What are the responsibilities and job description for the Medical Device Quality Engineer position at Vector Surgical?
Medical Device Quality Engineer
Vector Surgical is an award-winning medical device company. Small, yet dynamic, we are growing quickly and looking for an outstanding individual for our Quality Engineer position. This role will be responsible for managing our Quality Management software, leading the company’s Quality Management System and executing many quality/regulatory projects. This will be a hands-on role working with and improving these processes and leading change. This position is 100% on site at the production facility in Menomonee Falls.
Responsibilities:
- Improve product quality and regulatory compliance
- Managing the Quality Management System Software
- Running Quarterly Quality Reviews with company leadership
- Managing the complaint process from receipt to closure
- Creating/modifying product specifications
- Creating training plans and managing training
- Managing incoming inspection and feedback to contract manufacturers and suppliers
- Working with R&D on Design History Files
- Leading/Guiding Process validations
- Executing design studies to improve product quality
- Leading Supplier audits, documentation, Product/Part specifications
- Leading Design Transfer and New Product Introduction
- Generating/managing supplier agreements
- Managing CAPAs and SCARs
Qualifications:
- B.S. in Engineering
- Experience with QMS in cGMP environment
- General understanding of medical device regulations
- Strong interpersonal and leadership skills. You will be working with all levels of the organization
- Commitment to quality: Improve product quality and regulatory compliance
- Positive, energetic style that supports the success of entire team
- Must be hands-on, and willing to perform a variety of roles and functions
Preferred Skills:
- Medical Device experience
- Regulatory experience such as labeling medical devices
- Experience developing work training material and training teams