Director of Quality Assurance - Medical Device
Our client focuses on transformative solutions in the medical device industry. Currently, they are seeking Director of Quality Assurance.
In this role you will serve as a key member of the leadership team, leading both US and International manufacturing sites. We are seeking someone with 12+ years’ experience in a medical device with at least 7 years serving in a leadership capacity and focused on quality assurance. The ideal candidate will have proven experience developing and improving formal quality operational processes and procedures. Works closely with other functions of the company, including regulatory affairs, manufacturing, operations, facilities, purchasing, research & development, clinical affairs, medical affairs, sales & marketing, operations, and finance. This position will perform other activities as necessary to maintain customer satisfaction and ensure quality.
- Create and oversee the Quality Management Systems to meet FDA 21CFR820, ISO13485, and other regulatory requirements as applicable including CAPAs; Complaints; Validation; Audits, and Training
- Monitor, audit and lead effective coordination of investigations, root cause analyses, risk assessments, and implementation of change control, and corrective and preventive actions
- Lead a culture of continuous improvement throughout the company, developing a sense of urgency on key objectives
- Oversee QA associates Quality Staff:
- Bachelor’s or Master’s degree in science, health care, or related field or equivalent
- 12+ years of leadership experience in regulated medical device manufacturing
- Must have demonstrated experience and knowledge of MDD (EU-MDR), ISO, MDSAP, Quality Assurance & Quality Systems
- 7 + years of leadership experience in Quality Assurance within the Medical Device Industry
- Able to develop others and manage the performance of the team through coaching and feedback
- Strong verbal and written communication skills
- Able to foster excellent relationships and credibility quickly at all levels of the organization
- Collaborative with the ability to interact with all levels of the organization
- A confident individual who provides a good balance of risk-taking and sound judgment
Exemplar 360 is a talent and advisory partner focused on rapid-moving industries where business and technology converge. Our success as a company has been grounded in our ability to complete challenging assignments where time and precision are highly critical. With a range of recruiting, staffing and consulting services, Exemplar 360 operates with the speed and efficiency of a boutique firm.