Quality Assurance Engineer
What you need to know
Do you want to work for a leading innovative Medical Device Company in the West? Continue to read if so…
This company 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.
The Quality Assurance Engineer is a key member of the Quality team charged with establishing, implementing, and maintaining the Quality System on site.
This is a Permanent role
Location: Ballinasloe, Galway County, Ireland
Your new job
Key duties & responsibilities include:
- 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.
What are we looking for?
- 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.
- Demonstrable detailed working knowledge of the medical device industry.
- An analytical approach to problem solving.
- A good team player, who works well in a small team environment, must be able to work effectively with peers in other Departments.
- Detailed knowledge of the regulatory environment in which the business operates including FDA, European, Canadian, Japanese and other International Regulatory requirements.
- Strong interpersonal skills, a demonstrated ability to influence his/her peers and place quality at the forefront of everyone’s daily agenda.
- Ability to stay connected to multiple projects simultaneously.
Benefits: Competitive compensation and benefits package, including a bonus program, Defined Contribution Pension with employer match, employee stock purchase plan and stock options.
Apply for this job now or get in touch with Aoife at email@example.com