Quality Assurance Director

Vor 4 Tagen

Basel, Schweiz LHH Vollzeit

Our client is a Medical Device Company

Your next Responsibilities:

- To be the Quality Management representative for the site as well as the Person Responsible for Regulatory Compliance
- Establishes and maintains quality assurance programs, procedures and controls including quality control, quality engineering, product release, CAPA and non-conformances, document control, complaint investigation,
- Ensures that performance and quality of products conforms to established company and regulatory standards
- Develops and implements the company quality assurance strategies
- Acts as advisor to subordinate supervisors or staff to help meet established schedules or resolve technical or operational problems
- Submits and administer budget schedules and performance standards
- Oversees quality assurance auditing of production areas and systems
- Reviews reports findings and makes recommendations for corrective actions
- Provides support to the Supplier Quality assurance team
- Collaborates with Plant Manager and site Leadership team to maximize product reliability and minimize cost
- Organizes the department to support QA activities. Ensures that goals and objectives are set and followed for every QA employee in accordance with companies Governance & Oversight’s.
- Participate and ensure that investigations and other actions are done in due time to support operations plan
- Ensure Lean management activities in QA department
- Ensure that all assigned personnel have the education, training and experience in order to carry out all job duties and responsibilities
- Ensures the implementation of world-class quality programs to support entire product life cycle with focus on business results including prevention and detection of defects at earliest phase
- Escalate any product /resources issues to site and QA management
- Reporting as per group guidelines (Tier 3,)
- Take in charge project as requested by management
- Propose and if approved put in place any improvement for the organization

Who you are:

- Master Degree in Engineering, Life Science or a related technical discipline.
- At least 10 years of professional work experience within a quality assurance or compliance audit environment
- Demonstrated experience and track record in people leadership and in conducting and/or leading regulatory assessments in an international, global context, in a regulated environment
- Prior experience of External Regulatory and/or Notified Body Inspections (e.g. FDA)
- Strong management skills
- Strong communication, organizational, negotiation and interpersonal skills
- Strong analytical problem-solving skills.
- The ability to collaborate with all levels of management across multiple sites and functions
- Fluent in French and English
- Strong knowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC,2017 745, 21 CFR part 820, EUMDR, Canadian, Japanese, Australian, Brazilian regulation
- Result driven, Proactive

BOOST Permanent position

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