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. Benefits:
Our Benefits Include:
Medical, Dental, and Vision Insurance 401(k) Retirement Plan Health Savings Account (HSA) Disability Insurance (Short-Term and Long-Term) Life and AD&D Insurance Paid Sick Leave (where required by applicable state or local law) Supplemental Insurance Plans Identity Theft Protection Pet Insurance Employee Wellness Programs Employee Assistance Program (EAP) Career Growth and Professional Development Opportunities

Disclaimer: Benefits eligibility, accrual rates, and usage limits may vary based on employment status, length of service, and work location. Paid Sick Leave is provided in strict accordance with applicable state and municipal mandates. Cynet Systems Inc. reserves the right to modify,…