Senior Quality Engineer

Ready to make a difference by utilizing your talents? Join a team driven by a mission to help patients, and a culture focused on developing medical device and diagnostic solutions.

Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease.

The Senior Quality Engineer will have the opportunity to be a key team member in supporting a medical device/combination product 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 final release of sterile medical devices/combination products.  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.

• Influence design controls and risk management development to ensure appropriate manufacturability/sustainability
• Drive Process FMEA, OQ, PQ with Process Development Engineer assistance
• Draft documents and provide technical review for document revision, review and approval
• Support design transfer activities including new equipment qualification
• Takes on ownership of Risk Management maintenance with Production Transfer

• Support of Supplier and Material Qualification Activities
• Provide technical assistance for first article inspections and ongoing performance monitoring
• Support the investigation and resolution of issues related to supplied components and services

• Analyze engineering change orders
• Support process and design change activities
• Support product stability programs by reviewing protocols and reports
• Analyze customer change notification requirements to support internal process changes
• Lead discussions with customers for addressing quality issues and change notifications

• Ensure products are being manufactured according to the defined requirements
• Initiate and contain nonconforming materials and perform evaluations of nonconforming material reports
• Lead and support operation improvement and efficiency initiatives
• Lead investigations to resolve quality issues
• Lead customer complaint evaluations and corrective actions
• Provide Quality support for Calibration and Preventative Maintenance Systems
• Provide Quality support for Infrastructure changes (e.g. facility, cleanroom, environmental monitoring)

• Develop and maintain key quality metrics
• Present trending data to management during management review
• Review current regulations and requirements and recommend changes to quality system
• Provide Quality Representation for NCMR, Complaints, internal and external audit findings and CAPAs

• Four-year technical degree with minimum 8 years’ experience in a Quality Engineering role
• ASQ Quality Engineering certification desired
• ASQ Software Quality Engineering certification required (if assigned)
• Experience and training in process and equipment validation
• Extensive experience with cGMPs, 21 CFR 820, ISO 13485, and applicable standards for Pharmaceutical, Medical Device, and/or Combination Products
• Extensive experience with statistical techniques, measurement/trending and SPC tools
• Strong attention to detail
• Proficient computer skills- Microsoft Word, Excel, statistic software (jmp, minitab)
• Excellent analytical and problem solving skills
• Ability to read and follow detailed instructions including generating detailed instructions
• Excellent written and verbal communication skills
• Excellent interpersonal skills
• Ability to prioritize activities relative to competing demands from multiple sources

Surmodics offers a competitive compensation and benefits package, including a bonus program, 401(k) with employer match, employee stock purchase plan and stock options.

Surmodics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.