Quality Engineer

About the Role

The Quality Engineer ensures compliance of products and processes with the FDA QMSR 820 and ISO 13485 through performing inspections, conducting tests, analyzing data, and providing support for manufacturing operations and quality functions. This role bridges hands-on technical execution and engineering-level solutions to uphold product quality, process control, and audit compliance.

Responsibilities

• Performs incoming, in-process, and final inspections using calipers, micrometers, gauges, vision systems, or other metrology tools.
• Responsible for daily product quality management on the production line, promptly addressing issues to ensure high-quality products and services that meet or exceed customer requirements.
• Handles customer feedback and complaints, including receiving, evaluation, response, and trend analysis. Leads the analysis and resolution of internal customer complaints and provides investigation results to HQ Post-market team within 24 hours when necessary.
• Provides technical support for physical products, including problem-solving and instruction for use.
• Tracks new products/projects after sales; identifies post-market problems and drives internal improvements; collects and analyzes post-market data; promotes actions related to customer complaints.
• Collaborates with HQ team to conduct Field Corrective Actions (FCA).
• Manages and audits Class B suppliers (e.g., packaging materials); supports HQ SQE teams in managing Class A suppliers (key raw materials).
• Develops inspection and control documents for product quality and provides job training and assessments for relevant employees.
• Assists in implementing and maintaining the quality management system, supports audits, tracks improvement measures, and actively uses quality improvement tools to facilitate improvements in quality control.
• Tracks changes in production line validations (new raw materials, processes, equipment) and ensures continuous product stability.
• Tracks Non-Conformance Reports (NCR), Corrective and Preventive Actions (CAPA), and other anomalies.
• Strictly adheres to company regulations regarding information security and privacy.
• Supports nonconformance investigations, including containment, defect analysis, and documentation.
• Performs other duties as assigned.

Requirements

• Associate or Bachelor’s degree in Engineering, Quality, or related technical field (or equivalent experience).
• Experience in a regulated manufacturing environment—medical device preferred.
• Strong understanding of cGMP, ISO 13485, and QMSR 820.
• Proficiency with measurement tools and inspection equipment.
• Strong documentation, communication, and analytical skills.

Preferred Qualifications

• Experience with CAPA, NCRs, and root-cause analysis tools.
• Familiarity with statistical techniques (SPC, MSA, capability studies, sampling plans).
• Experience with cleanroom manufacturing or sterile device processes.

Skills

• Strong problem-solving and critical-thinking skills.
• High attention to detail and documentation accuracy.
• Ability to work cross-functionally in a fast-paced environment.
• Commitment to patient safety and product quality.
• Continuous improvement mindset.

Work Environment

• Ability to work in office, lab, and manufacturing environments.
• Occasional travel for supplier audits or training.
• Ability to lift up to 40 lbs.

Travel & Benefits

Travel is approximately 5% with international overnight stays required.

We offer a competitive base salary and benefits.