Quality Engineer 2 presso Surmodics

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 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. 

Responsibilities  

• Lead projects related to Quality Management System (QMS) improvement. Strong project management skills preferrable. 
• Maintain and continuously improve QMS procedures and QMS software systems. 
• Interface with cross-functional departments to identify and resolve QMS process related issues. 
• Review current regulations and requirements and recommend updates to QMS. 
• Create and provide training for QMS and QMS changes across the organization. 
• Develop and maintain key quality metrics and present data at management review. 
• Support an effective internal audit program.  
• Prepare, participate and resolve issues identified from both internal and external audits. 
• Lead and/or provide Quality Representation for complex NCMR, Complaints, internal and external audit findings and CAPAs. 
• Author and track Quality Plans. 
• Help coordinate and lead any necessary field action/market withdraw  
• Assist in field return investigations  

Minimum Qualifications 

• 4-year technical degree with  
• minimum 8 years’ experience in a Quality Engineering or Quality Systems role 
• ASQ Quality Engineering or ASQ Auditor certification desired 
• Experience and training in process and equipment validation 
• Extensive experience with QSR and ISO quality systems 
• Strong attention to detail 
• Proficient computer skills- Microsoft Word, Access and Excel. 
• Excellent analytical and problem solving skills 
• Excellent written and verbal communication skills 
• Excellent interpersonal skills 
• Ability to prioritize activities relative to competing demands from multiple sources 

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.