Quality Engineer

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

Essential Functions:

• 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 relative issues to ensure product and service with high quality, meet or exceed customer requirements.
• Promptly handle customer feedback & complaints (includes but not limited to receiving, evaluation handling, response and trend analysis), and lead the analysis and resolution of internal customer complaint. When necessary, provide investigation results to HQ P ost-market team within 24 hours
• Technical support of Physical Products including problem solving & instruction for use .
• Tracking new products/projects after sales; post-market problem identification and internal improvement motivation; post-market data collection and analysis;
  Promote the actions taken related to customer complaints.
• Collaborate with HQ team to conduct FCA (field corrective action).
• Manage and audit Class B suppliers (e.g., packaging materials); support HQ SQE teams in the management of Class A suppliers (key raw materials).
• Develop inspection and control documents for product quality and provide job training and assessments for relevant employees.
• Assist in implementing & maintenance quality management system and support audits, track improvement measures, actively use various quality improvement tools, and promote them extensively to facilitate improvements in quality control.
• Track changes in various aspects’ validation of the production line (new raw materials, new processes, new equipment) and ensure the continuous stability of products.
• Track Non-Conformance Reports (NCR), Corrective and Preventive Actions (CAPA), and other anomalies.
• Strictly adhere to company’s relative regulations of information security and privacy.
• Supports nonconformance investigations, including containment, defect analysis, and documentation.
• Other duties as assigned.

Qualifications:

• 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 but not required

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.
• 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

Physical and Work Environment Requirements:

• Ability to work in office, lab, and manufacturing environments
• Occasional travel for supplier audits or training
• Ability to lift up to 40 lbs.
• Travel is approximately 10% with overnight stays required
• We offer a competitive base salary and benefits.