Overview :
As a Senior Quality Manager, you'll play a pivotal role in ensuring the highest standards of quality and compliance. You will lead a team of professionals, fostering a culture of excellence and driving continuous improvement.
Your expertise will be instrumental in maintaining a robust Quality Management System (QMS) that meets regulatory requirements and exceeds customer expectations.
Job Responsibilities :
- Manage and lead a team of Quality Engineers and Associates, providing guidance and mentorship in quality and medical device best practices.
- Develop, maintain, and execute quality procedures to inspect and report quality issues, ensuring products meet specifications.
- Oversee the maintenance and effectiveness of the ISO quality system, driving continuous improvement and compliance.
- Lead internal and external audits, including CAPA, NCR, and customer complaints, ensuring thorough investigation, root cause analysis, and documentation.
- Ensure document control, revision control, and process validation activities comply with regulatory requirements.
- Collaborate with purchasing and co-manage the approved supplier list, evaluating suppliers for product compliance.
- Foster a "culture of quality" by providing resources, support, and recommendations for growth.
- Communicate effectively with management and stakeholders, upholding corporate values of safety, quality, ethics, and innovation.
Requirements :
- Bachelor's degree in quality, risk management, mechanical or industrial engineering, or equivalent experience.
- 8+ years of professional experience in quality management for medical device manufacturing, with progressive scope and responsibility.
- Proven leadership and team management skills, with experience leading a diverse QA and QC team.
- Certifications such as CQA, CQE, Lead Auditor, or Internal Auditor preferred.
- Extensive knowledge of ISO 13485, 21 CFR 820, MDSAP, PPAP, Control Plans, PFMEA, GRR, and MSA.
- Strong customer management, conflict resolution, project management, and decision-making abilities.
- Excellent communication skills, both written and verbal, with a talent for presentations.
- Experience in disposable products / cleanroom manufacturing is preferable.
- Familiarity with REACH, RoHS, and Conflict Material Surveys is required.
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