Product Care Manager mfd - Research Development

Thermo Fisher Scientific; Freiburg im Breisgau; Vor Ort; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

A leading company in immunodiagnostics seeks a Product Care Manager to oversee post-launch products and ensure compliance with regulatory standards. The role involves leading a scientific team, managing CAPAs, and fostering collaboration across departments. Ideal candidates will have a Master's degree and significant experience in medical device development.

Leistungen

Outstanding career and development prospects

Company pension scheme

Exciting company culture emphasizing integrity and innovation

Qualifikationen

• Master's degree or equivalent experience in a relevant scientific field.
• Profound experience in assay or medical device development.
• Strong leadership and problem-solving skills.

Aufgaben

• Lead strategic oversight of CAPA to resolve product-related issues.
• Ensure compliance with regulatory guidelines including IVDR and ISO 13485.
• Foster collaboration with R&D, Production, and QA/RA.

Kenntnisse

Leadership

Problem Solving

Communication

Project Management

Ausbildung

Master's degree in Biology, Immunology, or related field

Jobbeschreibung

Location / Division Specific Information :

Phadia GmbH in Freiburg is the German branch of Thermo Fisher Scientific's Immunodiagnostics division. We develop and distribute allergy and autoimmune diagnostics.

How will you make an impact

Take on the role of Product Care Manager in Research & Development to ensure top-tier products. Your impact includes implementing outstanding care strategies and collaborating with diverse experts.

A Day in the Life :

Lead and cooperate across teams to manage post-launch products for Autoimmunity, ensuring quality and compliance.

Responsibilities :

• CAPA Management : Lead the strategic oversight 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 ISO 13485, maintaining up-to-date product documentation and compliance records.
• Cross-Functional Collaboration : Foster positive relationships with R&D, Production, Planning, Marketing, and QA/RA for smooth operational flow.
• 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 : Lead defense in audits internally and externally; manage creation and upkeep of product care documents for regulatory compliance.
• Team Leadership : Lead and develop a scientific team dedicated to product care activities, promoting professional growth and ensuring efficient task completion.

Minimum Requirements / Qualifications :

• Master's degree or equivalent experience 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.
• Outstanding communication skills with proficiency in English, both written and spoken; German is a plus.

What we offer :

• Employment with a forward-thinking organization
• Outstanding career and development prospects
• Company pension scheme and other fringe benefits
• Exciting company culture emphasizing integrity, intensity, involvement, and innovation

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

At Thermo Fisher Scientific, each of our 100,000 outstanding minds has an outstanding story to tell. Join us and contribute to our mission of 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!

Agency notice!

Please note we are not interested in receiving unsolicited CVs from any personnel service providers. Any such candidate documents sent or uploaded will not be acknowledged and will be deleted in line with our privacy policy.

Required Experience :

Manager

Key Skills

Instrument, Lighting, Gym, Event Production, Beauty Therapy

Employment Type : Full-Time

Experience : years

Vacancy : 1