Site Quality Manager

2 days ago

Sundsvall, Sweden TN Sweden Full time

Would you like to work in an international environment where you will make a difference every day? We are 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.

Position overview

We are now looking for Site Manager Quality who will lead the site QA team and qualify to serve as the Person Responsible for Regulatory Compliance (PRRC) where the site is the legal manufacturer. In this role, you will develop and manage the local QA team as well as assigned processes within the QMS, support the organization to continuously improve quality of both products and QMS, and oversee operational activities such as reviewing and approving quality documents including but not limited to design and technical docs, risk assessments, and records. As QA support for related functions, you will also participate in projects, aid the organization to meet regulatory requirements, and champion our Quality Policy - Quality Counts.

This role is based on-site at Permobil's brand new cutting-edge innovation center in Birsta, Sundsvall, at the state-of-the-art facility, which unites research, manufacturing, and sustainable practices under one roof. Our commitment is to cultivate an inclusive environment that enhances accessibility, participation, and the development of world-class mobility solutions for the future.

Key responsibilities:

  • Lead site Quality Team,
  • PRRC (where the site is the legal manufacturer),
  • QA support for site functions including Operation, Production, Supply Chain, R&D including design and development,
  • Ensure that assigned QMS processes are compliant with all applicable regulatory requirements for medical devices (Class I EMA & Class II US) in accordance with MDR 2017/745, ISO13485, and FDA cGMP regulations 21 CFR part 820,
  • Review the implementation and efficiency of QMS processes within the organization working together with stakeholders,
  • Function as process responsible / process owner for assigned QMS processes,
  • Support quality reporting, KPI collection, and assessment,
  • Host and coordinate audits/inspections,
  • Act as internal auditor.

Your background:

  • Master's degree or Bachelor's degree preferably in science and engineering
  • Good knowledge of quality systems, quality assurance, and regulatory standards within the Medical Device or Pharma industry (preferably within Medical Device)
  • At least 5 years of working experience in a similar role
  • Able to be PRRC for products (where the site is the legal manufacturer)
  • Previous experience of ensuring QMS processes are compliant with all applicable regulatory requirements for medical devices (Class I EMA & Class II US) in accordance with MDR 2017/745, ISO13485, and FDA cGMP regulations 21 CFR part 820 for EMEA (meritorious)
  • Good knowledge of risk management (ISO 14971:2019)
  • Fluent in English and Swedish both oral and written

To succeed in this role, you have personal drive and natural characteristics of great leadership and communication skills. Attention to detail and problem-solving capabilities are also key together with the ability to develop 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 change around the world.
  • You'll feel welcome from day one.
    We're known for being great colleagues, who are collaborative, fun, and at the cutting-edge. Everyone at Permobil cares as much as you do about making a positive difference.
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