Quality Assurance Engineer at NIHON KOHDEN OrangeMed in Santa Ana, CA

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 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.

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.

Requirements

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

Skills

Required

• FDA 21 CFR Part 820
• ISO 13485
• ISO 14971
• Medical device quality systems
• NCR/NMR
• Complaint investigations
• Validations
• Supplier quality
• Audits
• Statistical analysis
• Sampling plans
• SPC

Benefits

• 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.