Quality Control Manager

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 Quality Control Manager is responsible for oversight of the quality control laboratory and supervision of direct reports. The Quality Control Manager has an in depth understanding of the various analytical testing and procedures. This position maintains internal policies and procedures in compliance with current FDA GMP regulations and applicable ISO standards. Anticipates the needs of the department and drives efficiency improvement projects to support operations. Promotes leadership throughout the department and mentors, manages and develops the talent and skills required for a successful outcome. 

•    Works with Customer Service and Operations to ensure product testing activities are prioritized and supported
•    Provides leadership and oversight for the daily lab operations
•    Works closely with R&D on test method development timelines and assay transfer
•    Provides direction to QC Scientist when troubleshooting assay failures
•    Reviews and approves LIR/OOT/OOS reports
•    Ensures lab equipment is maintained and calibrated  
•    Ensures lab area is maintained and all safety policies are followed and supported
•    Applies knowledge of Good Manufacturing Practice (cGMP) on a daily basis to supervise the lab area
•    Works closely with Quality Engineers and R&D Scientists to validate equipment, software and laboratory systems
 

•    Four-year technical degree with a minimum of 8 years’ experience in a regulated industry
•    Minimum 2 years of managing quality professionals
•    Proven supervision experience with strong leadership skills
•    Experience with Lean principles desired 
•    Experience with analytical instrumentation, method development and validation (QC)
•    Excellent analytical and problem solving skills
•    Excellent written and verbal communication skills
•    Excellent interpersonal skills

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.