What are the responsibilities and job description for the Quality Assurance Manager position at Permobil?
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.
Job Purpose
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.
Essential Job Results
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 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.
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; and approving testing methods and procedures.
Measures Results By
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.
Establishes Compliant Quality Management Systems By
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.
Ensures Interdepartmental Cooperation And Support By
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.
Increases Management’s Effectiveness By
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.
Accomplishes Subsidiary Objectives By
Establishing plans, budgets, and results measurements; allocating resources; reviewing progress; making mid-course corrections when needed; ensuring documentation is established for design transfer activities.
Education And Experience
Bachelor’s Degree from college or university, plus 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.
Why Permobil is a great next step for you!
Who You Are
You are passionate, innovative, and ambitious. You want to make a difference for others and feel fulfilled when you can see the link between the work you do and positive improvements in the lives of others. You search out opportunities and are prepared to go off the beaten track to chase your dreams. You don’t follow the herd – you find new ways of working and go where you see potential to make your mark. You are a pioneer, a revolutionary, a game-changer and you are who we’re looking for.
Information
Please apply via our career page. We will conduct selection continuously so send us your application today!
For information regarding Permobil's Privacy Notice, please visit Permobil Candidate Privacy Notice
At Permobil, diversity fuels our innovation in creating life-changing mobility solutions. We embrace the unique talents and perspectives of individuals from all backgrounds to drive our mission forward. Join Permobil and be part of a team where diversity is not just valued, but essential to our success in delivering personalized mobility solutions.
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.
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 1900 team members in more than 18 countries around the world. For more information regarding the company’s storied history and complete product line, visit permobil.com.
#HPPC
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.
Job Purpose
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.
Essential Job Results
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 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.
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; and approving testing methods and procedures.
Measures Results By
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.
Establishes Compliant Quality Management Systems By
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.
Ensures Interdepartmental Cooperation And Support By
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.
Increases Management’s Effectiveness By
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.
Accomplishes Subsidiary Objectives By
Establishing plans, budgets, and results measurements; allocating resources; reviewing progress; making mid-course corrections when needed; ensuring documentation is established for design transfer activities.
Education And Experience
Bachelor’s Degree from college or university, plus 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.
Why Permobil is a great next step for you!
- You’ll make a difference. Every day.
- You’ll make your mark as part of our future
- You’ll feel welcome from day one
- You can have a lifestyle you love
Who You Are
You are passionate, innovative, and ambitious. You want to make a difference for others and feel fulfilled when you can see the link between the work you do and positive improvements in the lives of others. You search out opportunities and are prepared to go off the beaten track to chase your dreams. You don’t follow the herd – you find new ways of working and go where you see potential to make your mark. You are a pioneer, a revolutionary, a game-changer and you are who we’re looking for.
Information
Please apply via our career page. We will conduct selection continuously so send us your application today!
For information regarding Permobil's Privacy Notice, please visit Permobil Candidate Privacy Notice
At Permobil, diversity fuels our innovation in creating life-changing mobility solutions. We embrace the unique talents and perspectives of individuals from all backgrounds to drive our mission forward. Join Permobil and be part of a team where diversity is not just valued, but essential to our success in delivering personalized mobility solutions.
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.
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 1900 team members in more than 18 countries around the world. For more information regarding the company’s storied history and complete product line, visit permobil.com.
#HPPC