Quality Manager EMEA
Permobil
QUALITY MANAGER EMEA
Would you like to work in an international environment where you will make a difference every day? We are looking for passionate individuals 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.
Position overview
As theQuality Manager Imported Products and S&P (Seating & Positioning)in EMEA, you will play a pivotal role in ensuring continued compliance and improved efficiency as part of continuous improvements of the QMS (Quality Management System) as well as ensuring product compliance and safety. This position is essential to uphold product safety and compliance throughout the entire product lifecycle including specific requirements for economic operators within the EU. You will lead and develop quality initiatives within the areas of the postition, acting as the key driver for fostering a culture of excellence in quality and regulatory compliance. Additionally, you will drive improvement efforts, optimizing processes to ensure both efficiency and adherence to quality standards.
This is a hybrid-remote role, you are welcome to join us form the below locations:
Sweden – Stockholm, Sundsvall
Netherlands – Oisterwijk
Key responsibilities:
+ Serve as Site Quality Manger and QMR (Quality Management Representative) for Supportec, V-Trak, as well as QMR for imported products, ensuring collaboration with sites responsible for design and development as well as manufacturing and other stakeholders to drive quality and regulatory actions.
+ As QMR for Imported products ensure imported products meet EMEA regional and country-specific requirements.
+ Oversee adherence to Economic Operator requirements and support import and distribution sites in fulfilling these obligations.
+ Support design control/assurance for sustaining and new product development, including clinical evaluations, to ensure products in above scope comply with regional specifications.
+ Oversee site quality reporting, including local and regional KPIs and Management Reviews.
+ Align, implement, and manage EMEA/site-specific QMS processes, including audits, CAPA, and risk management.
+ Lead QA improvements, training, and support for compliance on regulatory and quality matters.
+ Act as internal auditor and coordinate audits with external providers, ensuring follow-up on corrective actions.
Your background:
+ Master degree or Bachelor degree preferably in science and engineering
+ Minimum 5 years of working experience; Fulfill PRRC requirements according to MDR Article 15
+ Previous experience from Med Tech or Pharma industry and knowledge of applicable regulatory requirements and guidelines (MDR 2017/745, ISO13485 and FDA cGMP regulations 21 CFR part 820)
+ Good knowledge of quality systems and quality assurance within regulated industry (preferably medical device or pharma) and knowledge of applicable regulatory requirements and ISO. Understanding of ISO13485, 14971 key.
+ Understanding of requirements for importing into EU and the Economic Operator obligations (meritorious)
+ Capability in being a manager, leading operations with or without personnel responsibility
+ Strong collaboration and communication skills
+ Fluent in oral and written English, knowledge of Swedish is meritorious
+ Strong computer skills including Microsoft Office
To succeed in this role, you have personal drive and natural characteristics of great leadership and communication skills. Attention to details and problem-solving capabilities are also key along with developing efficient processes.
Why is Permobil the next step for you?
+ You’ll make a difference. Every day.
Everything we do leads to understanding and improving the lives of our users. Through our evidence-based innovation, we make a difference to people’s lives.
+ You’ll make your mark as part of our future.
We collaborate with colleagues across borders to Innovate for Individuals. The impact you make personally could lead to changes around the world.
+ You’ll feel welcome from day one.
We’re known for being great colleagues, who are collaborative, fun and at the forefront. Everyone at Permobil cares as much as you do about making a positive difference.
Application Process
We will conduct selection continuously so send us your application today or beforeFebruary 28th at the latest!
Permobil is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals.
For more information about the position, please contact Monika Östlund, VP QA/RC EMEA at monika.ostlund@permobil.com
For information about the recruitment process, please contact Zivile Mitkute, Talent Acquisition Partner, zivile.mitkute@permobil.com
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 2000 team members in 18 countries around the world. For more information regarding the company’s storied history and complete product line, visit permobil.com
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