Quality Engineer

SUMMARY

Join a quality-focused medical manufacturing environment where you will play a key role in maintaining and improving product quality, regulatory compliance, and quality system effectiveness. This position offers the opportunity to work cross-functionally with engineering, operations, suppliers, and leadership while supporting new product development and continuous improvement initiatives. The Quality Engineer serves as a subject matter expert for quality processes, supplier quality, and regulatory compliance.

RESPONSIBILITIES

• Support, maintain, and improve the Quality Management System (QMS) in compliance with FDA, ISO 13485, MDSAP, and other applicable regulatory standards.
• Develop, review, and maintain quality documentation including SOPs, protocols, reports, validation documents, quality plans, and work instructions.
• Investigate product, process, and supplier-related quality issues and implement effective corrective actions.
• Coordinate nonconformance activities, Material Review Board (MRB) processes, and CAPA investigations within an electronic quality management system.
• Analyze quality metrics and trend data to identify risks, improvement opportunities, and compliance concerns.
• Lead root cause investigations related to complaints, audits, product issues, and manufacturing deviations.
• Manage complaint records and support complaint investigations, including regulatory reporting assessments when required.
• Oversee calibration activities to ensure inspection and production equipment remain compliant and properly maintained.
• Monitor environmental controls and respond to out-of-specification conditions as necessary.
• Support supplier quality activities including supplier documentation, evaluations, and audits.
• Maintain device records, quality documentation, and change control processes.
• Process engineering and document change requests while ensuring proper implementation and compliance.
• Develop clear process instructions and support employee training initiatives.
• Partner with cross-functional teams to support product development, manufacturing quality, and continuous improvement efforts.

QUALIFICATIONS

• Associate degree in a technical discipline required; Bachelor’s degree preferred.
• 5–7 years of experience within a medical device or regulated manufacturing environment preferred.
• 3–5 years of experience authoring technical documentation compliant with FDA and ISO 13485 requirements.
• Strong understanding of quality systems, regulatory compliance, risk management, validation, statistical analysis, FMEA, and reliability principles.
• Experience managing nonconformances, CAPAs, complaint investigations, and root cause analysis.
• Knowledge of FDA Quality System Regulations, ISO 13485, and related medical device standards.
• Experience with supplier quality programs and audit support is highly desirable.
• Strong technical writing, communication, and organizational skills.
• Proficiency with electronic document management and quality management systems.
• Ability to manage multiple priorities independently in a fast-paced environment.
• ASQ certification and experience with quality management software platforms are a plus.
• Approximately 10% travel may be required.

BENEFITS

• Opportunity to make a direct impact on product quality and patient safety.
• Exposure to new product development and regulatory compliance initiatives.
• Collaborative environment with cross-functional interaction and leadership visibility.
• Professional growth within quality engineering, supplier quality, and regulatory compliance disciplines.
• Opportunity to work with advanced quality systems, investigations, validation activities, and continuous improvement programs.
• Comprehensive benefits package, paid time off, and career development opportunities (where applicable).