Our mid-sized medical device client is adding a Senior Quality Engineer to the team! The Sr. QE will have the opportunity to be a key team member in supporting a medical device from transfer to manufacturing through commercial distribution. They are responsible for ensuring a smooth transition of new products to the manufacturing floor with the assistance of a cross-functional team. They will maintain oversight of all manufacturing activities and be responsible for the final release of sterile medical devices. Develop key partnerships with Operations, Marketing, Complaints, Supply Chain, Engineering, and other functional experts as needed to ensure a consistent flow of product to meet customers’ needs and addressing actions for field inventory. They will look to continuously improve internal processes to drive efficiency in the day-to-day activities.

Your role with the company:

Product Development Support: As new product roles from design to production the Sr QE partners with the Design Assurance Engineer to understand the product design and ensures product success in manufacturing by:

• Influence Design Controls and Risk Management development to ensure appropriate manufacturability/ sustainability
• In-Process Inspection Test Method Validation protocols, testing, reporting
• Drive PFMEA, OQ, PQ with Process Development Engineer assistance
• Development of in-process inspections
• Support of Supplier and Material Qualification Activities (incl. FAIRs and incoming inspection procedures) with Supplier Quality as owner
• Takes on ownership of Risk Management maintenance with Production Transfer.

Operations Support: Commercial production requires consistent support to ensure product is safe and effective for patients.  The Sr. Quality Engineer supports operations by:

• Support materials receiving and inspection activities with Supplier Quality as owner.
• Ensure quality of produced products by understanding production process and performing/reviewing in-process and finished goods inspections.
• Release of sterile product by reviewing sterilization results and addressing any non-conformances.
• Draft and route a variety of protocols and reports for product, processes, manufacturing events, and equipment changes/activities.
• Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).
• Support controlled facilities environment by participating in environmental monitoring, calibration, and preventive maintenance activities.
• Perform equipment qualification for any new and changing equipment requirements
• Drive/support quality system changes that drive consistency and efficiency
• Generate and evaluate metrics that are used to identify negative trends and areas for improvement

Field Support: Maintain oversight of commercial product to ensure safety and traceability:

• Manage any returned product through inspection and disposition
• Help coordinate and lead any necessary field action/market withdraw
• Assist in field return investigations

Desired Profile:

• BS or advanced degree in technical discipline
• 5+ years overall medical device experience
• 5+ years’ experience in quality assurance or engineering function
• 3+ years support of a medical device in a quality engineering function
• Understanding of Quality Systems requirements as outlined in CFR820/ ISO13485, and be able to communicate true requirements to cross-functional teams.
• Knowledge of medical device design control waterfall
• Experience with utilizing a risk-based approach to quality systems processes
• Demonstrated technical expertise and leadership in quality
• Self-starter, with the ability to manage multiple tasks and tight timelines
• Demonstrated use of Quality tools and methodologies
• High attention to detail, organization, and accuracy
• Strong emotional intelligence to work effectively in a fast-paced, highly-collaborative environment