Product Care Manager (m/f/d) - Research and Development

Stryker Corporation; Freiburg im Breisgau; Vor Ort; EUR 80.000 - 100.000; Vollzeit

Zusammenfassung

A global diagnostics company in Freiburg is seeking a Product Care Manager to oversee post-launch products and ensure they meet high-quality standards. This role involves regulatory compliance, CAPA management, and cross-functional collaboration. Candidates should hold a Master’s degree in a relevant scientific field and have experience in the medical device industry. The position offers outstanding career prospects and a positive work culture.

Leistungen

Company pension scheme

Career development opportunities

Innovative work environment

Qualifikationen

• Master's degree preferred with additional qualifications for the IVD industry.
• Experience in assay or medical device development.
• Exceptional communication skills, fluency in English required.

Aufgaben

• Manage and optimize post-launch products in Autoimmunity division.
• Lead CAPA management and oversee product-related issues.
• Ensure compliance with regulatory guidelines including IVDR and ISO13485.

Kenntnisse

Leadership

Regulatory compliance

Problem-solving

Project management

Communication

Ausbildung

Master’s degree in biology, Immunology, or related field

Jobbeschreibung

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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, growing efficiency in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our distributed team of over 120,000 colleagues offers an outstanding mix of brand new technologies, convenient purchasing options, and pharmaceutical services across our top brands like Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

Location/Division Specific Information:

Phadia is the leading supplier of fully automatic blood analysis systems for allergy and auto-immune diseases. With our innovative products, we set standards worldwide and assist clinicians in providing fast and reliable diagnoses, thus helping patients at an early stage. Phadia GmbH in Freiburg is the German subsidiary of the Immunodiagnostics division of Thermo Fisher Scientific, a global company that develops, manufactures and distributes in vitro diagnostics in the field of allergy and autoimmune diagnostics. Our customers expect a consistently reliable and high standard of quality from our products, which we ensure through innovative biochemical and medical technology solutions as well as highly qualified and motivated employees.

A Day in the Life:

As the Product Care Manager (m/f/d) you will be responsible for the ongoing management and optimization of post-launch products within the Autoimmunity division, ensuring they continuously meet high-quality standards and adapt to evolving market and regulatory requirements. This role involves strategic leadership and close collaboration with cross-functional teams to handle product life cycles effectively, enhance product performance, and maintain compliance with industry standards.

Responsibilities:

• CAPA Management: Lead the strategic oversight and execution of Corrective and Preventive Actions (CAPA) to resolve product-related issues, ensuring timely and compliant closure of CAPAs.
• Regulatory Compliance: Ensure all product care activities adhere to regulatory guidelines, including IVDR and ISO13485, maintaining up-to-date product documentation and compliance records.
• Cross-Functional Collaboration: nurture strong relationships with R&D, Production Planning, Marketing, QA/RA, and other departments to effectively run CAPA and NC processes, ensuring seamless operational flow and adherence to regulatory standards.
• Continuous Improvement: Champion continuous improvement initiatives to enhance product quality and performance, applying root cause analysis to prevent recurrence of issues.
• Audit and Documentation Management: Prepare for and lead defense in internal and external audits; manage and be responsible for the creation and maintenance of all product care documentation to ensure full regulatory compliance.
• Team Leadership: Manage and develop a scientific team dedicated to product care activities, promoting professional growth and ensuring efficient and effective task completion.

Minimum Requirements/Qualifications:

• Master’s degree in biology, Immunology, or a related scientific field, preferably with additional qualifications or certifications relevant to the IVD industry.
• Profound experience in assay or medical device development, with a proven track record in managing product life cycles and compliance in a highly regulated environment.
• Strong leadership and problem-solving skills, excellent organizational abilities, and proficiency in managing complex projects and initiatives.
• Exceptional communication skills with fluency in English, both written and spoken, necessary for effective collaboration across diverse teams and collaborators. German is a plus.

What we offer:

• Employment with an innovative, future-oriented organisation
• Outstanding career and development prospects
• Company pension scheme and other fringe benefits
• Exciting company culture which stands for integrity, intensity, involvement and innovation

If you are interested, please apply online with your CV and Motivation Letter including possible start date and salary expectations.

At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or any other legally protected status.

Apply today! http://jobs.thermofisher.com

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