Quality Engineer

Providien Thermoforming LLC; San Diego (CA); On-site; USD 70,000 - 110,000; Full time

Job summary

Providien Thermoforming is seeking a Quality Engineer I to lead and support quality activities on the shop floor. You will oversee inspections, audits, CAPAs, and process improvements for thermoformed components across medical device and aerospace markets.

Ideal candidates have a technical engineering background, ISO 13485 knowledge, and hands-on experience with quality tools, PPAPs, and FMEA. This role emphasizes data-driven problem solving and cross-functional teamwork.

Qualifications

• Bachelor’s degree in engineering or sciences.
• 5+ years' technical engineering experience preferred.
• 3 years manufacturing experience preferred.
• Knowledge of ISO 13485:2016 and related standards preferred.
• Experience in medical device, aerospace, or plastics/thermoforming industries preferred.

Responsibilities

• Provide daily quality support to manufacturing and engineering, including inspection, assembly, packaging and shipping.
• Investigate nonconforming products, scrap, rework and customer complaints; identify root causes and corrective actions.
• Lead or support CAPAs using 5 Whys, fishbone diagrams, and data analysis.
• Develop and maintain inspection plans, work instructions, acceptance criteria and manufacturing quality records.
• Review production documentation for GDP compliance and accuracy.
• Partner with manufacturing and engineering on process changes, validation, risk assessment and FAI.
• Use trend data and quality metrics to identify recurring issues and drive improvements.
• Support supplier quality activities and corrective actions.
• Participate in internal, customer and ISO 13485 audits; help prepare responses and close findings.
• Train and coach employees on quality requirements and procedures.
• Develop and deliver quality training materials to raise awareness.
• Review customer specifications; participate in FMEAs, DOE, PPAPs and CAPAs.
• Continuously improve quality systems and processes.

Skills

Attention to detail

Team collaboration

English communication

Education

Bachelor's degree in engineering or sciences

5+ years in technical engineering

3 years manufacturing experience

CQE or CQPA certification

Six Sigma Green Belt

Tools

MS Office Suite

SharePoint

ERP systems

GD&T

Blueprint reading

ASME Y14.5M

Job description

Description

Summary

The Quality Engineer I provides quality leadership and technical support to their Value Stream Team and quality technicians within Providien Thermoforming’s manufacturing operations. Working under the guidance of the Quality Manager, this role plans, initiates, coordinates, and evaluates activities related to the application, development, and maintenance of quality tasks, processes, and systems for thermoformed products. The primary responsibility of this role is to ensure that thermoformed components and assemblies meet required quality standards, customer expectations, and applicable regulatory requirements across our medical device, aerospace, and industrial markets.

Essential Job Functions

• Provide daily quality support to manufacturing, Engineering, including inspection, assembly, packaging and shipping operations.
• Investigate nonconforming products, scrap, rework, and customer complaints; identify root cause and implement effective corrective actions.
• Lead or Support CAPAs using tools such as 5 whys, fishbone diagrams, and process data analysis.
• Develop and maintain inspection plans, work instructions, acceptance criteria and manufacturing quality records.
• Review production documentation for completeness, accuracy and compliance with GDP.
• Partner with manufacturing and engineering teams on process changes, validation activities, risk assessment and FAI.
• Use trend data, defects rates, and quality metrics to identify recurring issues and measure improvement.
• Support supplier quality activities, including evaluation of supplier non-conformances and corrective actions.
• Participate in internal, customers and ISO 13485 audits; help prepare responses and close finding on time.
• Train and coach employees on quality requirements and practical application of procedures on the manufacturing floor.
• Develop and implement standards and methods for inspecting, testing, and evaluating thermoformed products and components.
• Develop and deliver quality training materials to increase awareness across the Value Stream Team.
• Review of customer specifications
• Participate in the design and process of FMEAs, Design of Experiments, PPAPs, Process/Product Capability Studies, and Product Liability Meetings.
• Continuously improve quality systems and processes.

Other duties as required in support of the department and the company.

Supervisor Responsibilities

This role does not include supervisory responsibilities over other employees. The Quality Engineer provides functional quality leadership and technical guidance to quality technicians within their assigned Value Stream Team.

Requirements

Qualifications

To perform this role successfully, an individual must be able to satisfy each essential function listed above. The requirements below represent the knowledge, skills, and abilities needed. Reasonable accommodations may be made for individuals with disabilities.

Education and Experience

• Bachelor’s degree in engineering or sciences, or 5+ years of experience working in a technical engineering role.
• Minimum of 3 years of experience in manufacturing preferred.
• Experience in Root Cause Analysis investigation (5 Whys, Fishbone, 8D, etc.) is preferred.
• Knowledge of ISO 13485:2016 and other relevant quality standards preferred
• Proven experience in a manufacturing quality control role.
• Background in medical device, aerospace, or plastics/thermoforming manufacturing industries is preferred.

Certificates, Licenses, and Registrations

• ASQ Certified Quality Engineer (CQE) or Certified Quality Process Analyst (CQPA) preferred.
• Six Sigma Green Belt preferred.

Language Requirements

• Excellent verbal and written communication skills in English are required.

Mathematical Skills

• Basic arithmetic: add, subtract, multiply, and divide whole numbers, fractions, decimals, and percentages.
• Statistics: interpret and analyze numerical data using statistical methods.
• Basic algebra: manipulate symbols and equations to find unknown values, express relationships, and model situations.
• Basic geometry: understand and work with shapes, angles, lines, and planes.
• Basic trigonometry: understanding essential trigonometric functions and how they relate to engineering drawings and specifications.

Technical Skills

• Proficient in MS Office Suite and SharePoint.
• Able to learn new business systems and associated software efficiently.
• Knowledge of ERP systems preferred.
• Excellent knowledge of blueprint reading, Geometric Dimensioning & Tolerancing (GD&T), and ASME Y14.5M.
• Excellent analytical, problem-solving, and attention-to-detail skills.
• Strong team player with the ability to collaborate across departments.
• Strong communication skills to effectively convey standards and procedures.
• Reliable and flexible to work additional hours on short notice to complete orders or special projects to meet customer or internal demands.
• Able to work independently with minimal supervision.

Physical Demands

The employee must be able to sit, stand, and walk throughout the workday. They frequently use their hands to handle objects and must communicate verbally. The role may also require reaching, crouching, stooping, and occasionally lifting objects up to 50 pounds. Specific vision abilities required include close, distance, color, and peripheral vision, depth perception, and the ability to adjust focus. Reasonable accommodation will be provided in accordance with ADA regulations.

Work Environment

Work is performed on the production floor of a manufacturing facility. Conditions may include exposure to machinery, noise, temperature variation, and other physical workplace factors. A culture of safety, teamwork, and continuous improvement is expected.

Environmental Policy

Providien Thermoforming is committed to minimizing the environmental impact of its operations, activities, and products. We comply with all applicable environmental regulations, work to prevent pollution, and continuously improve our environmental performance. Our Environmental Management System provides a framework for setting and reviewing environmental objectives and targets.

Personal Protective Equipment Requirements

• Safety toe footwear meeting ASTM F-2412-2005, ANSI Z41-1999, or ANSI Z41-1991 standards in designated areas.
• ANSI Z87.1 safety-rated clear glasses in designated areas.
• Hearing protection in designated areas.
• Compliance with applicable Job Safety Analysis (JSA) requirements.

Travel

Approximately 15% travel is expected for this role.

Providien Thermoforming does not accept unsolicited resumes or candidate submissions from external recruiters or staffing agencies for this position. Any resumes submitted without a signed agreement in place will be considered the property of Providien Thermoforming, and no placement fee will be paid.