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, product approval and manufacturing scale up are smooth, timely and cost effective.
- 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.
- 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.
- Develops and executes required validations in line with regulatory standards to include equipment, process and product validations.
- Summarizes, analyses and in conjunction with the team draws conclusions and makes appropriate decisions from test results and other process related findings.
- Ensures appropriate process monitoring / controls are in place to maintain an effective validated process.
- Conducts root cause analysis and implements corrective action in a timely manner.
- Managing and investigating customer complaints including carrying out failure mode analysis and implementing required CAPAs relating to complaints where required
- Conducts audits, including closing out audit findings and creating and determining proper corrective and preventative action.
- Partner with suppliers to ensure their quality standards are in line with company standards.
- Maintenance of an effective quality management system in compliance with applicable regulatory requirements, including ISO13485.
- 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.
- Is creative, continually learning and exploring new ideas.
- A self-starter that applies their 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.
Or call Megan Warr on 085 8019023 for a confidential conversation