Quality Engineer II

3 weeks ago

Newport Beach, United States Renata Medical Full time

Quality Engineer II Renata Medical Newport Beach, CA From $78,000 a year Full-time

Position Overview Renata Medical is seeking an experienced quality engineer to develop critical functions for commercial pediatric cardiovascular medical devices. The role involves managing a diverse range of responsibilities related to implementation and maintenance of the quality management system. This candidate will report directly to the Director of Quality and will play a pivotal role in developing new devices in the pediatric cardiology space and ensure the safety and efficacy of those devices. Renata is a fast-paced startup company that will rely on a motivated candidate able to work with a small team, embrace new challenges, and develop a strong quality system to support development and commercial goals.

Quality Activities Responsible for developing test methods and documenting protocols/reports to verify and validate device design, process, sterilization, shelf-life, biocompatibility, distribution, and others. Responsible for investigating CAPAs, SCARs, Product Complaints, Non-Conforming Material Reports, RGA’s and other QA processes and identifying and implementing effective corrective and preventive actions. Performs trend analysis and establishes corrective/preventive actions as required. Responsible for set-up and validation of test methods, procedures and sampling plans for inspection and testing of finished products. Responsible for conducting hazard analysis and ensuring design and process FMEAs are conducted per ISO 14971. Responsible for initiation and approval of change orders (COs) with proper documentation of change, reasons and justifications. Responsible for monitoring supplier quality. Assists in supplier audits to ensure continued compliance and acceptability. Performs statistical analysis of product testing data. Performs robust root cause and corrective action analysis. Performs internal audits per the audit plan and implement/assist in implementing corrective and preventive actions. Recommends improvements in quality system to ensure that the quality system is efficient and effective controls are in place to minimize risk. Follows and enforces compliance to the Company’s quality system and regulatory body requirements per ISO 13485/FDA’s QSRs. Responsible for providing support to achieve quality objectives. Completes projects in a timely manner and consistent with corporate objectives. Identifies needs and document SOPs, test methods, protocols, reports, DCOs, etc. Interfaces with suppliers, contract manufacturers, contract developers. Ensures proper documentation of Design History Files per the company’s procedures.

Position Requirements Prior experience in the medical device field Proficient in use of MS Word, Excel, and PowerPoint Ability to read and understand industry standards and regulations Ability to perform basic statistics and willingness to learn more advanced statistical methods

Education Requirements Bachelor’s degree for engineering or comparable experience

Experience Requirements 2+ years quality engineering/assurance experience with medical devices High level of organizational skills Basic statistical skills

Benefits Health insurance Dental insurance Paid time off Stock options Bonus pay

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