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Senior Quality Professional
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The Senior Quality Manager plays a pivotal role in driving a culture of compliance, responsiveness, and data-driven decision making. This individual will ensure the quality team is structured appropriately and provide direction to individuals reporting to them.
Key Responsibilities:
- Establish, implement, and maintain processes and documentation needed for the Quality Management System (QMS) per standards/regulations ISO 13485 and FDA 21 CFR 820 for medical business, IATF 16949 for automotive business, and ISO 9001 for technology business.
- Manage, plan, and perform internal and external quality audits to ensure compliance to the standards, regulations, and documented quality management system.
- Report to executive management on the performance of QMS regularly.
The ideal candidate will possess:
- A Bachelor's Degree in Science or Engineering.
- Minimum 10 years of progressive responsibilities in quality assurance and control in manufacturing or equivalent.
- Robust knowledge and understanding of ISO 13485, FDA 21 CFR Part 820, and/or Medical Device Directives for medical business and ISO 16949 for automotive business.
- Strong knowledge of GMP requirements in a regulated manufacturing environment.
This role offers opportunities for professional growth and development, including:
- Continuous improvements in quality areas and participation in related cross-functional projects.
- Driving and implementing value-add quality initiatives and focusing on performance/metrics data for preventative and corrective action measures.
The Senior Quality Manager will also be responsible for:
- Ensuring quality records are complete and accurate as well as quality control operations are effective and efficient.
- Serving as the quality point of contact for customer audits, complaints, and product quality issues.
