Quality Engineer

GCM Medical and OEM, Inc.•Union City, CA

25d

About The Position

The Quality Engineer analyzes trends and determines underlying causes of systemic quality deficiencies, then leads improvement projects. The role creates process metrics, coordinates major production approval deliverables, and conducts internal audits. It works with customers, suppliers, and cross-functional internal teams to resolve quality concerns and improve products, processes, and quality management systems. The position also includes evaluating project performance, identifying potential manufacturing failure modes, coordinating quality planning and capability studies, compiling approval and containment documentation, and tracking supplier corrective actions through verification and closure. Other related duties may be assigned.

Requirements

3–6 years of progressive Quality Assurance experience.
Relevant industry experience.
Associate or bachelor’s degree.
Ability to speak, read, and write English fluently.
Clear diction, correct grammar, and acute hearing for effective communication with clients, vendors, management, and other employees.
Corrected vision close to 20/20 to use computer screens, read reports, and respond to correspondence and emails.
Ability to sit, stand, walk, bend, squat, and move about the work area, including in manufacturing environments.

Nice To Haves

Bachelor’s degree in a technical field.
Lean Six Sigma Green Belt.

Responsibilities

Coordinate with customers on quality concerns, reports, and improvement projects.
Lead corrective actions using formal methodologies such as 8D, 5-Why, and fishbone analysis.
Analyze system data to identify major contributors to poorly performing processes.
Proactively identify possible manufacturing-process failure modes and suggest preventive actions.
Evaluate project performance while projects are active and after completion.
Lead cross-functional teams in developing and improving systems.
Coordinate and create PFMEA, MSA, Control Plans, and Capability Studies for customer deliverables and manufacturing-process improvement.
Compile PPAPs (Productive Part Approval Process), defect containment, and root cause analyses.
Analyze production and supplier nonconformance data to determine causes.
Analyze customer returns to determine underlying root causes.
Improve QMS documents, including procedures, forms, and work instructions.
Collaborate with external suppliers and product engineering, process engineering, maintenance, purchasing, and operations to resolve product and process issues or non-conformances.
Lead vendor surveillance and on-site assessments of purchased materials and processes.
Issue, track, verify root cause solutions, and close supplier corrective actions.
Be a team player as measured by peers.
Perform other related duties as assigned.