Quality Assurance Associate Manager (Hybrid)
Quality Assurance Associate Manager (Hybrid)
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
What you will do
In this role the Associate Manager will manage and maintain Strykers Quality Management System support internal and external audits and ensure our processes meet ISO 9001 and ISO 13485 standards. Will be responsible for coordinating quality assurance tasks including auditing and certification processes. This position has two direct reports.
Key responsibilities:
- Administer and implement the Quality Management System (CAPAs deviations change control risk analysis document control complaints) ensuring maintenance and compliance with ISO 9001 and ISO 13485.
- Coordinate and execute internal audits and participate in external audits following up on corrective actions and improvement opportunities.
- Develop and implement continuous improvement programs focused on efficiency and regulatory compliance.
- Manage and monitor warehouse processes from a quality perspective and in accordance with applicable regulations.
- Implement local regional or global processes as required by the quality system.
- Monitor local and regional key performance indicators (KPIs).
- Manage field action product retention and recall processes coordinating communication with suppliers and manufacturing sites.
- Supervise and collaborate on quality systemrelated training.
What you need
Required
- Bachelors degree in Engineering or a related field.
- 3 to 5 years of experience in quality assurance and quality management functions.
- Experience in the medical device industry and other regulated environments.
- Proven experience with Quality Management Systems based on ISO 9001 and ISO 13485.
- Experience as a lead auditor.
- Advanced English.
- Proficiency in Microsoft Office.
Preferred
- Experience with quality management tools and ERP systems (Trackwise or similar).
Required Experience:
Manager
Employment Type
Full-Time
