Quality Engineer

PURPOSE OF JOB:

The Quality Assurance (QA) department is committed to ensuring that all products are safe, reliable, and effective, consistently exceeding the expectations of patients, physicians, and healthcare providers. QA plays a critical role in maintaining product and process quality throughout the commercial production of Iridex’s portfolio, including laser consoles, delivery devices, and accessories.

In this role, the Quality Engineer will lead and support quality engineering activities associated with product quality, manufacturing processes, supplier quality, and regulatory compliance. Responsibilities include leading root cause investigations, driving CAPA activities, evaluating nonconforming materials, supporting risk management activities, and ensuring compliance with FDA and ISO 13485 requirements. This position works cross-functionally with Manufacturing, Engineering, Regulatory Affairs, and suppliers to support continuous improvement initiatives, manufacturing transfers, and process validations in a regulated medical device environment.

MAJOR DUTIES AND RESPONSIBILITIES:

•  Lead investigations for product and process quality issues across mechanical, electrical, optical, and software-integrated systems.
• Lead root cause investigations and drive Corrective and Preventive Action (CAPA) activities to effective closure.
• Manage the Nonconforming Material (NC) process end-to-end, including Material Review Board (MRB) activities and disposition decisions.
• Partner with Manufacturing and Engineering teams to evaluate process improvements, manufacturing transfers, and product quality concerns.
• Lead and support risk management activities including Design FMEA, Process FMEA (PFMEA), and risk assessments in accordance with ISO 14971 requirements.
• Support development, review, and execution of process validation activities including IQ/OQ/PQ protocols and reports.
• Review and approve Engineering Change Orders (ECOs) for quality and regulatory impact.
• Support supplier quality management activities including supplier evaluations, audits, SCARs, and supplier performance monitoring.
• Analyze quality data, trends, and metrics to identify opportunities for process improvement and risk reduction.
• Support incoming inspection activities, evaluation of inspection/test data, and disposition of nonconforming materials.
• Support complaint investigations, failure analysis, and returned product evaluations.
• Participate in internal audits, supplier audits, and external regulatory inspections.
• Support calibration program activities and investigations related to out-of-tolerance (OOT) measurement equipment.
• Ensure quality records, reports, and documentation are maintained in accordance with applicable QMS and regulatory requirements.
• Provide guidance and technical support to junior quality personnel and cross-functional teams as needed.

JOB SKILLS:

• Strong understanding of quality engineering principles including CAPA, NCR, SCAR, risk management, and statistical analysis. 
• Strong working knowledge of FDA 21 CFR 820, ISO 13485, MDSAP, MDR and ISO 14971, and applicable medical device regulations.
• Experience leading risk management activities including FMEA facilitation and risk assessments.
•  Familiarity with medical electrical device standards such as IEC 60601 is preferred.
• Ability to read and interpret engineering drawings, schematics, and specifications.
• Experience with manufacturing process validation methodologies (IQ/OQ/PQ).
• Strong analytical, troubleshooting, and root cause investigation skills.
• Experience working in cross-functional teams within regulated manufacturing environments.
• Effective communication, technical writing, and organizational skills.
• Experience using quality systems and PLM/ERP systems is preferred.
  
  

QUALIFICATIONS:

• Bachelor’s degree in biomedical, Mechanical, Electrical, Industrial, or related engineering field.
• 4 to 7 years of Quality Engineering experience in a medical device or other regulated manufacturing environment. 
• Strong experience with CAPA, nonconformance management, root cause investigations, and supplier quality systems.
• Experience leading or facilitating FMEA activities including Design FMEA and PFMEA.
• Experience supporting manufacturing transfers, process validations, and risk management activities preferred.
• Working knowledge of FDA Quality System Regulation (21 CFR 820), ISO 13485, MDSAP, MDR and ISO 14971 requirements.
• ASQ Certified Quality Engineer (CQE) or equivalent certification is preferred.
• Strong problem-solving, technical writing, and project coordination skills.
• Familiarity with sterilization validation, environmental monitoring, and cleanroom controls is desirable.
• Effective written and verbal communication skills in English.

ADDITIONAL INFORMATION:
Base Salary: $112,000 - $120,000
Travel: 10%
Work Location: This job will be primarily onsite; the percentage of vendors who visit work will be defined by the management.