Product Quality Engineer

Product Quality Engineer

Location: Salem, NH, US, 03079

Work Arrangement: Hybrid

The Role:

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's will also utilize quality engineering principles and problem-solving skills to support, improve, and maintain products/processes that are aligned with the overall quality and business vision. He/she will utilize appropriate risk management tactics to prevent unanticipated failure modes and improve capability of processes. This person 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 maintains compliance to relevant standards. This person will possess a wide knowledge of ISO/TS/ASTM, Machine directive and agency compliance requirements

Job 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 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.
• Champions compliance to applicable Global Regulations and standards, and provide support during internal and external audits.
• 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.
• 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
• Approve IQ, OQ, PQ, TMV or Software Validation for existing products
• Partners with Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed.
• Conduct stakeholder analysis to ensure that customer CTQs are known and adequately addressed in product control plans
• Develop measurement systems/capabilities, destructive tests, non-destructive tests for manufacturing processes
• Support Development of control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.
• Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
• Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
• Develop, interpret and implement standard and non-standard sampling plans
• Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.
• Accountability and ownership for sampling plans of all types including acceptability of risk given the product classification, potential defect types, defect frequency, severity, process capability, process controls, etc. including assessing, applying and interpreting acceptance sampling standard for manufacturing data.
• Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits.
• Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs
• Ensures effective quality strategies are created for the validation of test methods, process and design.
• Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and can present data that facilitates/drives decision making is preferred.
• Conduct Quarterly Value Stream Product Line reviews

Job Requirements:

• 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.
• 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.
• 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
• Excellent communication and presentation skills
• Statistical sampling and quality control methods
• Design of experiments
• CGMP's, QSR's, ISO, TS (auto), AS (Aerospace), FDA (food and Drug) and TQMS quality systems.
• Risk Management and Hazard Analysis techniques
• Data analysis
• Quality by Design (QBD ICHQ10)
• FMEA ASTM:J1739
• IQ, OQ,PQ and PV plans
• Excellent written and verbal communication, presentation and interpersonal skills
• Ability to effectively manage multiple priorities and projects
• Six Sigma Green or Black Belt preferred

The right candidate will be aligned to our values and culture:

• Collaborative entrepreneurial spirit
• Winning through customers
• High ethical standards, openness and trust
• Expectations for results
• Respect and value people

If you believe you match our values and have the experience we're looking for, apply! We can't wait to hear from you!