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 is responsible for providing quality engineering support for all phases of the product lifecycle at Surmodics. This position will support the development and facilitation of quality engineering principles throughout the Whole Products Solution organization to achieve quality and regulatory compliance with the desired customer outcome.
Operations Quality Engineering (50%)
• 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
• Manage Calibration and Preventative Maintenance SystemsProduct Development (35%)
• Provide technical expertise in design controls and risk management
• Develop risk management plans and lead risk management activities
• Draft documents and provide technical review for document revision, review and approval
• Maintain design history file and lead design review discussions
• Support design transfer activities including IOQ review and approval for new equipment
Continuation Engineering (10%)
• Analyze engineering change requests
• 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
Purchasing & Supplier Controls (5%)
• Support supplier evaluations and material qualifications
• Lead supplier audits, draft final reports, and coordinate audit finding closure
• Provide technical assistance for first article inspections and ongoing performance monitoring
• Support the investigation and resolution of issues related to supplied components and services
• Four-year technical degree with minimum 8 years’ experience in a Quality Engineering role
• ASQ Quality Engineering certification desired
• Experience and training in process and equipment validation
• Extensive experience with QSR and ISO quality systems
• Extensive experience with statistical techniques, measurement/trending and SPC tools
• Strong attention to detail
• Proficient computer skills- Microsoft Word, Access and 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.