Title: Quality Assurance Engineer
The Quality Assurance Engineer is a key member of the Quality team with responsibility for establishing, implementing, and maintaining the Quality System on site.
- Collaborate with R&D and Process Engineers to make sure that the transition of products through R&D, product approval and manufacturing scale up are smooth and timely.
- Define and implement Quality standards and specifications and help make sure Regulatory requirements are met. Constantly seeks new improvements in product and process quality.
- Partake in new product/technology development and supports the QA activities as part of overall projects.
- Carry out project design plans, protocols, and generate reports for new product development projects, and design/process.
- Develops and executes required validations which comply with regulatory standards to include equipment, process, and product.
- Summarizes, analyses and in collaboration with the team, draws conclusions and makes appropriate decisions from test results and other related processes.
- Ensures relevant process monitoring/ controls are set up to maintain an effective and validated process.
- Conducts root cause analysis and implements corrective action in a timely manner.
- In charge of investigating customer complaints including carrying out failure mode analysis and executing required CAPAs specific to complaint.
- Carry out audits, including closing out audit findings to determine the correct preventative action.
- Collaborate with suppliers to make sure their quality standards are in line with the company.
- Maintenance of an effective quality management system in compliance with relevant regulatory requirements, including ISO13485.
- Engineering, Quality Assurance, or equivalent Science Degree.
- Minimum of 3 years post qualification experience in a quality environment with proven quality assurance experience within a Medical Device or regulated environment.
- Driving licence required to travel between sites if required.
- Ability to demonstrate knowledge of medical device quality & regulatory systems and medical device directive (EN ISO13485, MDD and FDA CFR 820).
- An analytical approach to problem solving.
- A self-starter that applies their own initiative.
- A team player, who works well in a small team environment.
- A good communicator who can effectively convey his/her ideas and requirements across all levels in the CAPA, Auditing and Risk Management experience per ISO 14971.
- Detailed knowledge of the regulatory environment in which the business operates including FDA, European and other International Regulatory requirements.
- Attention to detail while maintaining awareness of longer-term.
- Excellent interpersonal skills, a demonstrated ability to influence his/her peers and place quality at the forefront of everyone's daily agenda.
- Excellent organisational skills and ability to track and drive activities to closure.
- Displays capacity to maintain the highest levels of confidentiality internally and ability to manage multiple projects.
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.