This role sits on the Quality Assurance team and will be responsible for the development, implementation, and maintenance of QMS Design Control processes to meet the requirements of U.S. FDA (e.g. 21 CFR Part 820), and other applicable quality and regulatory standards (e.g. ISO 13485, ISO 14971).
As a Design Quality Engineer, you would have an integral role in implementing software medical device lifecycle processes and work closely with the Bioinformatics team to support regulatory submissions and compliance activities. 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.
Continue to advance your career as you:
Be responsible for the creation and maintenance of design history file documents.
Develop risk management plans, verification/validation plans, requirement traceability matrices, and summary reports in collaboration with Bioinformatics team members.
Contribute to the design and process Failure Mode Effects Analysis and System Hazard Analysis activities.
Provide direction on CAPA activities including scope and implementation plans.
Support change control process through the creation of documentation, ensuring adequacy of verification or validation to support the change, good documentation practices and compliance with procedures.
Support internal and external audits and inspections.
We will be looking for you to have:
Bachelor’s Degree in Biomedical, Chemical or other relevant engineering discipline is required.
2 to 7 years of Quality Engineering experience.
Minimum of two (2) years of experience in a design assurance role supporting medical devices that are FDA Class II or Class III.
Working knowledge of FDA Quality System Requirements, ISO 13485, ISO 14971, and IEC 62304.
Working knowledge of Agile Software Development methodologies and associated development tools (Jira, Jama,) is highly desirable.
Track record of creating design history file documents.
ASQ (e.g. CQE, CRE, or CSQE) certifications or other software quality certificates are desirable.
Experience with supporting regulatory audits and FDA inspections is a plus.
It would be even better if you have:
Attention to detail, strong organization skills, and ability to work independently and in teams.
Excellent interpersonal, verbal and written communication skills.
Ability to deliver quality outputs under minimal supervision.
Working knowledge of software configuration management.
Additional Salary Information: What Helix has to offer you
Aside from working alongside brilliant, dedicated, passionate, down-to-earth, curious, warm, and thoughtful people, we also provide great benefits:
Competitive compensation, including meaningful equity
Health insurance, including medical, dental, and vision
12 weeks of Maternity or Paternity leave
4 weeks of paid Pregnancy Disability
401(k) with employer matching
On-premise nursing room
Corporate fitness rate
Founded in 2015, Helix launched the first-ever marketplace for DNA discovery. Our advanced technology and state-of-the-art lab deliver 100x more data than other at-home DNA tests. We integrate that data in DNA-powered health, ancestry, and wellness products from an ever-growing list of name-brand and developer partners on our platform, including the Mayo Clinic, National Geographic, and LoseIt!
Our mission is to empower every person to improve their life through DNA. Accomplishing this is no small feat; it takes a community of pioneers to make a difference in the lives of millions. Our people are our power, and we have a dedicated team of experts in the fields of genetics, engineering, design, product and beyond who have united to champion better lives for all. We are here to accomplish something bigger than ourselves. Join us and make your difference.
We're headquartered in San Carlos, with additional offices in San Diego, San Francisco, and Denver. We've raised over $300 million from investors like Illumina (the world leader in genetic sequencing equipment), Warburg Pincus, Sutter Hill Ventures, Kleiner Perkins Caufield & Byers, and Draper Fisher Jurvetson Growth.
Heli...x is proud to be an equal opportunity employer, and committed to providing employment opportunities regardless of race, religious creed, color, national origin, ancestry, physical disability, mental disability, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, pregnancy, childbirth and breastfeeding, age, sexual orientation, military or veteran status, or any other protected classification, in accordance with applicable federal, state, and local laws.