Associate Quality Engineer - ZipRecruiter : Job Details

Job DescriptionJob DescriptionDescription:

RxSight is an ophthalmic medical technology corporation headquartered in Aliso Viejo, California that has commercialized the world's first and only adjustable intraocular lens (IOL) that is customized after cataract surgery. The company's mission is to revolutionize the premium cataract surgery experience by allowing surgeons to partner with their patients to achieve optimized results for every unique eye.

OVERVIEW:

The Associate Quality Engineer position requires significant learning agility and adaptability to successfully operate in a highly dynamic and innovative environment. The Associate Quality Engineer will be responsible for ensuring product safety by supporting the complaint handling process. Responsibilities will include managing the intake process, leading and documenting investigations and failure analysis as required and ensuring information flows back into the design and development and risk management processes. The Associate Quality Engineer will support all RxSight products and will be expected to apply knowledge of process engineering, risk management, and quality engineering techniques to innovate and improve quality system processes while simultaneously ensuring conformance to applicable regulatory requirements.

In addition, the Associate Quality Engineer will set up and manage Good Manufacturing Practices in support of production and implement and maintain policies and procedures to ensure compliance with Quality System Regulations (QSR's) for medical devices. The Associate Quality Engineer will be responsible for establishing documentation control and approval workflows to support manufacturing and testing for processes, test methods, test results, batch records, etc. for manufacturing and collaborate with Product Development, Manufacturing, and other cross-functional teams to ensure product quality and regulatory compliance.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Investigate or facilitate the investigation activities for product complaints
• Monitor post-market data for trends
• Manage the complaint intake process
• Manage the decontamination and disposition of returned materials
• Review device history records, test results and release material for use
• Establish and maintain material control practices for the production area
• Control materials for use in manufacturing and non-conforming materials
• Perform corrective actions and root cause analysis as required
• Create, review, and maintain risk management files within functional area
• Perform audits of manufacturing practices to confirm operations to established processes
• Establish and maintain document control practices for the manufacturing area including batch records, data systems, and material release
• Initiate change requests and approve change requests
• Review data, lab notebooks, and release documentation as required
• Lead the review of all material review board dispositions within functional area
• Maintain and update equipment development, validation, and installation process
• Maintain compliance with the latest standards as required
• Support audits as necessary with information from the manufacturing and development areas
• Ensure compliance with the company's product development standards for new product development

Requirements:

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:

• Knowledgeable of 21 CFR 820, 21 CFR 807, 21 CFR 806, and 21 CFR Part 11
• Knowledgeable of ISO 13485 and 14971
• Knowledgeable of requirements for medical devices in US, EU, Mexico, Canada, Australia, Brazil, South Korea, Singapore, Japan, and other markets
• Able to perform product failure analysis
• Able to perform basic statistical analysis
• Strong interpersonal skills, well-established computer, communication, and presentation skills
• Able to manage complaint, CAPA, training, non-conformances, change control, engineering change requests, and other quality systems
• Knowledgeable of IEC 60601-1

SUPERVISORY RESPONSIBILITIES:

• None

EDUCATION, EXPERIENCE, and TRAINING:

• BS degree in an engineering or science discipline or combined education and experience.
• 1 year of experience performing quality assurance/regulatory affairs and developing processes in a manufacturing and/or product development environment preferably in the medical device industry.
• Training to be completed per the training plan for this position as maintained in the document control system
• The training requirements on TRN-10007 Insider Trading Policy, TRN-10008 Global Anti-Bribery and Anti-Corruption Policy and TRN-10009 Code of Business Conducts and Ethics must be diligently completed within 30 days from the hiring date and on an annual basis

CERTIFICATES, LICENSES, REGISTRATIONS:

• ASQ certification (CQE, CSQP) or RAC recommended but not required

COMPUTER SKILLS:

• Competent in use of spreadsheets and documents
• Competent in preparing presentations

Notice to Staffing Agencies and Search Firms:

RxSight does not accept unsolicited resumes or candidate submissions from staffing agencies or search firms for any employment opportunities. All agency engagements must be authorized in writing for a specific position by RxSight's Talent Acquisition department. Any resumes or candidate information submitted without such specific engagement will be considered unsolicited and the property of RxSight. No fees will be paid in the event a candidate is hired under these circumstances.