Quality Engineer

GCM Medical & OEM INC; Union City (CA); On-site; USD 85,000 - 120,000; Full time

Job summary

GCM Medical & OEM INC in Union City, CA is seeking a Quality Engineer to analyze trends and determine root causes of quality deficiencies, leading improvement projects.

You will create process metrics, coordinate major production approvals, and conduct internal audits to ensure quality objectives are met and sustained.

Qualifications

• 3-6 years of progressive Quality Assurance experience.
• Relevant industry experience.
• Associate or bachelor’s degree.

Responsibilities

• Coordinates with customers on quality concerns, reports, improvement projects.
• Leads corrective actions using 8D, 5-Why and fishbone analysis.
• Analyzes system data to determine major contributors to poor performing processes.
• Proactively determines possible failure modes and suggests preventive actions.
• Evaluates project performance during and after completion.
• Leads cross functional teams to develop and improve systems.
• Coordinates PFMEA, MSA, Control Plan, and Capability Studies for deliverables.
• Compiles PPAPs, defect containment, and root cause analysis.
• Analyzes production and supplier nonconformance data to determine cause.
• Investigates customer returns to identify root causes.
• Improves QMS documents including procedures, forms, and work instructions.
• Collaborates with suppliers, product/ process engineering, maintenance, purchasing, and operations.
• Leads in vendor surveillance and on-site assessments of materials and processes.
• Responsible for issuing and tracking root cause solutions and closing supplier actions.
• Performs other related duties assigned.

Skills

Quality Assurance experience

Industry experience

English fluency

Education

Associate or Bachelor's degree

Bachelor’s degree in a technical field

Tools

Lean Six Sigma Green Belt

Job description

SUMMARY

The Quality Engineer is responsible for analyzing trends, determining underlying causes to systemic quality deficiencies, and leading improvement projects. Responsibilities also include creating process metrics, coordinating major production approval deliverables, and conducting internal audits.

JOB RESPONSIBILITIES:

• Coordinates with customers on quality concerns, reports, improvement projects, etc.
• Leads corrective actions using formal methodologies such as 8D, 5-Why and fishbone analysis
• Analyzes system data to determine major contributors to poor performing processes
• Proactively determines possible failure modes in the manufacturing process and suggests steps for preventive action
• Evaluates project performance while the project is active and upon project completion
• Leads cross functional teams in developing and improving systems
• Coordinates and creates PFMEA, MSA, Control Plan, and Capability Studies for customer deliverables and to improve manufacturing processes
• Compiles PPAPs (Productive Part Approval Process), defect containment, and root cause analysis
• Analyze production and supplier nonconformance data to determine cause
• Analysis customer returns to determine underlying root causes
• Improves QMS documents including procedures, forms, work instructions
• Collaborate with external suppliers, product engineering, process engineering, maintenance, purchasing, and operations to resolve issues or non-conformances with product and processes.
• Lead in vendor surveillance and on-site assessments of purchased materials and processes.
• Responsible for issuing, tracking, verifying root cause solutions, and closing supplier corrective actions.
• Must be a team player as measured by his/her peers
• Performs other related duties assigned

Requirements

QUALIFICATIONS AND SKILLS:

REQUIRED

• 3-6 years of progressive Quality Assurance experience
• Relevant industry experience
• Associate or bachelor’s degree

DESIRED

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

PHYSICAL REQURIEMENTS:

Sitting/Standing/Walking

• Approximately 75% is spent seated at a desk, working on the telephone or at a computer terminal
• Approximately 25% is spent bending, squatting, standing, or moving about the work area, including in manufacturing environments

Speaking/Hearing

• Ability to speak, read and write English fluently
• Clear diction, correct grammar and acute hearing are necessary for effective communication with clients, vendors, management, and other employees

Vision

• Corrected vision close to 20/20 is necessary to effectively use computer screens, read reports and responding to correspondence and emails

Working conditions are normal for an office environment. Work may require occasional weekend and/or evening work