*** JOB LOCATION: VitalDyne Medical in Cokato, MN (subsidiary of CMD)
This position is accountable for the leadership of the quality department. He/she will work in conjunction with department leaders and the President, taking a leadership role in lead VitalDyne’s quality management system and continuous improvement initiatives.
Maintain a high level of reliability of product and services, ensure products conform to customer specification, promote teamwork throughout the quality organization, and perform management function such as hiring, termination, motivating and more to assure a high-performance team.
- Lead VitalDyne’s QMS (Quality Management System) to ensure process via SOP’s (Standard Operating Procedures), and procedures via WI’s (Work Instructions) support VitalDyne’s Quality Statement, meet regulatory/ISO requirements and support strong business ethical practices.
- As the Management Representative for Quality, representing VitalDyne for internal and external audits.
- Champion or lead quality assurance, nonconforming material review/reporting and/or continuous improvement initiatives in reduction of 100% final inspection and reduction of material scrap.
- Interface with Engineering and Operations to ensure development and transition of process and procedures from prototype to pre-production to full production.
- Promote strong GMP (Good Manufacturing Practices) and principles as well as DMP (Good Documentation Practices) and principles throughout the organization.
- Plan, schedule, and direct product quality control activities to ensure production is consistent with established standards/specifications.
- Evaluate, authorize and remove Suppliers as Approved Suppliers of materials used on Bill of Materials
Education and Experience Requirements:
Previous Quality Department experience, with previous Supervisor/Manager experience in Quality desired
Bachelor’s Degree in Engineering/Sciences or equivalent experience in medical device and quality control. Class II or III medical device experience preferred. Effective root cause analysis and GDP skills.
Minimum of 5 years of experience in manufacturing environment. Strong communication and use of statistical methods in reduction of 100% final inspection of products. Previous experience in contract manufacturing and complex catheter delivery systems strongly preferred.
Benefits: Medical, dental, retirement plan, disability, life insurance, paid holidays, and PTO