Quality Manager (m/f/d) - #2120467

Trelleborg is a world leader in engineered polymer solutions that protect critical applications in demanding environments. Its innovative solutions accelerate performance for customers in a sustainable way. And we are where we are because our talents brought us here. In 2023, the Trelleborg Group had annual sales of approximately SEK 34 billion in around 40 countries. The Group comprises three business areas: Trelleborg Industrial Solutions, Trelleborg Medical Solutions and Trelleborg Sealing Solutions. The Trelleborg share has been listed on the Stock Exchange since 1964 and is listed on Nasdaq Stockholm, Large Cap. [www.trelleborg.com] (https://eur02.safelinks.protection.outlook.com/?url=http://www.trelleborg.com/&data=05%7c01%7cmaria.rifaut%40trelleborg.com%7c3b757bb991bb411d827708dba3044535%7c0f86117777224f068db93384e5321a9f%7c0%7c0%7c638283010950261273%7cUnknown%7cTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7c3000%7c%7c%7c&sdata=8TeIdPxJaN2pjtmrQi19WoTwOZDKNZxQKFP0DilDVgc%3D&reserved=0)

At Trelleborg Medical Solutions, we are dedicated to upholding outstanding standards in the medical field, and we encourage you to become part of our elite team. As a Quality Manager (m/f/d), you will be pivotal in ensuring our operations are flawless and strictly aligned with industry regulations. This opportunity allows you to craft the future of medical solutions and contribute to groundbreaking advancements!

What You´ll Be Doing

• Drive and conduct periodic reviews, supporting QMS initiatives while successfully implementing continuous improvement activities.
• Promote regulatory and customer requirements awareness throughout the organization.
• Establish and monitor the Quality Department’s goals and objectives to ensure excellence.
• Lead all aspects of processes that enable employees to implement and uphold Quality Systems covering:
• Corrective Action/Preventative Action System
• Quality Manual
• ISO Certifications
• Equipment/Software/Environmental Control System
• Non-conformance System
• Document and Record Control System
• Supplier Quality and Materials Control System
• Management Control System
• Customer Feedback/Control System
• ITAR (Empowered Official Responsibility)
• Quality Systems supporting Production and Process Controls
• Prioritize resources for new product reviews and handle customer correspondence related to projects or complaints.
• Manage documentation control and maintenance required by the Quality System.
• Develop, mentor, and coach Quality department employees, encouraging a culture of continuous improvement.
• Conduct annual internal audits on all relevant Quality Systems and represent Quality during Customer and Regulatory audits.
• Act as the Quality Management representative for the organization.
• Ensure site regulatory registrations are established and maintained.
• Lead and support Quality System integrations for organizational acquisitions.
• Support the integration of new manufacturing capabilities, product transfers, development programs, and customers.
• Promote and support a Quality Culture throughout the organization.
  
  

Required

What You bring:

• 4-year degree in manufacturing or industrial engineering, quality assurance, regulatory affairs, science, or a related field
• Proven experience in quality assurance and/or regulatory affairs
• More than 5 years in a Leadership/Supervisory role with significant decision-making authority
• In-depth knowledge and experience with GMP/ISO Standards: ISO 9000/9001, ISO 13485, FDA 21CFR 820/11 (4/210/211), and other relevant regulatory standards
• Experience in Class I, II, and/or III (or equivalent) medical device manufacturing, including components, assemblies, and finished medical devices.
• Auditor certification or equivalent experience with internal and external regulatory agencies
  
  

Desired

• Master’s degree or equivalent experience in science, engineering, or related field
• ASQ Certification for CQA, CQM, and Lean Six Sigma Black Belt Certification
• 5+ years in a Medical Device or Medical Device Supplier environment
  
  

Our Benefits For You

• Extensive induction training through Trelleborg Academy to help you get acquainted with our company, contacts, and structures
• A challenging and interdisciplinary field of activity that will keep you engaged
• Work in a multicultural environment that values diversity and inclusion
• A flexible work environment in our new innovation center to balance professional and personal life
• Diverse culinary options, as well as game, relaxation, and fitness zones for a healthy work-life balance
• Excellent public transport connections and a parking garage with free e-charging stations as part of our mobility concept
• Flexible working time models with the option for mobile work
  
  

#Startshapingindustryfromtheinside#

Trelleborg values diversity, celebrating employees' unique backgrounds and skills to drive innovation.