We have been retained by a startup medical device company in the structural heart space to recruit a seasoned Senior Quality Engineer. Ideal candidate has 5+ years in a Quality Engineer role in a medical device OEM with experience supporting Design, Development and Manufacturing.
This position will be accountable for all aspects of quality system processes including document control, quality record management, equipment calibration, preventative maintenance, materials management, receiving inspections, finished goods inspections, biocompatibility testing, sterilization validations etc. They will work closely with business operations and engineering to ensure quality and manufacturability for both new product development and commercial products.
Responsibilities also include establishing and fostering partnerships with suppliers and resolving supply chain concerns, non-conformances, CAPAs etc.
QUALIFICATIONS
• Bachelor’s degree in science/technology related field
• 5 + years’ experience in Quality in an FDA regulated industry
• 5+ years’ experience in Quality a Medical Device environment
• 5 + years’ experience in Medical Manufacturing environment, including experience in engineered new products and or PMA commercial products.
• Strong multi-tasking skills required
• Certified Quality Auditor (CQA) preferred
The company is based in the Minneapolis area and are ONLY considering local candidates as being onsite is required.