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Quality Assurance Lead
3 months ago
Adecco is looking for a dedicated and detail-oriented professional to fill the role of Quality Manager. This position is ideal for individuals who are committed to enhancing and upholding quality management systems.
As the Quality Manager, your primary responsibility will be to oversee and coordinate the Quality Systems at the designated site. You will ensure adherence to all applicable quality and regulatory requirements, playing a crucial role in supporting the organization’s responsibilities as a legal manufacturer of medical devices.
Key Responsibilities:
- Overseeing Quality Investigation Reports and deviations, and formulating and executing CAPA plans.
- Conducting routine evaluations of quality-critical documents, systems, and procedures to identify and implement necessary improvements.
- Managing and maintaining all essential quality documents, including Quality manuals, SOPs, Quality Policies, and Audit Reports.
- Leading initiatives for process enhancement across the manufacturing facility.
- Serving as the leader of the internal audit team.
- Collaborating with Production, Warehouse, and Maintenance teams to uphold quality standards and address any challenges.
- Assisting production in high-stakes routine validation activities, including sterile manufacturing, C2C validation, and media fill.
- Reviewing and endorsing audits related to housekeeping, fabrication, and glass.
- Leading and facilitating external audits conducted by clients and regulatory bodies.
- Monitoring on-site temperature and ensuring that equipment, processes, and new products are properly validated and verified.
Qualifications for Success:
- At least 3 years of experience in Quality Management within a regulated healthcare setting.
- Thorough understanding of regulations governing healthcare product development, including GMP, GDP, Medical Device, ISO 9001, and ISO 13485.
- Strong problem-solving abilities and a collaborative mindset.
- Willingness to share expertise and insights with colleagues.
Preferred Qualifications:
- Experience in a cleanroom environment.
- Prior experience in team management.
Adecco values integrity, continuous improvement, teamwork, and a unified approach. If you seek a company that embodies these principles and provides excellent opportunities for personal and professional development, this role may be the right fit for you.
