Quality Engineer

GCM Medical and OEM, Inc.; San Jose (CA); On-site; USD 85,000 - 120,000; Full time

Job summary

GCM Medical and OEM, Inc. is seeking a Quality Engineer to analyze trends, drive process improvements, and lead major quality initiatives in our manufacturing environment in San Jose, CA.

The role emphasizes coordinating corrective actions, performing root-cause analyses, and ensuring compliance with quality systems. Candidates should have 3–6 years of QA experience and an Associate or Bachelor’s degree in a technical field.

Qualifications

• Associate or bachelor’s degree in a technical field or related discipline.
• Relevant experience in Quality Assurance within manufacturing or medical device environments.
• Lean Six Sigma knowledge or certification is a plus.

Responsibilities

• Coordinates with customers on quality concerns and leads improvement projects.
• Leads corrective actions using 8D, 5-Why and fishbone analysis.
• Analyzes system data to identify major contributors to poor performing processes.
• Proactively identifies potential failure modes and recommends preventive actions.
• Evaluates project performance during and after completion.
• Leads cross-functional teams to develop and improve systems and processes.
• Creates PFMEA, MSA, Control Plan and capability studies for deliverables.
• Compiles PPAPs, defect containment, and root cause analyses.
• Analyzes production and supplier nonconformance data to determine root causes.
• Reviews customer returns to determine underlying issues.
• Improves QMS documents, procedures, forms and work instructions.
• Collaborates with suppliers, engineering, maintenance, purchasing, and operations to resolve issues.
• Leads supplier surveillance and on-site assessments of materials and processes.
• Issues, tracks, verifies root cause solutions, and closes corrective actions.

Skills

Quality Assurance

Process Improvement

Data Analysis

Cross-functional Collaboration

Education

Associate degree

Bachelor’s degree

Tools

PFMEA

MSA

Control Plan

Capability Studies

8D Problem Solving

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 REQUIREMENTS:

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