Quality Engineer

The Quality Engineer is responsible for supporting and maintaining the Quality Management System (QMS) within a regulated medical device manufacturing environment. This role leads and supports validation activities, internal audits, nonconformance investigations, environmental monitoring review, and risk management activities. The Quality Engineer partners closely with Engineering, Manufacturing, and Quality teams to ensure compliance, drive continuous improvement, and support successful product development and transfer to production.

Performance is evaluated based on quality of work, timeliness, productivity, adherence to procedures, regulatory compliance, safety performance, and contribution to continuous improvement initiatives.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES

Safety & Compliance

• Promote and maintain a strong safety culture, ensuring adherence to all site safety policies and procedures
• Comply with applicable regulatory requirements including FDA QSR, ISO 13485, ISO 14971, OSHA, EPA, and internal quality system requirements
• Maintain compliance with Good Manufacturing Practices (cGMP) and ensure regulatory readiness in all assigned activities

 

Quality Systems & Regulatory Compliance

• Support maintenance and continuous improvement of the Quality Management System (QMS)
• Ensure timely and compliant execution of quality system processes and documentation control
• Evaluate compliance trends and recommend improvements to strengthen system effectiveness

 

Validation & Process Development Support

• Develop, review, and approve validation protocols and final reports (IQ/OQ/PQ as applicable)
• Review experimental and process development documentation for completeness and compliance
• Support transfer of new products from development into manufacturing, ensuring alignment with specifications and quality requirements
• Participate in process improvement and validation lifecycle activities

 

 

Nonconformance, CAPA & Disposition Activities

• Review and approve nonconformance investigations and material dispositions (MRB activities)
• Approve rework plans and ensure compliance with defined quality requirements
• Support root cause analysis and corrective/preventive action (CAPA) investigations
• Review defect threshold investigations and associated data analysis
• Ensure timely closure and effectiveness verification of assigned CAPAs

 

Risk Management (PFMEA)

• Develop, maintain, and update Process Failure Mode and Effects Analyses (PFMEAs)
• Collaborate with Engineering and Manufacturing to identify risks and implement mitigation strategies
• Ensure risk management documentation aligns with ISO 14971 principles and product lifecycle requirements

 

Internal Auditing & Quality Monitoring

• Plan, conduct, and document internal audits across manufacturing and support functions
• Track audit findings and ensure timely closure of corrective actions
• Generate audit reports and support regulatory and customer audits as needed
• Review environmental monitoring data and investigate excursions beyond established limits

 

Customer & Manufacturing Support

• Assist with customer complaint investigations and technical response activities
• Partner with Manufacturing and Engineering to resolve quality issues and improve process capability
• Support daily production activities through participation in meetings and real-time issue resolution

 

Training & Continuous Improvement

• Support employee training related to quality systems and compliance requirements
• Participate in continuous improvement initiatives and cross-functional projects
• Lead or support assigned quality and operational improvement projects

 

 

 

 

Documentation & Reporting

• Create and maintain controlled quality system documentation, including valid