Manager, Quality – UPM, The Biofore Company, Helsinki
30.12.2022https://www.linkedin.com/jobs/view/3391738490
About the job
Are you looking to join a dynamic, innovation-driven, international company, building a better future for us all? UPM leads the forest based bioindustry into a sustainable, innovation-driven, and exciting future. The competence, integrity and drive of our people make us unique. We live by our values – trust and be trusted, achieve together, renew with courage.
We are now looking for a Quality Manager to join our Biomedicals team in Helsinki or Lappeenranta, Finland.
Greetings from your future colleagues
“We are looking for a diligent professional with a solid experience in ISO 13485 to maintain our QMS and also to help leading the implementation of FDA and GMP compliance.” – Johana Kuncová-Kallio, Director, Biomedicals
“UPM proprietary nanocellulose technologies open a wide range of business opportunities in the biomedical field. Together with our professional and enthusiastic team, you will play a key role in securing the product quality and regulatory compliance and also have a possibility to participate in new business development.” – Kari Luukko, Director, QA Biomedicals
What You’ll Do
- You share the vision for our products and for your part are responsible for its high-quality execution, the strategy implementation, and the roadmap development
- You maintain and develop our ISO 13485 quality management system (QMS) in accordance with applicable regulations
- You manage and develop QMS processes such as annual planning, non-conformities (NC) treatment, CAPA, change control and supplier management
- You manage the process of legislation and standards monitoring
- You maintain and develop UPM Biomedicals’ QMS database
- You support and steer the team members in daily quality operations such as quality control, document management, NC and CAPA processes, design and development
- You plan and co-ordinate management reviews, personnel trainings, as well as internal and external audits
- You are the main contact for our notified body
- You will be responsible for regulatory compliance on general level and support our teams in product-specific compliances. You will also participate in risk management processes of our products
- You manage the regulatory strategy process of our products’ global market expansions and collaborate with our business developers and product managers
Who You Are
- You have a university science degree and minimum if 5 years in a managerial role within quality management systems and regulatory affairs with focus to medical devices, ideally biomaterials rather than diagnostics or software
- You have a deep understanding and working knowledge of ISO 13485, QC, GMP, MDR and FDA practices and document management. Your documentation practices are exact and persistent
- You have proven business acumen and working knowledge of the industry and supplier base
- You have excellent communication and problem solving skills
- You are positive thinking, solution oriented, multitasking, persistent and proactive team player
- You are fluent in written and spoken English. Finnish is seen as a benefit
- Seen as a benefit:
- You have previous experience of medical device or in vitro medical device product development for the Clinical market
- You have previous experience in management of clinical trials
- You know medical device registration processes in different territories
This Is What We Offer For You
- Meaningful job: We are proud of what we do. Our work highlights the expertise of our personnel, the high quality of our products and the company’s values.
- Inspired and motivated teams: We have highly skilled workforce. We are a multifaceted, international organisation that works as a team to achieve our shared objectives.
- Development opportunities: With us you can build up your expertise. We provide opportunities to support your development throughout every stage of your career.
- Responsibility for people and environment: Our ethical principles embrace people as well as the environment. We are always striving to build a more sustainable future.
Additional Information
At the beginning (first 2 years), the job requires intensive presence in Finland (Lappeenranta or Helsinki) to adapt Biomedicals operations, later the location is negotiable in UPM sites in Europe.The recruitment will be done in cooperation with our recruitment partner George James Ltd.For more information, please contact Kari Luukko, Director, QA Biomedicals on +358400259866 at the following times:
- December 15th 2022 9-11 a.m. EET
- January 5th 2023 from 9-11 a.m. EET
- January 12th 2023 from 9-11 a.m. EET
Please send your application via link latest by 15.01.2023. We will start going through the applications already during application period so please submit your application as soon as possible.For support with submitting your application, please contact the HR Service Center at careers@upm.com or tel. +358204146600.A security background check may be performed for those selected to UPM positions, in accordance with the company recruitment guidelines and the Security Clearance Act 726/2014.UPM is a non-smoking workplace in Finland.
UPM Biomedicals is the forerunner in producing high quality nanofibrillar cellulose for medical and life science applications. More than 300 patents protect the existing and future products that rely on the Finnish birch pulp. We actively collaborate with universities, research centres and key industrial partners on innovations and products in the field of high throughput drug screening, personalized medicine, advanced cell therapies, 3D bioprinting, tissue engineering and wound care. www.upmbiomedicals.com