Onsite Quality Engineer – Medical Devices

ADP, Inc.; Vista (CA); On-site; USD 70,000 - 100,000; Full time

Job summary

ADP, Inc. in Vista, CA is seeking a Quality Engineer to uphold quality across product and process, applying ISO 13485 and FDA quality system requirements.

You will perform internal audits, investigate defects, and lead cross-functional quality improvements to ensure robust QMS and product quality across manufacturing and development. The role emphasizes data-driven analysis, corrective actions, and documentation management, with onsite duties and a focus on continual quality improvement within a

Qualifications

• Five to seven years of progressive Quality experience in a medical device or other regulated manufacturing environment.
• Working knowledge of ISO 13485, FDA medical device Quality System requirements, and Quality assurance and Quality engineering principles.
• Demonstrated experience with product and process investigations, root‑cause analysis, corrective action and Quality improvement.
• Demonstrated experience independently performing internal QMS audits and evaluating objective evidence against established requirements.
• Experience analyzing Quality and manufacturing data and applying specifications, inspection requirements, acceptance criteria, sampling methods and other product quality controls.
• Experience with controlled change in a regulated Quality Management System and working cross‑functionally with Manufacturing, Inspection, Engineering, Product Development and other operational functions.

Responsibilities

• Apply Quality System principles and requirements in accordance with Company procedures, ISO 13485 and applicable FDA medical device requirements.
• Serve as an internal QMS auditor, independently planning and performing assigned audits of Quality System processes and applicable business functions against ISO 13485, Company procedures and other applicable requirements; evaluate objective evidence, document findings and support appropriate follow‑up.
• Develop and maintain extensive knowledge of Company products, components, specifications, manufacturing processes, inspection requirements and known failure modes to support effective Quality evaluation and decision‑making.
• Investigate product defects and failures, including evaluation of returned product and relevant product, manufacturing, complaint and Quality history, to characterize failure modes, determine contributing factors and identify recurring or potentially systemic conditions.
• Collect, analyze and interpret product and Quality data to identify trends, variation, recurring conditions and potential quality signals and contribute to the development of meaningful data collection, analysis and reporting methods.
• Lead assigned corrective action, nonconformance, root‑cause investigation and Quality improvement activities or participate as an active member of cross‑functional teams responsible for evaluating and resolving Quality issues.
• Prepare and update controlled documents as assigned, including initiating change documentation, developing required revisions, obtaining appropriate technical and functional input, verifying proposed changes, evaluating impacts and related downstream activities and completing applicable requirements through the Company's self‑service documentation process.
• Support development and revision of inspection plans, acceptance criteria, sampling methods and other product quality controls associated with product, process, specification and controlled‑document changes.
• Provide backup support for Quality Inspection and other Quality workflows as needed, performing assigned activities in accordance with established procedures, specifications and acceptance requirements.
• Develop subject‑matter expertise and assume responsibility for assigned Quality System areas as knowledge, proficiency and organizational needs evolve.

Skills

Quality engineering

Auditing

Root-cause analysis

Data analysis

Cross-functional teamwork

Job description

ADP, Inc. in Vista, CA is seeking a Quality Engineer to uphold quality across product and process, applying ISO 13485 and FDA quality system requirements.

You will perform internal audits, investigate defects, and lead cross-functional quality improvements to ensure robust QMS and product quality across manufacturing and development. The role emphasizes data-driven analysis, corrective actions, and documentation management, with onsite duties and a focus on continual quality improvement within a