Quality Manager

Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 130,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com. 

About Finland

Our Finland locations include Vantaa and Joensuu, employing over 750 professionals supporting functions such as production, instrument and reagent manufacturing, R&D, marketing, sales, quality, administrative support and supply chain. We hire experts in different engineering fields, chemistry, microbiology and bioinformatics. Our Joensuu factory with over 280 plastic industry professionals uses modern manufacturing processes utilizing robots to produce products for laboratories l- pipettes, pipette tips and other plastic consumables. Please read more at https://jobs.thermofisher.com/global/en/finland.

Take a look how our software professionals in Finland are enjoying our innovative work atmosphere and the role they are playing in helping humankind: https://youtu.be/wDm4NLxq3nI

How will you make an impact?

We are looking for an experienced Quality Manager in our Joensuu manufacturing site to ensure that the Quality Management System is effective and compliant with site specific set of requirements, standards and regulations e.g.  ISO 9001, ISO 13485, ISO 14001, and ISO 17025.

The responsibilities and authorities included, but are not limited to monitor, coordinate, manage and evaluate the quality management system processes including responsibility and authority to:

• Ensure the processes needed for the Quality Management System are effectively implemented, established, and maintained.
• Report to top management on the performance of the quality management system including needs for improvement.
• Liaison with external parties on matters relating to the Quality Management System.

What will you do?    

• Responsible for maintaining and improving the quality system in Joensuu to fulfill agreed requirements (e.g. ISO 9001, ISO 13485, and ISO 17025).
• Participating role in ensuring product and operations quality.
• Provide leadership to ensure that strategic and annual quality planning is integrated into strategic and operating plans.
• Acts as Management Representative of the Quality System, maintaining oversight of compliance through effective product and process quality reviews including Management Review.
• Is authorized to release product, stop production to mitigate, reduce risk or to prevent quality non-conformance, and to approve Permit of Exception’s.
• Is authorized to sign QMS and Product Certificates and Supplier Questionnaires, that are related to own responsible area and own or SME expertise after ensuring that objective evidence is available for stated claims.
• Leads the Corrective and Preventive Action Program.
• Leads all aspects of the Internal Audit program in assuring compliance with standards.
• Participates with Human Resources to assure training is available to all employees regarding the Quality System and the Quality Policy.
• Handles customer complaints process. Participate in global complaint process and works closely with product and production managers and if needed as agreed separately directly with customers to resolve issues.
• Leads Key Quality Business Metrics and Department Metrics.
• Participates actively in cost reduction and PPI projects.
• Acts as a manager for Quality Team.
• Other duties may be assigned, by Quality Director or senior management.

How will you get here? 

• Managerial role experience in ISO 13485 certified medical-device manufacturing company for at least 3 years.
• Bachelor’s degree (science, technology) or experience of similar job.
• Experience in quality system requirements; ISO13485 and 9001, auditing and problem-solving techniques.
• Good written and spoken English and Finnish, other languages are an advantage.
• Excellent ability to write documents and describe processes in Finnish and English.
• Good prioritization and organizing skills in a matrix organization.
• Skills in conducting discussions with international partners and being able to work effectively in global organization.
• Good social skills and consistent track record for developing and coaching employee team in a continuous improvement environment and passion for driving business improvement in a large, complex, and heavily matrix global organization.
• Skills to handle competing goals with confidence and integrity.
• Ability to operate and use IT tools, and willingness to coordinate development of IT tool solutions for effective management system.
• Skills in product/process validations applying various statistical principles to sample size determination and result assessment.

In addition to the exciting and versatile job, we offer:

• Compensation on various methods from annual bonus scheme to colleague recognition program
• Variety of occupational health care services and insurance
• Epassi leisure benefit
• Various hobby clubs with company sponsorship such as golf club, boating club, sport club etc.
• Possibility to take part in our charity work
• Career development and progression possibilities offered by our global network
• Our comprehensive training platform and programs
• Be part of our mission to enable our customers to make the world healthier, cleaner and safer

Please send in your application, including a cover letter, CV and salary request in English. Please apply via http://jobs.thermofisher.com/ by 7.4.2024. Reference: R-01225933. Please apply as soon as possible, the position will be filled as soon as suitable candidate is found.

If you have questions about Thermo Fisher Scientific and/or the position - please contact Luis Perez, Director, Quality, luis.perez@thermofisher.com.

About us:

Each one of our 130,000 extraordinary minds has a unique story to tell. It’s not just a career, it’s a chance to realise your best – professionally and personally.

Join us and contribute to our mission—enabling our customers to make the world healthier, cleaner and safer: http://jobs.thermofisher.com