Quality Assurance Engineer II

The Quality Engineer II supports Quality Assurance and Quality Engineering activities to ensure compliance with ISO 13485, FDA regulations (21 CFR Part 820 - QMSR), and applicable regulatory requirements. This role is execution-focused and operates under general supervision within established quality system governance. The Quality Engineer II independently executes moderately complex quality engineering tasks and contributes to stabilization, remediation, and continuous improvement activities across the organization.

This role is expected to focus on a defined subset of quality activities at any given time, with responsibilities adjusted based on business priorities and individual experience.

• Investigate product, process, and supplier nonconformances using structured root cause analysis tools.
• Support development, implementation, and effectiveness verification of corrective and preventive actions (CAPA).
• Support complaint investigations and post-market quality activities in accordance with established procedures.
• Assist with remediation of legacy issues, open quality actions, and audit observations as assigned.

• Participate in product and process risk management activities in accordance with ISO 14971.
• Support validation activities, including process, equipment, software, and test method validation (IQ/OQ/PQ), and measurement system analysis (e.g., Gauge R&R).
• Support process verification and validation activities and assist with design-related quality activities as assigned.

• Support core QMS processes, including document control, training, internal audits, and quality record maintenance.
• Assist with internal, customer, and regulatory audits through documentation preparation and participation as assigned.

• Support supplier quality activities, including documentation review, performance monitoring, and issue resolution.
• Support process monitoring, KPI trending, and quality data analysis to identify risks.
• Contribute to continuous improvement initiatives through data analysis, process optimization, and enhancement of quality system effectiveness.

• Bachelor’s degree in engineering or science (Mechanical, Industrial, Biomedical, or related
• 3–6 years of Quality Engineering or Quality Assurance experience in a regulatory manufacturing environment (medical device experience strongly preferred).
• Demonstrated hands‑on experience with nonconformance investigations, root cause analysis, and CAPA execution.
• Working knowledge of ISO 13485, FDA 21 CFR Part 820, and risk‑based quality system
• Practical understanding of validation concepts, inspection methods, and statistical analysis.
• Strong written and verbal communication skills with the ability to work effectively in cross‑functional teams.

• Experience supporting risk management activities per ISO 14971.
• Experience supporting validation, verification, and/or design transfer activities.
• Experience participating in internal or external audits and inspection readiness activities.
• Lean Six Sigma Yellow Belt or higher.
• Experience with sterile medical devices and/or ethylene oxide (EO) sterilization.

• The job is performed indoors in a variety of settings including office, manufacturing floor and warehouse with no abnormal hazards or risks. Protective safety clothing may occasionally be required including appropriate dress code: no makeup or jewelry, shoe coverings, gloves, hair net, and lab coat as needed.
• Work may require weekend and evening work.
• Visual ability to make visual inspection decisions.
• Work under stress in a fast‑paced environment.
• Must be alert, able to concentrate, and use good judgment.
• Must be able to work under conditions that require sitting, standing, walking