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Quality Assurance Engineer (Medical Device Sector)

Bern Canton
German & English
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Job Description
We are currently looking on behalf of one of our important clients for a Quality Assurance Engineer. The role is a permanent position based in Bern Canton & comes with good home office allowance.

Your Role:

• Ensure that the quality requirements for products, processes & documentation in the area of responsibility are met.
• Ensure that products are manufactured in accordance with current guidelines, specifications & standards such as cGMP, ISO 13485, CFR Part 820 & FDA Guidelines.
• Act as the main QA contact person.
• Check & approve manufacturing documents (e.g. work instructions, batch releases).
• Check & approve documents as part of qualification & validation activities (e.g. DQ, IQ, OQ, PQ).
• Review, approve & complete changes & associated documents in the area of responsibility (change control).
• Edit NC/CAPAs according to deviation management (e.g. classification, releases).
• Participate in internal, customer, authority & supplier audits.
• Work within multidisciplinary teams.

Your Skills & Profile:

• At least 3+ years of professional experience in the area of Quality Assurance / Quality Assurance Engineering / Quality Management.
• An in-depth knowledge in cGMP.
• Experience in a comparable role within the MedTech or Pharma sectors.
• Experienced in handling SAP & quality tools (e.B. FMEA, SPC, etc.).
• Skilled in risk-based decision-making.
• Any experienced in the field of Injection Molding &/or assembly is advantageous.

Your Profile:

• Completed relevant University Education.
• Ideally further trained in the field of Quality Assurance.
• Communicative, quality-conscious & both customer & solution-oriented.
• Fluent in English & a good command of German (to at least B1 Level) are mandatoy requirements.

If you wish to apply, please send us your resume in Word or PDF format.
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