Description
I have an immediate opening for a Quality Engineer with a growing medical device company based in Galway. This is an great opportunity to join a growing company that offers an excellent work life balance for all employees.Candidates with good experience in Line support, problem solving, dealing with suppliers and auditing experience are highly desired.
Responsibilities:
- Assist the QA Group in establishing, implementing and maintaining the Quality System.
- Promotes compliance excellence within the company to customer requirements and applicable regulations QSR 21 CFR Part 820: 21 CFR Part 11, ISO13485: 2003: CAN/ cSA ISO13485: CMDR and Japanese MHLW's Ministerial Ordinance of GMP/ QMS.
- Participate in new product / technology development and supports the QA activities as part of the project team / extended team.
- Summarises, analyses and in conjunction with the team draws conclusions and makes appropriate decisions from test results or other process related findings.
- Use statistics to demonstrate significance of data to meet sampling plans.
- Defines implements Quality Standards and specifications and helps to ensure that regulatory requirements are met.
- Compiles the required regulatory data to support new product submissions and notice of change.
- Conduct root cause analysis and implement corrective actions in a timely manner.
- Analyze failure, corrective and preventative actions.
- Continually seek to drive improvements in product and process quality.
- Conduct audits, including close out findings, creating audit findings reports and determine proper corrective actions. Perform incoming inspections as required.
- Support the quality management system to ensure that products and processes comply with the relevant product specifications.
- Create and maintain company quality documentation. Take responsibility for storage archiving and retrieving of quality documentation.
- Maintain the Supplier Quality system, conduct supplier audits as required and liaise with suppliers to address any customer complaints.
Requirements:
Qualification necessary: Primary Degree,
- Understanding of the FDA , European, Canadian, Japanese and other international regulatory requirements.
- Strong organisational interpersonal and influencing skills.
- Ability to coordinate multiple projects, set direction and drives innovation and change.
- Excellent written and oral communications.
This is an excellent opportunity to join a fantastic company in the Galway region, if you feel you are a good fit for this role and are interested in hearing more please apply directly to this advert or contact Derek Sheridan on to hear more about this opportunity.