Quality Systems Manager

Quality Management System Compliance Manager

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.