Quality Engineer II

Found in: Appcast Linkedin GBL C2 - 2 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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