Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Immunodiagnostics division, we are dedicated to advancing medical technology through innovative research and development. Our team is committed to designing and delivering cutting-edge instruments and software that improve patient care and streamline medical operations. We are seeking a highly skilled and motivated manager to lead software verification and validation team within the R&D organization.

We are now looking for an experienced Manager, Product Care and Compliance to lead our newly formed Product Care group. You will be instrumental in fostering a culture of excellence, guiding your team to achieve their full potential, and ensuring we have the right competences and skills in place.

This role is essential in ensuring the continuous improvement and compliance of our products through effective management of CAPA, complaints, change control boards, product compliance, and QMS processes.

Key Team Responsibilities:

Lead and coordinate CAPA (Corrective and Preventive Actions) and complaint processes, developing and owning related processes.
Coordinate and manage product care activities to guarantee timely and effective resolution of product issues.
Drive efficient and prioritized Change Control Board (CCB) processes.
Ensure continuous product compliance with relevant regulations and standards.
Manage and improve Quality Management System (QMS) processes within the department.
Collaborate with cross-functional teams to improve product care solutions proactively.
Develop and implement strategies to streamline workflows and improve focus within the team.

Challenges:

Prioritizing and envisioning efforts in product care tasks, including CAPA, complaints, and product compliance.
Driving more efficient CCB processes with clear priorities.

Qualifications:

Bachelor’s degree in engineering, Life Sciences, or a related field (Preference given to candidates with an Advanced degree).
At least 5 years of experience in product maintenance, quality oversight, or a relevant area within the medical device or diagnostics sector.
Established track record in supervising CAPA, grievances, and product adherence protocols.
Strong understanding of QMS and regulatory requirements.
Excellent leadership and team management skills.
Strong analytical and problem-solving abilities.
Effective communication and interpersonal skills.
High level of verbal and written skills in English.

What We Offer:

Competitive salary and benefits package.
Opportunity to work with cutting-edge technology in the healthcare industry.
A collaborative and innovative work environment.
Professional growth and development opportunities.

Join us in making a difference in the diagnosis and treatment of autoimmune and allergy diseases. Apply today!