicable quality standards and regulatory requirements
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 improve outcomes
Developing, implementing, and overseeing compliance strategies and policies
Establishing and maintaining formal lines of communication with all departments and executive staff
Acting as main contact with regulatory bodies (e.g. FDA)
Ensuring documentation and company processes remain compliant as new requirements arise
Reviewing and preparing responses to customers and quality, regulatory, and other compliance authorities
Managing the operation of QMS systems including internal auditing, product approval, post-market feedback, document control, corrective and preventive action, and quality records
Supporting the operation of QMS systems including calibration and process and software validation
Authoring top level policies and effectively communicating requirements to all employees
Recruiting, selecting, orienting, training, coaching, counseling, and disciplining department employees
Communicating values, strategies, and objectives
Assigning accountabilities
Planning, monitoring, and appraising job results
Developing incentives
Developing a climate for offering information and opinions
Providing educational opportunities
Company
Permobil
Permobil creates assistive solutions that enrich the lives of people living with disabilities.
1001-5000 employees
H1B Sponsorship
Permobil has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (11)
2023 (3)
2022 (2)
2020 (3)
Funding
Current Stage
Late StageTotal Funding
unknown2013-03-27Acquired
Leadership Team
Chuck Witkowski
Chief Executive Officer
Charlotta Nyberg
Group Chief Financial Officer
Recent News
2025-10-28
AstuteAnalytica India Pvt. Ltd.
2025-10-23
Company data provided by crunchbase