• Manage QMS compliance with the appropriate internal and external regulatory requirements (including but not limited to FDA, ISO, MDD/MDR, and individual country requirements).

• Manage Document Control system, including the Change Order process.

• Manage the CAPA, Complaints, SCAR, and Audit Findings processes.

• Lead supplier management, including maintaining the Approved Supplier List for Critical/Crucial Suppliers and facilitating the re-evaluation of suppliers, including review of supplier data as appropriate.

• Own the development of Quality Metrics, and coordinate quality data collection and analyses for use in Management Reviews.

• Lead for regulatory body audits.

• Manage the Internal and Supplier Audit processes.

• Lead Management Review and Quality Planning.

• Lead and manage site training program.

• Track and report on company Quality KPIs.

• Organize and lead monthly company meetings on established KPIs and Trends.

• Coach, counsel, and train direct reports.  Monitor performance and take appropriate action as necessary.

• Identify and implement improvement opportunities to increase the efficiency and effectiveness of the QMS.

• Other projects and tasks as assigned.

EXPERIENCE/SKILL REQUIREMENTS:   

Minimum of 7 years of experience in a Medical Device environment, 3-5 years supervisory experience.  A working knowledge in the following areas:

• Internal and External auditing

• Corrective and Preventive action

• Excellent verbal, written and presentation skills

• Detailed organization skills

• Team player with excellent communication skills

• ISO 13485 and FDA Quality System Regulation 

• Strong knowledge of Quality Systems programs including but not limited to Document Control, Record Control, Change Control, Training, and Device Master Record (DMR)

• Demonstrated experience in administration of electronic systems such as PLM, ERP, and MDM systems

• Strong communication skills, both written and oral; Ability to lead meetings and presentations

• Must be able to effectively communicate up/down and across different levels of the organization

• Demonstrated ability to work with MS Word, Teams, Excel, Project and Visio

• Demonstrated ability to independently troubleshoot issues with electronic systems

• Demonstrated experience in training users on systems and processes within an electronic environment

• Certified Internal Auditor preferred

• Lean and Six Sigma Green Belt Certified preferred

EDUCATIONAL REQUIREMENTS:  

Bachelor’s with at least 7 years of experience. Or Master’s Degree with 6 years. 15+ years of experience may be considered in lieu of a degree for a candidate who can demonstrate the combination of experience, training, and education to be capable of successfully fulfilling all duties and responsibilities of the position.