Job Title: Senior Quality Engineer
Location: Shannon, County Clare, Ireland
Employment Type: Full-Time, Onsite (5 days per week)
Opportunity Overview
Our Medical device industry Client is seeking an experienced Senior Quality Engineer to join their growing team in Shannon, County Clare. This pivotal role offers the chance to influence quality and regulatory excellence while driving continuous improvement across the site. With the potential to progress into a Quality Manager position within one year, this is a unique opportunity for an ambitious professional ready to take their career to the next level.
Key Responsibilities
The Senior Quality Engineer will:
1. Stay current with evolving quality systems standards and regulatory requirements.
2. Lead the Design Control Process from a Quality perspective, offering expert guidance to the Design and Development Team, including documentation such as FMEA, Quality Agreements, and Quality Plans.
3. Review and approve operational, test, and validation data to define technical specifications and performance standards for new or modified products and processes.
4. Investigate complex product quality issues, including CAPA, non-conformances, and audit observations. Employ advanced problem-solving techniques (5 Whys, 8D, A3) and deliver actionable recommendations.
5. Identify deficiencies in quality systems, propose corrective actions, and spearhead process improvements to ensure ongoing compliance.
6. Develop and communicate quality metrics (KPIs) to key stakeholders using effective presentations.
7. Manage records associated with Management Review Processes and support cross-functional compliance efforts, mentoring other departments on quality procedures.
8. Participate in and support internal and external audits, acting as a quality champion across the organisation.
9. Deliver training on Quality Management Systems, owning the Quality Induction process and coaching colleagues in quality best practices.
10. Utilise Six Sigma tools and Lean techniques to lead site-wide quality improvement programmes, educating colleagues in these methodologies.
11. Take ownership of assigned projects aimed at improving product quality, reducing costs, and enhancing processes, including inspection methods and SPC implementation.
12. Deputise for the Senior Quality and Regulatory Manager as required, showcasing leadership capability.
Essential Qualifications and Experience
To excel in this role, candidates should possess:
1. Academic Background: Bachelor’s degree in Quality, Engineering, or Science (Master’s degree advantageous).
2. Industry Experience: 5-8 years in the medical device sector.
3. Regulatory Expertise: Strong knowledge of Quality Management Systems (e.g., ISO9001, ISO13485, cGMP, CE, FDA, MDSAP) and global medical device regulations.
4. Problem-Solving Skills: Proven ability in CAPA investigations, complaint management, and applying structured methodologies like 8D and Six Sigma.
5. Audit Proficiency: Lead Auditor certification or substantial internal audit experience.
6. Technical Knowledge: Familiarity with Cleanroom technology, SMT, PTH, and IPC standards. Experience with QT9 is a distinct advantage.
7. Soft Skills: Exceptional written and verbal communication skills, proactive attitude, and ability to manage multiple priorities in a fast-paced environment.
8. Digital Skills: Proficiency in MS Word, Excel, and PowerPoint, with the ability to deliver impactful presentations.
9. Regulatory Compliance: Comprehensive understanding of QSR, ISO, and MDR requirements.
For further information on this role please contact Lisa Lawlor on 0868395533 or email stem@hero.ie
Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/
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