Medical Device QA Manager

Company: Kforce Technology
Location: Carlsbad
Posted on: March 19, 2023

Job Description:

Kforce's client in Carlsbad, CA, a growing and established Medical Device Technology client is seeking a QA Manager. We are working directly with the Hiring Manager on this exclusive search assignment. The company offers a competitive compensation package including base salary, annual bonus and stock/RSU's.

Summary:
The Quality Assurance Manager will be accountable for ensuring the company's medical device products and future products are designed to meet all regulatory compliance requirements. This leader will report to the Director of Quality Assurance, and will be responsible for the implementation, oversight and maintenance of the Design Controls and Product Risk Management processes, including all Sustaining and Quality Engineering activities.

Responsibilities:

• Oversee that the Design History Files in accordance with FDA regulations and standards
  
• Manage a small team of Quality Engineers
  
• Oversee and support the sustaining part of the Product development lifecycle (PLC) in addition to handling product launches
  
• Ensure the Device Master Records are developed and maintain in accordance with FDA regulations including all product process specifications and software specifications, quality assurance procedures, packaging and labeling specifications and installation, maintenance and servicing procedures and methods
  
• Develop and maintain validation and verification processes and procedures
  
• Interface with research and development, manufacturing, quality, outside consultants and vendors to ensure compliance with internal and external policies and procedures, Quality System regulations and FDA/ISO regulations
  
• Maintain supplier qualification, auditing, and surveillance per the QMS
  
• Will be involved with the hardware electronic aspects of the products including the electronic components within the embedded medical devices and base stations
  

Keywords: Kforce Technology, San Diego , Medical Device QA Manager, Executive , Carlsbad, California