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Quality Engineer - Validation - Tullamore
Eingestellt von Sentinel IT LLP
Gesuchte Skills: Engineering, Engineer, Support
Projektbeschreibung
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
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
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges