Job Description
Our client, a leading medical device company, is currently recruiting a Director of Quality who will infuse the Quality Team with their talent, energy and leadership skills. This is an exceptional opportunity to join a corporate culture that is known for its innovative and growth-oriented vision. Responsibilities include:
1) Serve as the QMS Management Representative, including QMS maintenance and performance reporting and promotion of customer requirements
2) Ensure maintenance and improvement of the QMS through routine system audits and corrective actions also ensure corrective actions, whether internal or external, are handled in a timely manner
3) Plan and direct the activities of quality engineering to ensure projects are being completed on a timely basis
4) Plan and direct the activities of inspection resources with the group supervisor to ensure consistent, reliable performance and timely response to internal and external needs
5) Manage the measuring and test equipment calibration program and coordinate activities of on-site and off-site calibration, as needed
6) Manage the corrective and preventive action system and function as the primary authority for all internal nonconformance resolution
7) Act as the primary resource and contact for external complaint resolution
8) Plan, promote and organize training activities related to product quality and reliability
9) Develop and maintain technical files to comply with the medical devices directive for submission to EU-notified bodies
10) Support Regulatory, Product Development and other job functions within the company
11) Manage quality functions and agreements with the company suppliers
12) Conduct or coordinate supplier audits, as required
13) Participate in customer visits and act as the company quality representative during complaint resolution at customer sites
14) Develop and analyze statistical data and product specifications to establish standards and propose methods to achieve customer requirements
15) Identify techniques and technologies to be used in process control and monitoring to improve quality, reduce inspection and increase product throughput with contract manufacturers
16) Participate as needed in product design reviews, new product quotes and quality planning to meet customer specifications
17) Act as the company quality representative during regulatory audits and is responsible for ensuring adequate and timely responses to findings as a result of those audits
Critical Requirements
1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the medical device industry is strongly preferred
4) Preference will be given to candidates with recent experience in quality management
For the right leader, this is a wonderfully rewarding role with tremendous growth prospects. If you are qualified and think you're a strong fit for this role, please apply ASAP. We thank all applicants, but only candidates who meet our client's criteria will be contacted.
Compensation and Other Details
Base Salary: Highly competitive package, commensurate with experience
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