Changing lives. Building Careers.

Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.

Responsibilities:

QMS:

Implement and maintain quality system for Codman Specialty Surgical (Integra Life Sciences Switzerland SARL). Continuously propose and implement actions to improve Quality System. Ensure GMP, GDP rules are known, understood and respected in the site.Ensure that 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

AUDIT

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.

REGULATORY COMPLIANCE

Ensure that documentation required by affiliates or RA department in order to complete international registrations are provided in a compliant and timely manner.

CAPA

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

QUALITY PLAN:

Ensure QP are managed in compliance with internal procedures as well as applicable standardsEnsure QP process is implemented and follow up

KPI, Quality Reviews 

Ensure KPI and Quality Reviews are handled in compliance with applicable procedures as well as applicable standards

TRAINING:

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 responsibilitiesProvide input to continuously improve the training process to maintain the adequate level of competences of all employees ate the site

MANAGEMENT:

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.

Qualification :

Minimum of a master’s degree is required, preferable in Engineering, Life Science, pharmaceutical or any related technical discipline or equivalentMinimum 5 years of professional work experience within a quality assurance or compliance environmentPrior experience as PRRC, Management Rep. delegateDemonstrated experience in team Management with strong management skills and leadershipFluent in French and EnglishQualification and experience in Audit processesPrior experience of External Regulatory and/or Notified Body Inspections (e.g. FDA)Strong communication, organizational, negotiation and interpersonal skillsStrong analytical problem-solving skills. Experience in EtQ and Trackwise softwareThe ability to collaborate with all levels of management across multiple sites and functionsStrong knowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC, EUMDR 2017/745, 21 CFR part 820, Canadian, Japanese, Australian, Brazilian Regulation