Helix is hiring a

Quality System and Compliance Manager / Senior Manager

San Carlos, United States

Helix is seeking a motivated and experienced Quality Systems Manager to join our team.  This position will be part of the Helix Regulatory and Quality Affairs department. This individual will have the opportunity to implement quality processes and work closely with our software development teams in San Carlos and our clinical laboratory in San Diego.

As a Quality Management System Manager, you would be the second member of Helix’s Regulatory and Quality Affairs team. You would have an integral role in FDA Quality Management Systems at our head office and our clinical laboratory. This position provides a unique opportunity to make an immediate impact, and lay the foundation for processes and procedures in a fast-paced dynamic environment. If you are looking for the opportunity to lead and make a significant contribution, this role provides an empowering and action-oriented environment to take your career and our mission to the next level.

If you are interested in applying your compliance knowledge to a company that is poised to bring cutting-edge technology and novel products to the market, join our team. This position will be located at our headquarters in San Carlos (SF Bay Area) with travel to our clinical genetics laboratory based in San Diego.

Everyone can benefit from a better understanding of the most fundamental aspect of what makes them unique: their own DNA. Inside all those A’s, T’s, C’s and G’s lie insights into every person—you just have to know what you’re looking for.  With the backing from the market leader in DNA sequencing Illumina, Helix is creating the world’s first platform for consumers to get sequenced and gain these insights in their DNA through an ecosystem of high quality partners. From personalized medicine to advanced cancer screenings to custom diet and nutrition plans, the world of DNA learning is becoming accessible and more valuable than ever. And as our partners grow, so will the opportunity for discovery.

Responsibilities

Directly responsible for ongoing execution and improvements to the following quality system activities:

  • Responsible for implementing applicable 21 CFR 820 regulations such as Document Control, Internal Audits, Management Review, Purchasing controls, Design Controls etc
  • Stays current with regulatory changes through industry publications, seminars, participation in trade organizations, and government meetings.
  • Identifies and manages continuous improvement projects with the objective of achieving quality and efficiency in processes
  • Works cross-functionally and has the ability to interpret the requirements as well as educate and influence others on those requirements
  • Establish regular employee training in QSR and ISO regulations.

Requirements

  • 5 to 8 years Quality Management System Manager (2-3 years of supervisory experience preferred but not must)
  • Good understanding of medical device regulations (specifically 21 CFR 820)
  • Experience establishing and maintaining a quality management system
  • Supervisory or project management skills and strong quality knowledge and experience
  • Certified Quality Auditor (preferred but not a must)
  • Previous complaint and vigilance reporting experience
  • Strong analytical and problem solving skills
  • Ability to manage/supervise teams / employees
  • Strong communication and leadership skills 
  • Strong written and oral communication skills
  • Ability work effectively and collaboratively in a cross-functional team within a fast-paced environment
  • Able to deliver quality outputs under minimal supervision
  • Willing to travel often between San Carlos and San Diego offices 

Education

  •   Bachelor’s degree in Science or related technical field required