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Quality Assurance Expert

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

Your Role:

• Participate in, monitor & support development projects in production & other areas to ensure compliance with all relevant laws, regulations & specifications such as cGMP, ISO 13485, CFR Part 820 & FDA Guidelines.
• Support & implement daily Quality Assurance tasks; in particular relating to product releases, change management, quality documentation & processing deviation notifications.
• Review & release processes & documents arising in development & industrialization projects (e.g. design verification / qualification & validation documents).
• Participate in internal, customer, authority & supplier audits.
• Independently work within multidisciplinary teams.
• Carry put Sub-project management in assigned projects.

Your Skills & Profile:

• At least 5+ years of professional experience in the area of Quality Assurance.
• Skilled & experienced in Project Management.
• Proven expertise in the Validation & Qualification of Production Plants including Computer Software Validation.
• An in-depth knowledge in cGMP.
• Experienced in handling SAP & quality tools (e.B. FMEA, SPC, etc.).
• Skilled in risk-based decision-making.

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 very good command of German.

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