Specialist, Quality Engineer
About The Position
The Specialist, Quality Engineer is responsible for designing, developing, and implementing standards, methods, and procedures for inspecting, testing, and evaluating the precision and accuracy of company products in compliance with contractual and regulatory requirements. The role analyzes reported nonconformities and discrepancies involving assembly, processes, mechanical, electrical, and electro-mechanical systems, as well as field and clinical data. It further investigates causes, develops dispositions, and recommends corrective action plans. The position leads material review board (MRB) and Process Failure Mode Effects Analysis (PFMEA) activities, interfaces with manufacturing, engineering, customer, vendor, and subcontractor representatives to ensure requirements are met, conducts program quality cost account management, and manages supplier corrective actions. It serves as the primary quality-related interface to customers and suppliers. This experienced professional role requires proficient knowledge of its job area and practical project-management knowledge. The employee may manage projects or processes with general supervision, recommend system and process enhancements, and work toward operational targets for programs and projects with moderate impact on departmental results. The role communicates and explains operational processes, practices, and procedures to internal and external contacts and may work to justify and gain cooperation regarding them.
Requirements
- Bachelor’s degree and a minimum of 4 years of prior relevant experience; or a graduate degree and a minimum of 2 years of prior related experience; or, in lieu of a degree, a minimum of 8 years of prior related experience.
- Proficient knowledge of the job area.
- May have practical knowledge of project management.
Nice To Haves
- Experience leading root cause and corrective action (RCCA) activities from cradle to grave.
- Experience leading and auditing QMS entries.
- Previous material review board (MRB) experience.
- Experience with Advanced Product Quality Planning (APQP), Zero Defect Plan (ZDP), and Statistical Process Control (SPC).
- Lean or Six Sigma certification.
- American Society for Quality (ASQ) certification.
Responsibilities
- Design, develop, and implement standards, methods, and procedures for inspecting, testing, and evaluating product precision and accuracy in compliance with contractual and regulatory requirements.
- Analyze reported nonconformities and discrepancies related to assembly, processes, mechanical, electrical, and electro-mechanical systems, field data, and clinical data.
- Investigate causes of discrepancies and nonconformities, develop dispositions, and recommend corrective action plans.
- Lead material review board (MRB) and Process Failure Mode Effects Analysis (PFMEA) activities.
- Interface with manufacturing, engineering, customers, vendors, and subcontractors to ensure requirements are met.
- Conduct program quality cost account management and manage supplier corrective actions.
- Serve as the primary interface to customers and suppliers for quality-related matters.
- Manage projects or processes with general supervision and work toward operational targets for programs and projects.
- Recommend enhancements to systems and processes.
- Explain and interpret operational processes, practices, and procedures to others inside and outside the job area; work to justify and gain cooperation regarding them.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
