Job Description

Medical Device Quality Management System Manager   

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 Management System (QMS) Manager role. This is an individual contributor role overseeing our medical device quality system, creating documentation, determining areas of improvement and leading change. This is a hands-on role working with the broader team. This position is 100% on site in Menomonee Falls.

Responsibilities:  

Managing the Quality Management System Software 

• Running Quarterly Quality Reviews with company leadership, preparing metrics, graphs, etc. 
• Managing the complaint process from receipt to closure, complaint metrics, etc. 
• Tracking inspection data and providing feedback to contract manufacturers and suppliers. 
• Managing CAPAs. 
• Create Product Specifications and other critical documents, and ensuring compliance. 

Supplier Management 

• Supplier audits.
• Managing SCARs. 
• Input to supplier agreements.

Interfacing with Research & Development

• Leading Design Transfer and New Product Introduction phase reviews
• Ensuring regulatory compliance for new products (label requirements, submissions, etc.)
• Assisting R&D on Design History File requirements 

Quality Improvement 

• Leading/guiding process validations 
• Executing design studies to improve product quality
• Generating supplier agreements 

Qualifications:  

• B.S. in engineering or similar. 
• 5 or more years experience with QMS for Medical Devices. 
• Mastery of medical device regulations.
• Strong interpersonal and leadership skills; you will be working with all employees. 
• Commitment to quality. 
• 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:   

• Supplier management. 
• Experience developing work training material, training others. 

Position is Full time.

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