Specialist Quality Production Line

Dentsply Sirona Switzerland seeks a Specialist Quality Production Line in Ballaigues to oversee manufacturing quality, lead crisis management, and ensure regulatory compliance for medical devices.

The company is looking for a mid-level specialist to take full ownership of quality assurance on the production line. This role involves managing daily quality operations, handling emergency situations, and ensuring that all manufacturing processes adhere to strict standards and work instructions.

Responsibilities

• Oversee all quality aspects of the product line, including leading responses to quality emergencies and crisis situations.
• Verify that all manufacturing activities strictly follow established work instructions.
• Conduct regular GMP audits focusing on quality documentation, calibration records, and work instructions.
• Collaborate with Quality Specialists to manage quality holds within the area of responsibility.
• Lead root cause investigations for new defects or non-conformities identified during Material Review Board (MRB) meetings.
• Open non-conformity reports when significant quality issues recur.
• Review risk analyses and keep Process Failure Mode and Effects Analysis (PFMEA) documents current.
• Manage Corrective and Preventive Actions (CAPA) linked to operational quality problems.
• Develop quality dashboards in partnership with Operational Line Managers or line supervisors.
• Analyze Key Performance Indicators (KPIs) monthly to identify trends.
• Update defect lists as needed.
• Assess the Line Quality System against relevant standards and report any gaps to the Site Head.
• Lead process validation efforts and ensure Change Control procedures are applied for significant process changes.

Requirements

• Master’s degree in Medical Device Quality or Mechanical Engineering.
• 3 to 5 years of experience in a Quality Assurance department within the medical device, pharmaceutical, or automotive sectors.
• French language proficiency at a minimum C1 level.
• English language proficiency at a minimum B2 level.

Nice to have

• Experience as an internal auditor.
• Green Belt certification.

About the company

Dentsply Sirona stands as the world’s largest manufacturer of professional dental products and technologies. With over a century of innovation, the company has a long history of serving the dental industry and patients globally.

• The company is recognized as the global leader in professional dental products and technologies.
• It boasts over a century of innovation and service to the dental industry and patients worldwide.