Senior Quality Engineer

Job Overview:

Pay Range: $37.59hr - $42.59hr

Requirement/Must Have:

• Bachelor's degree in engineering required.
• 2-4 years of experience required.
• 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 and 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.
• Strong technical writing and documentation skills.
• Strong organizational skills with the ability to manage multiple priorities and projects.
• Detail-oriented with a commitment to compliance and product quality.

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.

Skills:

• Installation Qualification (IQ).
• Operational Qualification (OQ).
• Performance Qualification (PQ).
• Test Method Validation (TMV).
• FDA 21 CFR Part 820.
• ISO 13485.
• Quality Management System (QMS).
• Root Cause Analysis.
• CAPA.
• NCR.
• PFMEA.
• Statistical Process Control (SPC).
• Minitab.
• Design of Experiments (DOE).
• Gage R&R.
• Process Capability Analysis.
• Strong verbal and written communication skills.
• Ability to communicate effectively with stakeholders.

Qualification And Education:

• Bachelor's degree in engineering.