Markem-Imaje is looking for a Product Quality Engineer to maintain products/processes throughout the product lifecycle, support quality improvement initiatives, and ensure compliance with relevant standards and regulations.
Requirements
- Strong understanding of quality policies, ISO Standards.
- Strong knowledge of risk management.
- Strong knowledge in product/test method/process validations, and design controls.
- Strong knowledge in statistical process control and ability to apply advanced statistical techniques.
- Demonstrated use of Quality tools, principles and methodologies including lean and six sigma principles.
- Statistical sampling and quality control methods
- Design of experiments
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.
- Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management for assigned value stream.
- Review/analyze whether current product and processes (including actions or decisions conducted) comply to standards such as the ISO/TS/ASTM/FDA/EU machine directive etc.
- Supports new product introduction as part of design transfer.
- Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
- Approve IQ, OQ, PQ, TMV or Software Validation for existing products
Other
- Bachelors Degree in Scientific or Engineering discipline
- Minimum 5 years of quality engineering experience with a Bachelors degree. 7-10 years with an AS degree or 10-15 years of experience.
- Must be able to successfully work with all functional departments and all phases of company manufacturing and quality operations
- 4-8 years relevant experience with a focus on product quality and manufacturing quality
- 3-5 years as a Leader and facilitator of interdisciplinary project teams
