Senior Supplier Quality Engineer

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 Supplier Quality Engineer will lead the coordination of onboarding and sustaining relationships with suppliers.  This individual will evaluate and communicate quality issues to suppliers and apply sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues. They will review and approve supplier corrective action plans and verification of effectiveness documentation. Through consistent communication they will maintain relationships with suppliers to ensure changes are addressed in either direction.  They will maintain supplier quality processes that are both complaint and efficient.

• Supports DA/QE core member of NPI project teams in supplier selection process
• Leads supplier evaluations and supports material qualifications
• Qualifies new suppliers based on project and business needs including supplier surveys, supplier evaluations, and supplier audits providing valuable insight to cross-functional team members on supplier maturity
• Complete supplier monitoring activities per established timelines, including execution of supplier surveys, supplier evaluations and supplier audits (including travel, as needed).
• Track and drive all supplier change notifications and assist with change impact assessments.
• Supports the investigation and resolution of issues related to supplied components and services
• Supports Design for Excellence (DfX) collaboration between R&D and Suppliers.
• Lead communication to suppliers on performance issues including Supplier Corrective Action Request (SCAR)

• Provide internal and external audit support
• Drive process collaboration across organization to ensure both visibility and consistency in processing
• Drive ownership and improvement opportunities for Supplier Quality processes to ensure compliance and efficiency
• Provide training opportunities to the organization to drive better understanding of Supplier Quality processes
• Create detailed trending and metric reports and present at quality review meetings

• Four-year technical degree with minimum 5 - 7 years’ experience in the medical device industry.
• ASQ Quality Auditor certification desired
• Experience with QSR and ISO quality systems
• Experience with statistical techniques, measurement/trending and SPC tools
• Strong attention to detail
• Proficient computer skills- Microsoft Word, PowerPoint, and Excel
• Excellent analytical and problem-solving skills
• Ability to read and follow 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.