IRIDEX Corporation is a medical device manufacturer and operates in a global regulated environment (e.g. FDA). Regulations include (but are not limited to) FDA 21 CFR 820, EN ISO 13485, and the European Medical Device Regulation (MDR). Based on the position, experience in a regulated environment and the extent of working knowledge of appropriate regulations may vary. 

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 assist with the identification and resolution of product and process quality issues. Responsibilities include supporting root cause investigations, tracking corrective actions, evaluating nonconforming materials, and helping maintain compliance with FDA and ISO 13485 requirements. The position offers hands-on experience in a regulated manufacturing environment with exposure to electromechanical and software-integrated medical devices.

MAJOR DUTIES AND RESPONSIBILITIES:

• Support investigations for product quality issues across mechanical, electrical, and software components.
• Assist in root cause analysis and contribute to Corrective and Preventive Action (CAPA) activities.
• Manage the Nonconforming Material (NC) process end-to-end—from identification and evaluation to coordination of the Material Review Board (MRB) for timely and effective disposition of nonconforming product.
• Assist in supplier quality management activities, including performance monitoring, documentation maintenance, and follow-up on Supplier Corrective Actions (SCARs) to ensure root cause resolution and sustainable improvements.
• Collaborate with Manufacturing and Engineering teams to evaluate process improvements and product quality concerns.
• Support incoming inspection process, verification of components, and evaluation of test data.
• Review Engineering Change Orders (ECOs) for quality impact under supervision.
• Contribute to risk management documentation (e.g., FMEA) as part of design and process evaluations.
• Assist in managing the calibration program for measurement equipment and support investigations of out-of-tolerance (OOT) tools.
• Assist in the documentation of complaint investigations and return analysis reports.
• Participate in internal audits, supplier evaluations, and quality improvement projects.
• Maintain detailed records, forms, and reports in accordance with QMS and regulatory requirements.

JOB SKILLS:

• Solid understanding of quality engineering principles (e.g., CAPA, NCRs, risk analysis).
• Familiarity with FDA 21 CFR 820, ISO 13485, and ISO 14971 requirements.
• Familiarity with medical device standards such as IEC 60601 is advantageous.
• Ability to read and interpret engineering drawings and specifications.
• Working knowledge of basic inspection tools and techniques.
• Strong analytical and problem-solving skills, including root cause analysis techniques.
• Effective communication skills and ability to work in cross-functional teams.
• Attention to detail, organizational skills, and the ability to manage multiple priorities.
• Detail-oriented with a commitment to quality and continuous learning.
• Basic understanding of statistical analysis and sampling methods is a plus.

QUALIFICATIONS:

• Bachelor’s degree in Biomedical, Mechanical, Industrial, or related engineering field.
• 2 to 5 years of experience in a Quality or Manufacturing Engineering role, preferably in a medical device or regulated industry.
• Experience with CAPA, and nonconformance systems preferred.
• Working knowledge of risk management tools (FMEA) and quality planning.
• Certification such as ASQ Certified Quality Engineer (CQE) is a plus.
• Advanced problem-solving skills including troubleshooting and root cause analysis
• Familiarity with sterilization validation, environmental monitoring, and cleanroom protocols is desirable.
• Effective written and verbal communication skills in English.
• Basic knowledge and understanding of Quality Management System regulations including but not limited to ISO 13485 and 21CFR820. 

 ADDITIONAL INFORMATION:

• Department: QA
• Reports To: Sr. Manager, Quality Assurance
• FLSA Status: Exempt
• Base Salary: $80,000 - $118,000 DoE
• Travel: 10%
• Work Location: This job will be primarily onsite; the percentage of supplier-visit work will be defined by the management