Quality Engineer 2

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 Engineer 2 is a key team member in supporting medical device manufacturing through commercial distribution.  They will maintain oversight of all manufacturing activities and be responsible for the final release of sterile medical devices.  Key partnerships with Operations, Marketing, Complaints, Supply Chain, Engineering, and other functional experts will be developed as needed to ensure a consistent flow of product to meet customers’ needs and to address actions for field inventory as necessary.   They will look to continuously improve internal processes to drive efficiency in the day-to-day activities.  

Responsibilities  

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  
• Review sterilization results for sterile product and addressing any non-conformances, release sterile product 
• 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   
• Initiate/support quality system changes that drive consistency and efficiency   
• Generate and evaluate metrics that are used to identify negative trends and areas for improvement  

Maintain oversight of commercial product to ensure safety and traceability  

• Manage any returned product through inspection and disposition  
• Assist in field return investigation and the coordination of any necessary field action/market withdraw   

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

Minimum Qualifications 

• 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  
• 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 determines base pay by evaluating market data, internal equity, skills, abilities and level of experiences for each unique, potential employee.  

Surmodics offers a competitive compensation and benefits package, including a bonus program, 401(k) with employer match, tuition reimbursement and student debt repayment program.

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.