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
Full time, Contract work,