EDUCATION AND QUALIFICATIONS

• An Engineering or Quality Assurance Degree or equivalent experience.
• A minimum of 3 years post qualification experience as a Quality Assurance Engineer within a Medical Device or regulated environment.

Onsite Role, Days of Work: Monday to Thursday (4 Day Work Week)
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 devices 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 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 Assurance Engineer is a key member of the Quality team with responsibility for establishing, implementing and maintaining the Quality System on site.

Responsibilities

• Partner with R&D and Process Engineers to ensure that the transition of products through R&D and sister sites, product approval and manufacturing scale up are smooth, timely and cost effective.
• Promotes compliance and excellence within the company to customer requirements and the applicable regulatory standards.
• Participates in new product/technology development and supports the QA activities as part of an overall project team.
• Executes the project design plans, protocols and generates reports for new product development projects as well as design/process changes.
• Summarizes, analyses and in conjunction with the team draws conclusions and makes appropriate decisions from test results and other process related findings.
• Defines and implements Quality standards and specifications and helps to ensure that Regulatory requirements are met. Continually seeks to drive improvements in product and process quality.
• Develops and executes required validations in line with regulatory standards to include equipment, process and product validations.
• Conducts root cause analysis and implements corrective action in a timely manner.
• Conducts audits, including closing out audit findings and creating and determining proper corrective and preventative action.
• Creates and maintains company quality documentation.
• Deals with suppliers and ensures their quality standards are in line with company standards.
• Managing and investigating customer complaints including carrying out failure mode analysis and implementing required CAPAs relating to complaints where required.
• Provides manufacturing line support and provide Quality expertise in relation to Manufacturing issues and product disposition.