Quality Associate 2

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. Job Summary The Quality Associate 2 is responsible for quality assurance activities to support operations and product release, as well as contributing to the maintenance and improvement of the overall quality system to ensure compliance with Quality System Regulations (QSR), ISO and other applicable requirements. Responsibilities Quality Assurance Support (20 - 50%)

• Lead/participate in CAPAs/Nonconformances
• Support Supplier Quality activities
• Assist Quality Engineering in assigned tasks to support product and manufacturing operations
• Support release of intermediates and final product for internal and external distribution
• Assist in completion of customer-requested documentation (i.e. customer quality system surveys)
• Participate in improvement and efficiency projects within Quality and cross-functionally
• Oversee material/product retain management program Quality Systems Support (50 - 80%)
• Ensure quality procedures, processes and systems are standardized throughout the business and implemented consistently and correctly to ensure compliance to internal requirements and external regulations
• Write and revise documents to ensure compliance to internal requirements and external regulations
• Support internal audits of quality system processes, manufacturing areas and documentation, as assigned
• Support Quality leadership in managing external audits (customer and Regulatory)
• Develop and present training material for new or changing processes, as required, to ensure compliance to procedures/regulations
• Serve as Quality Event (Nonconformances, CAPA, Complaint) Coordinator to assist in the completion and review of investigations/records for content, accuracy and completeness
• Assist in developing and maintaining quality system metrics
• Provide insight for statistical trends using quality system data and the creation of system solutions for quality system issues
• Ensure all quality system documentation and record keeping activities are carried out and completed in compliance with established procedures and work instructions
• Perform Document Administration activities within the eQMS software
• Coordinate and archive quality records
• Participate in improvement and efficiency projects within Quality and cross-functionally

• Four-year technical degree with minimum two years of experience in medical device industry or minimum ten years of experience in Quality-related field in medical device industry
• Proficient computer skills- Microsoft Word, Access and Excel
• Excellent problem solving skills
• Ability to read and follow detailed instructions
• Ability to generate detailed instructions
• 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, tuition reimbursement and student debt repayment program.

Quality Assurance Support (20 - 50%) • Lead/participate in CAPAs/Nonconformances • Support Supplier Quality activities • Assist Quality Engineering in assigned tasks to support product and manufacturing operations • Support release of intermediates and final product for internal and external distribution • Assist in completion of customer-requested documentation (i.e. customer quality system surveys) • Participate in improvement and efficiency projects within Quality and cross-functionally • Oversee material/product retain management program Quality Systems Support (50 - 80%) • Ensure quality procedures, processes and systems are standardized throughout the business and implemented consistently and correctly to ensure compliance to internal requirements and external regulations • Write and revise documents to ensure compliance to internal requirements and external regulations • Support internal audits of quality system processes, manufacturing areas and documentation, as assigned • Support Quality leadership in managing external audits (customer and Regulatory) • Develop and present training material for new or changing processes, as required, to ensure compliance to procedures/regulations • Serve as Quality Event (Nonconformances, CAPA, Complaint) Coordinator to assist in the completion and review of investigations/records for content, accuracy and completeness • Assist in developing and maintaining quality system metrics • Provide insight for statistical trends using quality system data and the creation of system solutions for quality system issues • Ensure all quality system documentation and record keeping activities are carried out and completed in compliance with established procedures and work instructions • Perform Document Administration activities within the eQMS software • Coordinate and archive quality records • Participate in improvement and efficiency projects within Quality and cross-functionally