ORGENTEC Diagnostika GmbH is
the global market leader in the development and production of test systems for
the diagnosis of infectious and autoimmune diseases. As part of the Sebia
Group, headquartered in Lisses/France, ORGENTEC
supplies medical laboratories in over 100 countries with highly specialised and innovative devices and test kits. Our
company is characterised by steady and sustainable
growth in an internationally oriented, future-oriented business field.
To strengthen our team at the Mainz site, we are
looking for a
Quality
Design Manager
(m/w/d)
Main Tasks:
·
Oversee the implementation and management of the design control process
for medical devices, ensuring compliance with FDA (21 CFR 820) and ISO 13485
standards.
·
Collaborate with respective Departments to ensure product design changes
and modifications are developed with quality and regulatory compliance in mind.
·
Contribute to risk management activities for new products and design
changes using tools such as FMEA (Failure Modes and Effects Analysis), risk
assessments, and fault tree analysis in alignment with Product Risk Manager
·
Oversee design validation and verification testing to ensure product
performance meets safety and regulatory standards.
·
Work with cross-functional teams to ensure quality concerns are addressed
early in the design process and product risks are mitigated.
·
Providing guidance on quality standards throughout the product
development cycle.
·
Manage and support internal and external audits related to design
controls and quality assurance activities, ensuring the company is prepared for
regulatory
Skills:
·
Bachelor's degree in Engineering, Quality, Life Sciences, or a related field. A Master’s
degree is a plus.
·
Minimum
of 3 years of experience in design quality or quality assurance in the medical
device industry.
·
At least
2 years of experience in a managerial or leadership role, managing a team of
quality professionals.
Benefits :
·
Permanent employment contract
·
A
crisis-proof job with an attractive income
·
Annual
salary review
·
Flexible
working hours
·
Individualised
employee development and training
·
Attractive
package of health and social benefits (e.g. subsidised
computer glasses, flu vaccination, employer contribution of 30% to private
pension scheme)
·
Employer
subsidy for the canteen, free drinks
·
Crèche
and kindergarten allowance (max. €200)
·
Employee
discounts with well-known brands
·
Anniversary
bonus
·
Car
park directly at the company
We look forward to receiving your application (cover
letter, CV, references) by e-mail to jobs@orgentec.com. Please state your
salary expectations and a possible starting date.