We are looking for a Quality Assurance Engineer II to join us in our mission. This role is based in our facility in our Ballinasloe, Co. Galway and the working week is a 4 day compressed week from Monday to Thursday .
The Quality Assurance Engineer II is a key member of the Quality team with responsibility for 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 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.
- 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 requirements.
- 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.
What Surmodics offers:
We offer competitive rewards & compensation to meet the needs of our employees, and this includes:
- Competitive Salary Package
- Equity/Stock Options award
- Annual Bonus Plan
- Pension Plan
- Medical Insurance & Life assurance cover
- Employee Share Purchase Scheme
- Career advancement opportunities
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.