Quality Engineer II

Job Responsibilities

• 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 compliance with FDA, ISO 13485, GMP, and internal quality requirements.
• Investigate product and process nonconformances and perform root cause analysis using structured problem-solving 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 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 opportunities for improvement.
• 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 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.

Technical Skills

• Demonstrated hands-on experience executing and documenting IQ, OQ, PQ, and TMV activities.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and medical device quality system requirements.
• Experience conducting & documenting root cause investigations and implementing effective CAPAs.
• Working knowledge of NCR, CAPA, change control, deviation, and risk management processes.
• Experience with validation lifecycle management, 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 problem-solving methodologies.
• Proficiency in reviewing technical drawings, specifications, procedures, and validation documentation.

Professional Skills

• Strong technical writing and documentation skills.
• Excellent verbal and written communication abilities.
• Ability to work effectively with Manufacturing, Engineering, Regulatory Affairs, Operations, and Quality teams.
• Strong organizational skills with the ability to manage multiple priorities and projects.
• Detail-oriented with a commitment to compliance and product quality.
• Self-motivated and capable of independently managing projects, investigations, validations, and quality system activities while also contributing effectively in a team-oriented environment.
• Proven ability to build strong working relationships across Manufacturing, Engineering, Quality, Regulatory, and Operations functions to achieve shared objectives.

Education/Experience

• Bachelor's degree in engineering required.
• 2-4 years experience required.