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
·
Provide
training and guidance to internal teams on design control, quality assurance
practices, and regulatory requirements
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.