Kelly Services are recruiting for a Quality Assurance Engineer for a County Galway based medical device company.
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.
Kelly Services are acting as an Employment Agency in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement. For information regarding data protection at Kelly, please visit the Kelly website and have a look into the Privacy Statement.
As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.