Senior Quality Systems Engineer

About the role

The Sr. Quality Systems Engineer plays a crucial role in the Quality Systems & Compliance team at RxSight®, focusing on the Nonconforming Material Report (NCMR) and Material Review Board (MRB) program. This position involves coordinating investigations, dispositions, and closure activities across various departments, ensuring product quality, regulatory compliance, and document control.

Responsibilities

• Review and manage MRB/NCMR activities, moving items electronically and physically as required.
• Cook up coordination with cross-functional teams, including Manufacturing, Engineering, Supply Chain, and Regulatory Affairs, regarding investigations, dispositions, and implementation activities.
• Review nonconformance records for completeness, accuracy, and compliance, and support users with quality system questions and troubleshooting.
• Track, report, and trend nonconformance metrics, reviewing aging/open NCMRs and escalating as necessary.
• Schedule and host MRB meetings, generate and review quality metrics/KPIs, and review trends related to nonconformances, supplier issues, and product lines.
• Support the update, validation, and verification of electronic systems.
• Lead and implement automations within existing systems to streamline workflows.
• Support updates to procedures, forms, and work instructions, and other QMS-related activities as needed.
• Support internal and external audits, review process effectiveness, and assist with implementation or validation activities related to quality systems and processes.
• Support Management Review and Post-Market Surveillance reporting, external audit preparation, and periodic review/update of controlled documents and quality records.
• Support continuous improvement initiatives and system enhancements across the quality organization.

Requirements

• Strong working knowledge of nonconforming material control, MRB disposition processes, and root cause investigation.
• Proficiency in Microsoft Word, Excel, Smartsheet, Power BI, and other quality management software systems.
• Working knowledge of ISO 13485, 21 CFR 820, 21 CFR Part 11 as they relate to nonconformance handling.
• Basic knowledge of quality system and device requirements in the US, EU, Mexico, Canada, Australia, Brazil, Japan, and other markets.
• A curious mindset with a strong sense of integrity, accountability, and commitment to service.
• A detail-oriented individual capable of evaluating engineering justifications, product impact analyses, and risk assessments supporting MRB dispositions.
• Excellent interpersonal, computer, communication, and presentation skills.
• A self-starter able to succeed in an unstructured environment.
• Proven ability to collaborate across Manufacturing, Engineering, Supply Chain, and Regulatory Affairs, and to influence MRB stakeholders without formal authority.

Qualifications

• Minimum of Bachelor's Degree and 3+ years of relevant quality engineering/nonconformance experience, or equivalent combination of education and experience.
• Experience with an electronic nonconformance/MRB system (Grand Avenue Software or equivalent) and QAD (ERP) a plus.
• Proficient with Microsoft office tools.
• Good decision-making, organization skills, problem-solving skills, and teamwork oriented.

Skills

• ASQ certification or CQE recommended but not required.
• Computer skills within spreadsheets, documents, electronic systems.

Pay

$105,000 To $120,000 Per Year