Job Description

Global External Manufacturing is the competence center for single-use injection molded parts in the diagnostic workflow. This includes the development of new consumables, product care activities, the assurance of supply as well as the supplier selection and maintenance in close collaboration with Procurement.
As a Product Quality Assessor, you are responsible for the evaluation of the test results to ensure the products meet the required test specifications. Furthermore, this role is responsible for processing deviations and field complaints, including root cause analysis, risk classification, and definition of appropriate mitigations.
Location: Rotkreuz
Contract duration: 12 months/will be extended
Workload: 100%
Responsibilities:

• Responsible for processing the inspection lots
• Responsible for Improvement & Resolution Management according to effective processes including non-conformities, CAPA, SCAR, WVP, etc.
• Responsible for the compliant coordination and execution of the deviation and complaint process and the corresponding KPIs
• Determine the inspection sample size and test criteria
• Responsible for communication with suppliers regarding quality assessments
• Act as point of contact to the inspection center
• Evaluate test results
• Responsible for management of test equipment

Requirements:

• Excellent communication skills in German and English
• B.Sc. or M.Sc. degree in Engineering, Natural Science or related disciplines or apprenticeship with high degree of subject matter expertise
• 1-3 years years of work experience in External Manufacturing Business
• Experience in IVD/MD product manufacturing and testing, preferably in injection molding Technology
• Track record of experience with deviation and complaint handling in the highly regulated environment
• Sound knowledge in In-vitro diagnostic related regulations, such as ISO 13485, IVDR/MDR, FDA 21 CFR part 820 etc.
• Knowledge of Process Management and statistical methodologies (Lean, Six Sigma, etc.) - Green Belt certification preferred

Sounds like a great job?
Then we look forward to receiving your complete application documents through our online application form.
When applying by email, the sender agrees that his or her data will be used in accordance with our data privacy policy.
Find more vacancies at:
Job profile

• Zug
• Contracting
• Full Time
• As soon as possible/latest start date - December 2025 - 12 month duration/will be extended

Sounds interesting?
Simply click "Apply now" and I will get back to you.
Agnieszka Kawalec
Talent Acquisition Consultant
Similar jobs
blog
31. Jul. 2025
Got your red and white flags ready for the 1st of August? On Switzerland's 734th National Holiday (and 177th year with a ...
23. Jul. 2025
We welcome Mathias Kolbinger to the Coopers family.
16. Jul. 2025
Coopers bei bike to work 2025: Wir sind wieder geradelt. Alle Zahlen, Highlights und unsere Top-Velofahrer:innen im Blog.
09. Jul. 2025
New roles are emerging. Reskilling is the key to preparing people and companies for the future. Why now is the time to rethink and how Coopers recognizes potential before it is visible on CVs.