|Job Title:||Quality Engineer|
|Contact Name:||Cliona Gavin/Emma Brennan|
Our client is an internationally known medical device company currently operating in the vibrant city of Galway. The company are currently manufacturing cutting edge medical device technology and are looking for a confident and charismatic member to join their team. Along with competitive benefits and salary, this role provides the opportunity for further personal development and promotion within the company in the future.
The Quality Engineer is responsible for leading the quality engineering activities for manufacturing and production.
- Identifies and resolves complex exceptions to work assignments.
- Summarizes, analyses, draws conclusions and makes appropriate decisions from test results or other process related findings.
- Has the responsibility and independent authority to make decisions related to product quality, including the disposition of the non-conforming product.
- Participates in Customer Complaints investigation for areas under their control.
- Continually seeks to drive improvements in product and process quality.
- Knowledgeable on QSR and ISO/MDD standards, constantly promoting awareness of best industry practices, making an appropriate decision on a daily basis utilizing the quality engineering manager/site QA Director as the final arbitrator on critical quality decisions.
- Fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints.
- Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
- Knowledgeable on Risk Management, BSEN 14971 requirements.
- Compiles and analyses operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
- May participate directly in a new product/technology transfer to ensure compliance to all internal and regulatory requirements.
- Uses knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality.
- Gives technical guidance to Associate Quality Engineer, Technician and Inspection staff.
- Is a good team member, fully motivated to achieve and demonstrate best practices in line with the department and Site objectives.
- Deals with suppliers, other engineering disciplines within and outside of the Site and customers should the need arise.
- Is familiar with internal auditing processes
Skills, Experience and Qualifications:
- A degree qualification in engineering with at least 3-5 years of experience in a similar role.
- Ability to work on own initiative.
- Strong team member with the ability to identify and drive the implementation of innovative quality improvements.
- Excellent interpersonal and organisational skills. Ability to communicate effectively at all levels of the company.
- Relevant computer skills.