Description
MAIN DUTIES & RESPONSIBILITIES:- Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
- Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
- Conduct benchmarking to develop more effective methods for improving quality
- Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management. New Product/Process Introduction
- Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.
- Supports new product introduction as part of design transfer. Product Quality, Control & Disposition and Performance Standards
- Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
- Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
- Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality Product/Process Qualification
- Generate, review and approve IQ, OQ, PQ, TMV or Software Validation
Qualifications
- A minimum of a Bachelors Degree, preferably in Engineering or related technical field. Generally requires 4-6 years related experience.
- Experience working in both an FDA and European regulatory environment is preferred.
- This position will require relevant experience working in manufacturing/operations.
- In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
- Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC.
- Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.
- The ability to perform "hands on" troubleshooting and problem solving is required. The ability to think on the feet and providing sound judgment is highly desired.
- Good technical understanding of manufacturing equipment and processes is required.
- Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
ESSENTIAL:
- Engineering degree Quality / Manufacturing / Engineering and/or
- Minimum 2 - 3 years experience in Quality Assurance/Engineering
- Proven track record in Compliance & Continuous improvement projects
- Ability to interpret engineering drawings/specifications.
- Familiarity in areas of various Inspection Techniques.
- Process Excellence Green Belt/Black Belt
If you would like to hear more about this opportunity please contact me on or reply with a copy of your CV. We also offer shopping vouchers for any successful referrals so if you know of anyone who would be interested feel free to get in touch.