Quality Assurance Engineer

NIHON KOHDEN OrangeMed; Santa Ana (CA); On-site; USD 85,000 - 123,000; Full time

Job summary

NIHON KOHDEN OrangeMed is seeking a Quality Assurance Engineer III to support and improve product quality, manufacturing processes, and Quality Management System compliance in a regulated medical device environment.

This role provides advanced quality engineering support for new product development, sustaining engineering, supplier quality, and manufacturing operations, serving as a technical resource and leading complex quality initiatives.

Qualifications

• Bachelor’s degree in engineering or related technical field.
• 3–5 years of quality engineering experience in a regulated environment (medical device preferred).
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971.
• Experience with NCR/NMR, complaint investigations, validations, supplier quality, and audits.
• Experience supporting product development and design control activities preferred.
• Knowledge of statistical analysis, sampling plans, SPC, and quality data trending.

Responsibilities

• Ensure quality system processes are in compliance with US-FDA, MDD/MDR, ISO 13485 and other country-specific medical device regulations.
• Provide advanced quality engineering support for manufacturing operations to meet specifications, regulatory requirements, and quality standards.
• Establish and maintain the non-conforming material system with technical justification and risk assessment.
• Participate in material review board meetings for nonconforming materials and root cause analyses.
• Collect and trend key quality indicators for management review.
• Develop quality plans for new processes or process improvements.
• Support manufacturing in-process validation activities and change control.
• Facilitate receiving inspection, first article inspection, and calibration activities.
• Support supplier management including supplier approvals, audits, and corrective actions.
• Lead corrective/preventive action systems and perform root cause analysis with effectiveness checks.
• Conduct internal quality audits to ensure compliance with Quality System and regulations.

Skills

Analytical skills

Problem-solving

Communication

Cross-functional collaboration

MS Office

Quality management software

Education

Bachelor's degree in engineering or biological sciences

Tools

Quality management software

Job description

The Quality Assurance Engineer is responsible for supporting and improving product quality, manufacturing processes, and Quality Management System compliance within a regulated medical device environment. This role provides advanced quality engineering support for new product development, sustaining engineering, supplier quality, and manufacturing operations. The QA Engineer III serves as a technical resource, leads complex quality initiatives, and drives continuous improvement efforts to support the quality, reliability, and performance of the company products.

Duties and Responsibilities

• Assure quality system processes are in compliance with US-FDA, MDD/MDR, ISO 13485 and other applicable country specific medical device regulations.
• Provide advanced quality engineering support for manufacturing operations to ensure products meet established specifications, regulatory requirements, and quality standards.
• Establish and maintain the non-conforming material system for assigned product line(s). Responsible for the appropriate technical justification and risk assessment for product deviations.
• Participate in material review board meetings to ensure the appropriate disposition of nonconforming materials, components, and products. This includes reviewing inspection data, deviation reports, root cause analyses, and proposed corrective actions to verify compliance with quality standards, regulatory requirements, and internal procedures.
• Collection and trending of key quality indicators for management review.
• Develop quality plans for implementation of new processes or improvements to existing processes.
• Support manufacturing in-process validation activities, including manufacturing risk assessments, document change control, and transfer of products from development to manufacturing.
• Facilitate receiving inspection, first article inspection, and calibration activities, including establishing inspection requirements for materials and defining calibration requirements for measuring equipment and test fixtures as needed.
• Support the control of suppliers by assisting with supplier approval, supplier audits, supplier monitoring and supplier corrective action.
• Responsible for the corrective/preventive action system for assigned CA/PAs. Work with responsible engineering personnel to perform root cause analysis, develop and implement action plans, and follow-up on implementation and effectiveness of actions taken.
• Conduct internal quality audits to ensure compliance with the Quality System and regulatory requirements.
• Perform other duties as assigned based on business needs.

Qualifications

Education and Experience

• Bachelor’s degree in engineering, biological science or a related technical field required.
• Minimum three-five years of quality engineering experience in a highlighted regulated environment, medical device preferred.
• Strong working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and medical device quality systems.
• Experience with NCR/NMR, complaint investigations, validations, supplier quality, and audits.
• Experience supporting product development and design control activities preferred.
• Knowledge of statistical analysis, sampling plans, SPC, and quality data trending preferred.

Skills & Abilities

• Strong analytical and technical problem-solving skills.
• Self-motivated, detail-oriented, and well-organized with excellent communication skills, both written and verbal.
• Work under minimal supervision, using experience and sound judgement to plan and accomplish assigned goals.
• Ability to read and interpret engineering drawings, specifications, and regulatory requirements.
• Ability to work collaboratively with cross-functional team members.
• Proficient with Microsoft Office and quality management software systems.

Desirable Accreditations/Knowledge

• ASQ certifications such as CQE, CQA, or CSSBB preferred.
• Certified ISO 13458 / MDD lead auditor preferred.

Compensation

The anticipated range for this position is $85,000.00 to $123,000.00 at an annual base. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, experience and location.

Working Conditions

• A Quality Assurance Engineer usually works in an office environment which includes a laboratory and manufacturing areas. Occasional domestic travel may be required for supplier visits or audits.
• A Quality Assurance Engineer works a standard work schedule and may need to extend hours as needed to meet company deliverables and deadlines.

Physical Requirements

Ability to speak, sit, stand, walk production areas, and use a computer for extended periods.

May occasionally lift and carry up to 50 lbs.