Quality Engineer II

Job Responsibilities

Support quality assurance and manufacturing quality activities within a regulated medical device environment.

• Support equipment, process, and test method validation activities, including IQ, OQ, PQ, and TMV.
• Conduct root cause investigations and support nonconformance and CAPA activities.
• Ensure products and processes comply with applicable FDA, ISO 13485, GMP, and internal Quality Management System requirements.
• Support manufacturing, engineering, supplier quality, regulatory, operations, and quality teams in resolving quality issues.
• Analyze quality and manufacturing data to identify trends, recurring defects, and opportunities for improvement.
• Support continuous improvement initiatives focused on process capability, defect reduction, compliance, and operational excellence.

Essential Duties and Job Functions

• Lead and support equipment, process, and test method validation activities, including development, execution, and approval of IQ, OQ, PQ, and TMV protocols and reports.
• Ensure validation activities are performed in accordance with FDA, ISO 13485, GMP, and internal quality requirements.
• Investigate product and process nonconformances and perform root cause analysis using methodologies such as 5 Why, Fishbone, Fault Tree Analysis, and other quality tools.
• Author, review, and maintain NCR, CAPA, deviation, validation, and technical documentation.
• Facilitate CAPA investigations, identify corrective and preventive actions, and verify the effectiveness of implemented solutions.
• Support Manufacturing, Engineering, and Supplier Quality teams in resolving quality issues and reducing recurring defects.
• Participate in risk management activities, including PFMEA reviews, risk assessments, and implementation of risk mitigation strategies.
• Analyze quality and manufacturing data using statistical techniques to identify trends, adverse conditions, and process improvement opportunities.
• Support internal and external audits and regulatory inspections by providing technical documentation and evidence of compliance.
• Review and approve changes through change control processes and assess potential quality impacts to validated systems and processes.
• Develop and revise quality procedures, work instructions, validation plans, and related Quality Management System documentation.
• Drive continuous improvement initiatives focused on process capability, defect reduction, compliance, and operational excellence.
• Provide quality engineering support for new product introductions, manufacturing transfers, and process improvements.

Knowledge & Skills

• Hands-on experience executing and documenting IQ, OQ, PQ, and TMV activities.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, GMP, and medical device quality system requirements.
• Experience conducting and documenting root cause investigations and implementing effective CAPAs.
• Working knowledge of NCR, CAPA, change control, deviation, and risk management processes.
• Understanding of validation lifecycle management, including protocol development, execution, and report generation.
• Working knowledge of statistical analysis tools and quality methodologies, including SPC, Minitab, DOE, Gage R&R, and process capability analysis.
• Experience with PFMEA, risk assessments, and structured problem-solving methodologies.
• Proficiency in reviewing technical drawings, specifications, procedures, and validation documentation.
• Strong technical writing and documentation skills.
• Excellent verbal and written communication skills.
• Strong organizational skills with the ability to manage multiple priorities and projects.
• Detail-oriented with a strong commitment to compliance and product quality.
• Ability to independently manage investigations, validations, projects, and quality system activities.
• Ability to build productive working relationships across Manufacturing, Engineering, Quality, Regulatory Affairs, and Operations.
• Strong teamwork, problem-solving, analytical, and critical-thinking skills.

Education & Experience

• Bachelor's degree in Engineering required.
• 2-4 years of relevant quality engineering experience required.
• Experience in a regulated medical device manufacturing environment preferred.
• Experience with equipment, process, and test method validation preferred.
• Experience with CAPA, NCR, nonconformance investigations, risk management, and change control preferred.
• Familiarity with FDA, ISO 13485, GMP, and Quality Management System requirements preferred.