Quality Assurance Manager
Vor 4 Tagen
**Quality Assurance Manager**
At Integra LifeSciences, we're committed to creating a better future for healthcare. As our Quality Assurance Manager, you'll play a critical role in ensuring our quality systems meet the highest standards.
Key Responsibilities:
- Implement and maintain quality systems for Codman Specialty Surgical (Integra LifeSciences Switzerland SARL)
- Propose and implement actions to improve Quality System
- Ensure GMP, GDP rules are known, understood, and respected in the site
- Ensure Quality system documents are controlled and distributed in compliance with applicable procedures
- Ensure that document changes are processed in conformity with applicable procedures and regulations
- Ensure that internal and external audit plans are followed, and employees are trained to QS requirements, quality policies, and relevant regulations
- Organize inspections and audits performed by health authorities and notified bodies
- Ensure that documentation required by affiliates or RA department in order to complete international registrations are provided in a compliant and timely manner
- Ensure that CAPA are managed in compliance with internal procedures as well as applicable standards and regulations
- Ensure CAPA follow-up, Organize and facilitate CAPA review Board, organize CAPA follow-up meeting every 2 weeks at a minimum
- Ensure QP are managed in compliance with internal procedures as well as applicable standards
- Ensure QP process is implemented and follow up
- Ensure KPI and Quality Reviews are handled in compliance with applicable procedures as well as applicable standards
- Ensure that training processes are in place and performant so that all assigned personnel have the education, training, and experience to carry out all job duties and responsibilities
- Provide input to continuously improve the training process to maintain the adequate level of competences of all employees at the site and ensure that all assigned personnel have the education, training, and experience to carry out all job duties and responsibilities
- Organize necessary resources to support QS activities
- Ensure that goals and objectives are set and followed for every QS employee in accordance with companies G&O's
Requirements:
- Minimum of a master's degree is required, preferable in Engineering, Life Science, pharmaceutical, or any related technical discipline or equivalent
- Minimum 5 years of professional work experience within a quality assurance or compliance environment
- Prior experience as PRRC, Management Rep. delegate
- Demonstrated experience in team Management with strong management skills and leadership
- Fluent in French and English
- Qualification and experience in Audit processes
- Prior experience of External Regulatory and/or Notified Body Inspections (e.g. FDA)
- Strong communication, organizational, negotiation, and interpersonal skills
- Strong analytical problem-solving skills
- Experience in EtQ and Trackwise software
- The ability to collaborate with all levels of management across multiple sites and functions
- Strong knowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC, EUMDR 2017/47, 21 CFR part 820, Canadian, Japanese, Australian, Brazilian Regulation
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