Quality Assurance Specialist

Job Summary:The Quality Assurance Specialist ensures product quality in a regulated environment, focusing on Aerospace and Medical Device standards. This role is detail-oriented, compliance-driven, and proactive in maintaining quality processes. The specialist oversees the Quality Management System (QMS), leads quality control activities, and ensures proper calibration and instrument control to meet regulatory requirements such as ISO 9001, ISO 13485, AS9100, and FDA standards. The ideal candidate collaborates with cross-functional teams, drives continuous improvement, and maintains high standards of quality and compliance.Duties/Responsibilities:Quality Management System (QMS) Oversight:Maintain QMS compliance with ISO 9001, ISO 13485, AS9100, and FDA regulations.Conduct internal audits to ensure QMS adherence.Develop and enforce SOPs for product complaints and quality processes.Manage Supplier and Customer Quality Agreements.Quality Control:Lead RCCA to resolve non-conformances.Manage NCMR process for documenting and resolving discrepant materials.Oversee RMA process for customer returns.Calibration and Instrument Control:Ensure gauges and measurement equipment are calibrated to industry standards.Maintain calibration compliance, schedules, and documentation.Administer CPAR to mitigate risks.Document QA activities via reports, audits, and problem logs.Train team members on quality systems and procedures.Report quality metrics and KPIs to the Quality Assurance Manager.Support additional tasks as assigned.Required Skills/Abilities:Knowledge of ISO 9001, ISO 13485, AS9100, and FDA regulations.Strong analytical, problem-solving, and decision-making skills.Proficient with inspection tools (micrometers, calipers, gauges).Ability to read blueprints and technical documents (GD&T preferred).Excellent communication and collaboration skills.Highly organized, proactive, and compliance-focused.Education and Experience:Bachelor’s degree in Engineering, Quality Management, or related field (or equivalent).3 years of quality assurance experience in aerospace or medical device industries.Lean Six Sigma experience desirable. ASQ or similar certifications preferred.Physical Requirements:Prolonged periods sitting at a desk and working on a computer.Must be able to lift to 15 pounds at times.In accordance with the Americans with Disabilities Act and any applicable state law prohibiting discrimination on the basis of a physical or mental disability, it is possible that requirements may be modified to reasonably accommodate a disabled individual. However, no accommodations will be made which may pose certain health or safety risks to the employee or others or which impose undue hardships on the Company.

Salary : $55,000 - $70,000