Manufacturing Quality Engineer

SHIFT: 6am – 2:30pm, M-F. Saturdays on an as-need basis
SALARY RANGE: $90k – $110k
LOCATION: Hawthorn, CA

What You Will Do

• Leads or co-leads quality initiatives that align with site and corporate quality strategies, ensuring consistent adoption and measurable improvement.
• Provides direction, coaching, and technical mentorship to engineers, inspectors, and cross-functional partners to build capability and strengthen overall quality culture.
• Acts as a key decision-maker in escalated quality situations, balancing customer expectations, compliance requirements, and operational needs.
• Supports the Quality Manager in site-level planning, audits, and strategic reviews, stepping in as a delegate when needed.
• Drives cross-functional alignment during investigations, validations, and change management activities, ensuring teams stay focused, informed, and progressing toward resolution.
• Provides and documents training on standard work instructions, policies, and procedures to ensure team members have the required knowledge and skills before independent work.
• Uses quality tools such as process flowcharting, Pareto analysis, statistical tests, DOE, SPC, GR&R, and trend analysis techniques to implement improvements.
• Acts as a customer liaison and processes customer quality complaints, as needed.
• Collects, analyzes, and presents data using statistical methodology.
• Assists suppliers with interpretation of quality requirements.
• Supports development of QMS deliverables/APQP, including complaint analysis, risk analysis, FMEA, CAPA, and process/equipment/software verification/validation.
• Plans and/or conducts IQ, OQ, and PQ validations.
• Determines machine and/or process capability through Process Capability studies.
• Develops inspection criteria linking customer requirements to manufacturing processes, identifying key characteristics, sampling plans, and gauging.
• Interfaces with customer contacts to clarify requirements.
• Leads productivity and continuous improvement projects.
• Monitors engineering production processes for compliance with internal/external requirements.
• Participates in pre- and post-production launch reviews.
• Performs internal audits, reviews data, and prepares reports.
• Recommends updates to quality or production standards to optimize product quality.
• Reviews and approves product, process, and document change requests.
• Reviews drawings for correct GD&T, specification usage, and key characteristics for inspection planning.
• Supports measurement and analysis of key performance metrics.
• Collaborates with cross-functional teams to address production and quality issues.
• Creates and manages training course structures and programs.
• Reinforces safety expectations and reports safety concerns.
• Supports quality and compliance by following all QMS procedures, work instructions, and forms.

Education Qualifications

• Bachelor of Science (B.S.) — Required
• Master of Science (M.S.) — Preferred

Experience Qualifications

• 5+ years of experience — Required
• 5+ years in a manufacturing environment — Preferred
• Experience in medical device manufacturing — Preferred
• Experience leading a team — Preferred
• Experience managing change in a complex environment — Preferred

Licenses & Certifications

• Any Quality Certification — Preferred

Knowledge & Skills That Enable Success

• Operational Functions — Extensive Experience
• Quality Management — Extensive Experience
• Process Management — Working Experience
• Communication — Working Experience
• Accuracy & Attention to Detail — Working Experience
• Manufacturing Safety — Extensive Experience
• Lean Manufacturing — Working Experience
• Statistical Analysis & Measurement — Working Experience
• Production Part Approval Process (PPAP) — Working Experience
• Production Runs — Extensive Experience
• Final Inspection — Working Experience
• Computer Knowledge — Working Experience
• Customer Communication — Working Experience
• QSR & ISO — Extensive Experience
• Coaching — Working Experience
• Information Processing — Working Experience
• Lean Assessment — Extensive Experience
• Problem Solving — Working Experience

Physical Demands

• Must be able to remain in a stationary position — Frequently
• Must be able to move about inside the building — Occasionally
• Must be able to move equipment around the building — Rarely
• Must be able to ascend/descend stairs or ladders — Rarely
• Must be able to position self under/around/over equipment — Rarely
• Must be able to handle/adjust/inspect/position items/equipment — Rarely
• Must be able to communicate and exchange information — Constantly
• Must be able to perform repetitive handling/adjusting/inspecting tasks — Occasionally
• Must be able to visually detect information, writing, and defects — Constantly

Additional Requirements

• Candidates may be required to complete a pre-employment background check and drug screening.
• Applicants must be authorized to work for any U.S. employer. Visa sponsorship is not available.
• Candidates must provide proof of eligibility to work in the United States through eVerify.