Product Quality Engineer

Overview

Markem-Imaje is a trusted world manufacturer of product identification and traceability solutions, offering a full line of reliable and innovative inkjet, thermal transfer, laser, print and apply label systems. Markem-Imaje delivers fully integrated solutions that enable product quality and safety, regulatory and retailer compliance, better product recalls and improved manufacturing processes.

The Product Quality Engineer will utilize Quality Engineering tools and practices for the effective and efficient maintenance of products/processes throughout the product lifecycle. The PQI will utilize quality engineering principles and problem-solving skills to support, improve, and maintain products/processes aligned with the overall quality and business vision. This person will apply risk management tactics to prevent unanticipated failure modes and improve capability of processes.

They will support the Quality Operations Value Streams, partnering with Operations, Supply Chain, and Engineering in the transfer and validation of new processes and technologies at the manufacturing site. This person will apply quality, compliance and regulatory knowledge to support the product lifecycle and maintain compliance with relevant standards. They will possess broad knowledge of ISO/TS/ASTM, Machine Directive and agency compliance requirements.

• 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.
• Support the development of quality engineering and quality compliance with the right skill sets for new product introductions and product life cycle management for the assigned value stream.
• Review/analyze whether current product and processes (including actions or decisions conducted) comply with standards such as ISO/TS/ASTM/FDA/EU machine directive, etc.
• Champion compliance with applicable Global Regulations and standards, and provide support during internal and external audits.
• Support 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.
• Analyze/review effectiveness of preventive and corrective actions. Review root cause investigations according to an established process.
• Maintain accountability and ownership of quality metrics including leading and lagging indicators.
• Approve IQ, OQ, PQ, TMV or Software Validation for existing products.
• Collaborate with Global Supply Chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; investigate/correct process failures when needed.
• Conduct stakeholder analysis to ensure customer CTQs are known and addressed in product control plans.
• Develop measurement systems/capabilities, destructive tests, non-destructive tests for manufacturing processes.
• Support development of control plans aligned with product classification, potential defect types, defect frequency, severity, patient risk, process capability, and process controls.
• Develop, interpret and implement appropriate process monitoring and control methods aligned with risk levels.
• Collect data and perform analytical/statistical analyses to drive process improvements and day-to-day support.
• Develop and interpret standard and non-standard sampling plans.
• Assess effectiveness of measurement tools, destructive tests, non-destructive tests and measurement system analysis.
• Own sampling plans of all types, including acceptance sampling for manufacturing data.
• Assess and interpret common versus special cause variation in manufacturing and determine adequacy of current process limits.
• Document and assess whether proposed changes to a process will not increase risk beyond current controls or lead to non-compliance with required standards such as QSRs.
• Ensure effective quality strategies for validation of test methods, processes and designs.
• Strong knowledge of statistical software packages and ability to preview, graph and analyze data to support decision making is preferred.
• Conduct quarterly Value Stream Product Line reviews.

• Bachelors Degree in a 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.
• Strong understanding of quality policies and 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.
• Ability to work…