13766 Alton Parkway, Suite 150,
Irvine, CA 92618
Director of Quality Assurance
General Job Description:
The Director of Quality Assurance will be an integral part of an expanding quality team that is responsible for implementing, maintaining and documenting our quality systems. You will be expected to lead a cross discipline team supporting the quality systems.Work can include but is not limited to creating and maintaining design history files; supporting regulatory affairs for new product development; monitoring, and supporting quality systems for manufacturing and new product development; support Fluxergy in obtaining ISO 13485:2016.
Minimum 5 years QA management, experience in medical devices
Class I and II medical device experience
Experience in all aspects of Regulatory Affairs (510(k), IDE, establishment registration, CDPH manufacturer licensing, CE marking, Canadian medical device licensing, other international filings, etc.)
Experience in all aspects of Quality Assurance (QSR, ISO 13485, CMDR, auditing, complaint handling, eMDR/MPR/vigilance, ISO assessments, FDA inspections, design controls, risk management, sterilization validation, process and production validation, etc.)
Must have previous experience interacting with FDA and other regulatory agencies
Specifically, you can be expected to complete the following tasks:
Participate in Regulatory Affairs activities for all current and future medical device products
Responsible for supporting submission of 510(k)s, preparation and maintenance of Technical Files and submission of any other documentation required for other OUS markets
Act as liaison with the FDA, CDPH, notified body and other regulatory authorities, as well as distributors
Ensure continued establishment registration with FDA and manufacturing licenses with CDPH
Provide management and leadership to the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes.
Represent quality management on project team and management review meetings.
Review and approve design, development and operations change orders and software change orders.
Ensure compliance to design control regulations during product development and delivery activities.
Responsible for keeping management team informed of regulatory status of products and significant regulatory issues.
Provide counsel, training, and interpretation of regulatory requirements to Company personnel and assist as a liaison between the Company and regulatory bodies.
Responsible for the development, supervision, overall direction and management of Quality Assurance, Quality Control and Document Control
Supporting the creation and maintenance of control charts in production by working with production engineering team.
Supporting creation and maintenance on design history files by working with product development team.
Support QA and QC in developing and executing compliance activities and corrective actions involving regulatory authorities.
Support in the creation and monitoring of company wide digital QMS system and database.
Must be highly detail oriented and have strong organizational ability
Ability to interpret regulations, standards and guidance’s, procedure relevant procedures and implement requirements
Must have excellent written and verbal communication skills
Statistical Technique knowledge and Gage R&R is a plus
Bachelor’s degree in Life Sciences or Engineering
Documented auditor training
ASQ certification a plus
Application Information & Contact (How to Apply)
To apply, please answer the following questions and visit the job link here
What ISO quality systems are you familiar with?
Have you supported in the submission of a FDA approved medical device? If so what class medical device?
In what capacity have you worked on electronic quality management systems?
Learn more about Fluxergy here