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 Title: Quality Assurance Engineer
Reports to: Quality Assurance/Regulatory Affairs Manager.
The Quality Assurance Engineer is a key member of the Quality team charged with establishing, implementing and maintaining the Quality System on site.
- 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 those of Creagh Medical.
- Managing and investigating customer complaints including carrying out failure mode analysis and implementing required CAPAs relating to complaints where required.
- 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.
Competencies and Attributes
- Demonstrable detailed working knowledge of the medical device industry.
- An analytical approach to problem solving.
- Is creative, continually learning and exploring new ideas.
- A self starter that applies there own initiative in most situations.
- A good team player, who works well in a small team environment, must be able to work effectively with peers in other Departments.
- A good communicator who can easily convey his/her ideas and requirements across all levels in the organisation.
- Capacity to make sound judgements while learning from mistakes.
- Detailed knowledge of the regulatory environment in which the business operates including FDA, European, Canadian, Japanese and other International Regulatory requiremnts.
- Attention to detail while maintaining awareness of longer-term objectives.
- Strong interpersonal skills, a demonstrated ability to influence his/her peers and place quality at the forefront of everyone’s daily agenda.
- Displays the highest levels of integrity.
- Capacity to maintain the highest levels of confidentiality internally and externally.
- Ability to stay connected to multiple projects simultaneously.
Surmodics offers a competitive compensation and benefits package, including a bonus program, Defined Contribution Pension 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, colour, religion, sexual orientation, gender identity, national origin, disability, civil status or members of traveller communities.