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 validation records and risk assessments
• Generate and track special handling documentation and quality records as required
• Maintain accurate and complete records in compliance with regulatory requirements

SUPERVISORY RESPONSIBILITIES

• None

QUALIFICATIONS REQUIREMENTS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made.

Education & Experience

• High school diploma or GED required
• Associate or Bachelor's degree in Engineering, Science, or related technical field preferred
• 5–7 years of experience in medical device manufacturing or regulated manufacturing environment required
• Strong knowledge of cGMP and ISO 13485 requirements required
• Working knowledge of ISO 14971 risk management principles required

Technical Skills

• Proficient in Microsoft Office (Word, Excel, PowerPoint, Project)
• Experience with statistical tools and data analysis techniques preferred
• Familiarity with ERP and quality systems preferred
• Strong technical writing and documentation skills

Communication Skills

• Strong verbal and written communication skills across all organizational levels
• Ability to present technical information clearly and effectively
• Ability to facilitate cross-functional discussions and training sessions
• Strong collaboration skills with Engineering, Manufacturing, and Quality teams

Mathematical & Analytical Skills

• Ability to work with basic mathematical concepts including addition, subtraction, multiplication, division, fractions, and decimals
• Ability to analyze data trends using spreadsheets and statistical tools
• Ability to interpret quality data and identify process variation

Reasoning Ability

• Ability to apply logical thinking to solve problems and interpret technical instructions
• Ability to make sound, data-driven decisions in a regulated environment
• Ability to manage multiple priorities and independently execute tasks

PHYSICAL DEMANDS

• Must be able to analyze data in multiple formats and systems
• Must be able to make independent decisions related to quality and compliance
• May be required to lift and/or move up to 50 pounds
• Ability to work in both office and controlled manufacturing environments

WORK ENVIRONMENT

• Primarily office-based with periodic exposure to manufacturing environments
• Manufacturing areas may require PPE such as hairnets, smocks, gloves, and safety glasses
• Exposure to controlled environments and low-level chemical or solvent odors may occur
• Work environment is generally well-lit and temperature controlled