Operational Quality Engineer

Responsibilities

• Manage a team of two operational quality officers, overseeing prioritization and activity tracking for synthesis and filling processes
• Manage deviation processing by leading investigations to identify root causes and deciding on risk acceptance and batch disposition
• Monitor the performance of quality processes and ensure the compilation and review of batch records for product release
• Provide quality support to production and technical activities, including the approval of qualification and validation documentation
• Coordinate and record investigations related to customer complaints
• Participate in internal and external audits as well as regulatory inspections
• Provide technical and methodological support for non-conformity investigations and CAPA (Corrective and Preventive Actions)

Requirements

• Master's degree (Bac +5) in Engineering or Pharmacy
• At least 2 years of experience in the medical device, pharmaceutical, or cosmetic sectors
• Strong knowledge of regulatory requirements, specifically ISO 13485 and MDR 2017/745/UE
• Proven analytical, synthesis, and problem-solving skills
• Proficiency in technical writing and the ability to communicate assertively
• Strong sense of teamwork and responsibility

Benefits

• Attractive compensation package including a 13th-month bonus, profit sharing, and various savings schemes (PEE, PEERCO)
• Remote work policy (charte télétravail)
• On-site wellness activities, including sports classes
• Comprehensive support services including a nurse, social worker, and disability referent
• Family support benefits such as birth bonuses and childcare leave
• On-site catering options and daily hot beverages

About the Company

Vivacy is a leading player in the medical aesthetics and anti-aging field. Founded in 2007, this renowned French company specializes in the creation, production, and distribution of cutting-edge medical devices based on hyaluronic acid. Present in over 75 countries, Vivacy is committed to employee well-being, continuous learning, and environmental sustainability.