Senior Quality Engineer. Cork. €40~€50 per hour.
Initial 12-month contract. Onsite role.
The Senior Quality Engineer will lead the QA element of process/technological improvements/product transfers in conjunction with local Quality, and Operations personnel ensuring timely communication to all stakeholders to effect successful project completion.
MAIN DUTIES & RESPONSIBILITIES
- Represent Quality as part of a cross-functional team to ensure delivery of projects into production with the highest level of quality, compliance, and adherence to timelines.
- Review, compile and execute validation protocols for new equipment/processes and software.
- Ensure correct implementation as per standard validation procedures. Re-validate as required due to engineering change, deviation analysis or upgrade in systems and material.
- Develop/review and utilise PFMCA and other QA risk analysis techniques to minimise potential risk during development/implementation activity.
- Ensure daily and project compliance with all Documented Quality Systems during all day-to-day activities
- Assist in problem-solving for new processes and established production processes enabling a reduction in compliance risks, scrap, and reprocessing.
ESSENTIAL QUALIFICATIONS & EXPERIENCE
- A degree level 8 or similar qualification.
- Minimum 3 years of experience in a Quality role within a regulated industry.
- Proven knowledge and ability regarding product verification and process validations.
- Works and communicates well with others in a team environment.
- Experience working in both an FDA and European regulatory environment is preferred with an in depth knowledge of 21 CFR 820, CFR 11 and European regulations associated with the medical device industry.
- A thorough understanding of GMP/ISO and validation regulations.
- Technical training (Six Sigma Black Belt / Statistical Engineering) and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
- Problem solving engineering expertise (Six Sigma, SE or A3)
To apply for this job email your details to email@example.com.