Quality Manager

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 Quality Manager will have the opportunity to be a key leader 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, Design Assurance, 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.

ResponsibilitiesManagement

• Develops and maintains a solid team environment through effective hiring, communication, recognition, performance feedback and development
• Working manager that both manages the team and also serves a quality engineering function for assigned teams or projects
• Monitors, directs, and prioritizes staff workload to ensure business objectives are met
• Contributes to establishing department yearly goals and objectives
• Advises planning for department resource needs
• Foster a department culture of continuous improvement
• Responsible as primary interface for internal audits, regulatory body audits for responsible areas
• Determine appropriate staff levels and schedules while working with key partners to understand priorities and plan resource allocation accordingly

Product Development Support

• Influence Design Controls and Risk Management development to ensure appropriate manufacturability/ sustainability
• Assist in development of 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 (including Material Qualification and incoming inspection procedures)
• Take on ownership of Risk Management maintenance with Production Transfer

Operations Support

• Proved oversight of accurate and complete materials receiving and inspection activities
• 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

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

May be assigned other responsibilities of the company's quality system.

Minimum Qualifications

• BS or advanced degree in technical discipline
• 3+ years management experience
• 8+ years overall medical device experience
• 8+ years’ experience in Quality Assurance or Engineering function
• 5+ 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
• Strong ability to communicate (written and verbally) within and across disciplines and organizational structures
• Strong emotional intelligence to work effectively in a fast-paced, highly-collaborative environment
• 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

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.