Jobbeschreibung
Quality Manager (m/f/d)
Trelleborg is a world leader in engineered polymer solutions for almost every industry on the planet. And we are where we are because our talents brought us here. By specializing in the polymer engineering that makes innovation and application possible, Trelleborg works closely with leading industry brands to accelerate their performance, drive their business forward—and along the way, shape the industry and progress that will benefit humankind in the exciting years ahead. Our people are Shaping Industry from the Inside. Why don´t you join us?
Location
Stuttgart
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!
- Drive and conduct periodic reviews, supporting QMS initiatives while successfully implementing continuous improvement activities.
- 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)
- 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.
- Lead and support Quality System integrations for organizational acquisitions.
- Support the integration of new manufacturing capabilities, product transfers, development programs, and customers.
Required:
- 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
- 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