\\n In this role, depending on operation priorities, you run projects as Process Validation, Software validation (CSV), Test Method or Change Control in collaboration with the Line Quality Specialist. You work in close collaboration with Quality & Operations departments, and you train your colleagues on quality work instructions.

Transversal Quality Specialist - Ballaigues, Switzerland

Key Responsibilities:

• Lead Process validation according to procedures in place and ensure Change Control is applied anytime significant change occurs on a process.
• Check that equipment used complies with its level of validation.
• Create/update Operational Documentation (Defect list, Control instructions\\xe2\\x80\\xa6) upon needs.
• Support Computer System Validation (CSV) according to procedures in place and ensure Change Control is applied anytime significant change occurs. Verify that software used on site complies with its level of validation.
• Develop Standard protocols for process validations in support to Line Quality Specialist.
• Ensure compliance in the implementation of Process Deviation (SI), according to procedures. Escalade to your manager if risk is identified and associated with a process deviation.
• Lead a cross functional team to perform Process risk analysis (pFMEA). Ensure all actions defined in pFMEA are implemented and verified. Perform impact assessment of product modifications and compare to quality level of its line. Ensure pFMEA are up to date and reviewed periodically.
• Work in close collaboration with Line Quality Specialist for semi-finished product manufacturing, and work as backup upon needs.
• Ensure compliance to all work instructions in place and perform Good Manufacturing Practice (GMP) and Line Clearance audits upon request.
• Review and assess Line Quality System vs Standards.
• Be an internal auditor (after relevant training).

Requirements and Qualification:
You hold at least a master\\xe2\\x80\\x99s degree in quality, Mechanical or Life sciences, or significant proven experience in the medical device industry. If you are an internal auditor or are Green Belt certified is a big advantage. You bring 2 to 5 years\\xe2\\x80\\x99 experience in a quality or manufacturing (mechanical processes) department as well as you have experience with manufacturing process including packaging, sterilization, cleanrooms ISO 7/8 (a plus).

QA tools like 6M, 8D, pFMEA have no secret for you and you love to work on projects as well.

You are fluent in French and English (verbal and written) and are a strong communicator.

What we offer:

• 25 days of holidays
• A leisure club organised by our employees
• On-site company restaurant with subsidised menus
• Free parking
• Dynamic, multicultural and stimulating working environment

3 Chemin du Verger
1338 Ballaigues\\n \\n \\n \\n \\n \\n

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