Job Description

Sr. Quality Engineer

Renata Medical

Newport Beach, CA

From $95,000

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

o Prior experience in the medical device field

o Proficient in use of MS Word, Excel, and PowerPoint

o Ability to read and understand industry standards and regulations

o Ability to perform basic statistics and willingness to learn more advanced statistical methods

Education Requirements

o Bachelor’s degree for engineering or comparable experience

Experience Requirements

o 2+ years quality engineering/assurance experience with medical devices

o High level of organizational skills

o Basic statistical skills

Benefits

o Health insurance

o Dental insurance

o Paid time off

o Stock options

Supplemental Pay

o Bonus pay 

Job Tags

Similar Jobs