Description
Quality Engineer - Validation - Tullamore
My client are seeking an experienced Validation Quality Engineer who can complete validation activities associated with plant projects and initiatives to improve process capability.
JOB FUNCTIONS:
- Develop protocols and reports in line with corporate validation requirements.
- Analysis of data using process capability tools, such as Minitab.
- Working with engineering groups to establish process capability studies.
- Use root cause analysis tools and techniques, with a specific focus on process capability, to support the ongoing drive to improve overall site quality performance.
- Execution of assigned projects within cost and schedule requirements.
- Working with team of engineers assisting them in bringing projects to successful conclusion.
- Develop reporting methodologies for Cpk, Ppk metrics for the top product codes at the plant. This may include the implementation of SPC.
- Present and defend validation approaches and results to all external and corporate auditors.
- Actively participate in and support company and plant wide initiatives including six-sigma, lean, safety and cost reduction.
- Assist in the maintenance of a safe company culture by working within the company's health and safety guidelines at all times and reporting any equipment or process problems in line with plant escalation procedures
- Identify continuous improvements opportunities where possible and take part in improvement projects as assigned
QUALIFICATIONS
- Engineering/Technical degree.
- A Six-Sigma certification is desirable but not essential.
SKILLS & COMPETENCIES REQUIRED
- A minimum of 2 years experience working in the medical device industry with strong focus on validation activities and process capability
- Experience working in a quality engineering role with active involvement with the manufacturing floor.
- Audit facing experience with FDA and Notified Bodies essential.
- Proven proficiency in statistical data analysis.
- Experience of working within a regulated industry with knowledge of MDD (Medical Device Directive), ISO 13485 (Quality Management Systems), FDA, cGMP, and Risk Management (ISO 14971)
- Experience in a supervisory or leadership role with people management responsibility
- Ability to work with cross-functional teams, including production, quality, engineering and materials.
- Experience working with moulding and extrusion processes and with automated assembly processes is desirable.
Please apply now for further information