Quality System Supervisor

vor 2 Monaten

Genf GE, Schweiz Skillhubs Vollzeit

Joining us is a chance to engage in impactful work that drives change and shapes the future of healthcare. We excel in thinking differently, viewing change as an opportunity to improve outcomes. With over 4,000 dedicated professionals, we constantly challenge the status quo to make significant strides in the healthcare industry.

**Key Responsibilities**

1. Quality Management Systems (QMS)
- Implementation & Maintenance: Develop and maintain the quality system, ensuring adherence to Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP).
- Continuous Improvement: Propose and implement actions to continuously enhance the quality system.
- Document Control: Ensure quality documents are controlled and distributed according to policies.
- Regulatory Conformance: Manage document changes to adhere to applicable procedures and regulations.

2. Audit Management
- Audit Execution: Implement internal and external audit plans, ensuring employee training and compliance with quality requirements and regulatory standards.
- Inspection Coordination: Organize and facilitate inspections and audits by health authorities and notified bodies.

3. Regulatory Compliance
- Documentation Management: Ensure timely and compliant delivery of documentation for international registrations.

4. Corrective and Preventive Actions (CAPA)
- CAPA Coordination: Manage the CAPA process in compliance with internal procedures and relevant standards.
- Follow-up and Review: Organize CAPA review boards and bi-weekly follow-up meetings.

5. Quality Planning
- Quality Plan Management: Ensure quality plans comply with internal procedures and standards.

Process Implementation: Oversee the implementation and tracking of quality plans.

6. KPI & Quality Reviews
- Performance Analysis: Manage KPIs and conduct quality reviews in compliance with procedures and standards.

7. Training Programs
- Training Oversight: Ensure effective training processes that provide personnel with necessary education, training, and competencies.
- Process Improvement: Continuously refine training processes to maintain competency levels across the site.

8. Team Management
- Resource Organization: Allocate resources to support quality system activities.
- Goal Setting: Establish and track objectives for quality system personnel in alignment with company goals.

**Qualifications**
- Educational Background: Master’s degree in Engineering, Life Sciences, Pharmaceuticals, or a related technical field.
- Minimum of 5 years in a quality assurance or compliance role with demonstrated team management experience.
- Experience as a PRRC or Management Representative delegate preferred.
- Bilingual Proficiency: Fluent in French and English.
- Proficient in managing audit processes, including external regulatory and notified body inspections (e.g., FDA).
- Technical Proficiency: Expertise with EtQ and Trackwise software.
- Communication Skills: Exceptional communication, organizational, negotiation, and interpersonal skills.
- Analytical Skills: Strong problem-solving capabilities.
- Industry Knowledge: Extensive understanding of medical device standards and regulations like ISO 13485, 93/42 EEC, EUMDR 2017/745, 21 CFR part 820, and various international regulations.

**Job Types**: 100%, Permanent

Work Location: In person

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