Site Quality Manager

The QMR (Quality Management Representative) for Power products in Timrå is responsible for ensuring that the QMS (Quality Management System) applicable for the site is effective and performance routinely assessed. This includes ensuring that local needs are met, site-specific SOP/WI/forms are in place where needed, as well as ensuring alignment with the regional QMS and product quality. We are now looking for Site Manager Quality who will lead site QA team and be able to be PRRC (where site 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, 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 as well as champion our Quality Policy - Quality Counts.
Key Duties
Lead site Quality team
PRRC (where site legal manufacturer)
QA support for site functions incl Operation, Production, Supply Chain, R&D incl design and development.
Ensure that assigned QMS processes are compliant to all applicable regulatory requirements medical device (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 coordinates audits/inspections
Act as internal auditor
Your background:
Master degree or Bachelors 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
Able to be PRRC for products (where site legal manufacturer)
Previous experience of ensuring QMS processes are compliant to all applicable regulatory requirements medical device (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)
Strong computer skills including Microsoft Office
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 details and problem-solving capabilities are also key together with having the ability to develop efficient processes.
More information:
Location is in Sundsvall/Timrå and we offer hybrid workplace.
For more information about the position, please contact Monika Östlund, VP QA/RC EMEA at monika.ostlund@permobil.com
For questions about the recruitment process, please contact Maria Myrén HRBP Nordics & UK at maria.myren@permobil.com
For unions related questions, please send an email to unionen@permobil.com
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 1600 team members in more than 15 countries around the world. For more information regarding the company’s storied history and complete product line visit permobil.com.