Position: Sr Quality Engineer (Joint)
Job Summary
The Quality Engineer provides comprehensive quality engineering support across the product lifecycle, ensuring robust processes, regulatory compliance, and continuous improvement within a highly regulated manufacturing environment.
Key Responsibilities Business & Continuous Improvement
- Drive quality improvement initiatives, including process and product characterization, to support continuous improvement and cost-reduction goals.
- Evaluate the effectiveness of PDCA, Six Sigma, Kaizen, Lean, and other improvement methodologies.
- Conduct benchmarking to identify and implement best-in-class quality practices.
- Support the development of quality engineering capabilities required for new product introductions and lifecycle management.
- Develop, implement, and sustain quality improvement plans.
Compliance & Regulatory
- Assess product and process compliance with applicable standards (e.g., QSR, ISO 13485, ISO/EN standards).
- Champion adherence to global regulatory requirements and support internal and external audits.
- Conduct periodic line audits to verify production controls (e.g., lot segregation) and ensure corrective and preventive actions are effective.
New Product & Process Introduction
- Collaborate with R&D and cross-functional teams to ensure proper application of design controls and risk management.
- Support design transfer activities and ensure quality requirements are embedded into new product and process introductions.
Product Quality, Disposition & Performance
- Support Material Review Board (MRB) activities and ensure timely disposition of non-conforming materials.
- Lead or support investigations, documentation, and approvals for non-conformances, CAPAs, and customer complaints.
- Maintain accountability for material identification, segregation, and defect classification within manufacturing.
- Evaluate the effectiveness of corrective and preventive actions and ensure root-cause investigations follow established processes.
- Own quality metrics, including monitoring and reporting leading and lagging indicators.
- Serve as a Subject Matter Expert (SME) for assigned quality systems and processes.
Product & Process Qualification
- Lead or support the development of validation strategies.
- Review and approve IQ, OQ, PQ, TMV, and software validation activities.
Production & Process Controls
- Partner with Global Supply Chain, Finished Goods, and suppliers to ensure proper application of process validation, process controls, and risk management.
- Develop and implement process monitoring and control methods aligned with product and process risk.
- Perform statistical and analytical evaluations to support process improvements and daily operations.
- Develop and interpret standard and non-standard sampling plans.
- Assess measurement systems, destructive and non-destructive testing methods, and overall measurement capability.
- Distinguish between common-cause and special-cause variation and evaluate the adequacy of process limits.
Risk Management
- Evaluate proposed process changes to ensure they do not increase risk or compromise compliance with QSR or other regulatory standards.
- Assess the need for risk-mitigation techniques based on product classification, defect types, severity, frequency, and process capability.
- Evaluate the effectiveness of previously implemented risk-mitigation actions.
Strategic Quality Leadership
- Develop and support quality strategies for test method validation, process validation, and design quality.
Core Competencies
- CAPA Management
- Non-Conformance (Client) Management
- Quality Auditing
- Complaint Investigation
- Validation (IQ/OQ/PQ/TMV)
- Risk Assessment & Mitigation
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
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