GRAIL
GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured.
Menlo Park, CA
Hybrid

Staff Design Control Quality Engineer (New Product Development - IVD)

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GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com.

As a key member of the Quality team at GRAIL, the Staff Design Control Quality Engineer plays an integral role in supporting quality activities related to Design Control efforts in accordance with FDA, ISO, and other IVD regulations.This individual also supports the company’s quality system activities that comply with the FDA’s Quality System Regulations (QSRs), ISO 13485, CLIA/CAP, and applicable state requirements. The successful candidate will work with product development teams to ensure that appropriate design control measures are applied during development and transfer of Grail products. The individual will apply “systems” thinking and knowledge of medical device products, molecular diagnostics, applicable industry or regulatory standards, design verification and validation, manufacturing transfer, test method development principles, and risk management to support new and sustaining projects. 

You will

  • Work effectively and influence multiple functions (R&D, Operations, Product/Program, Regulatory, Supply Chain, Medical, Engineering, etc.) to ensure ensure teams understand and implement appropriate regulations for all areas of design controls, including risk management, development planning, inputs, user needs, design requirements, specifications, traceability, outputs, critical to quality (CtQ), design review, verification, validation, change control, protocols, and reports. 
  • Provide QA support for product development from feasibility through transfer into commercialization.
  • Support documentation appropriate for regulatory submissions.
  • Ensure design control documentation and requirements are met. Perform and review/approve design control and risk management activities. Facilitate Design Review activities and assess Quality readiness for Verification and Validation activities.
  • Work closely with research and development organizations to ensure potential product issues are identified and addressed in the design.
  • Work with product development teams to assess design changes from a systems perspective, identifying risks, delivering design mitigations and evaluating the effectiveness of the risk control measures.
  • Develop/oversee the FMEAs and other risk assessment processes and documentation (as required).
  • Ensure Quality Risk Management Files are in alignment with 21CFR Part 820 design control and risk management requirements of ISO 14971:2012.
  • Anticipate and manage project risks and issues.
  • Work on complex technical problems, utilize quality engineering methods and provide innovative solutions.
  • Design, develop, approve, and implement Design Control Quality Systems SOPs, forms, reports, protocols, and documents associated with design controls processes.
  • Provide coaching to QA, product development, key stakeholders personnel on Quality Systems requirements and Design Controls.

You education and background will include

  • Minimum of a Bachelor of Science Degree in a related scientific or engineering field.
  • 5+ years Quality and/or Development experience in product development, product transfer, verification, and validation under Design Controls in the life sciences industry, preferably in a FDA regulated medical device/IVD environment.
  • Working knowledge of medical device / in vitro diagnostic regulations (e.g., FDA 21 CFR 820, ISO 13485, IVDD, ISO 14971, CAP/CLIA, and other applicable quality and regulatory standards).Extensive experience and understanding of design, development, verification and validation processes.
  • Ability to successfully balance and prioritize multiple ongoing projects/tasks in a fast-paced, deadline driven environmentEffective verbal and written communication skills and the ability to share and receive information from all levels of the organization throughout various departments.
  • Travel may be required up to 15% of the time, both domestically and internationally.
  • Must be able to work in a biohazard environment and comply with safety policies and standards outlined in the Safety Manual.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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What are GRAIL Perks + Benefits

GRAIL Benefits Overview

We’re committed to creating the best experience for everyone at GRAIL, ensuring that each member of our team has comprehensive benefits and resources to thrive at all stages of life, both at work and at home.

Culture
Volunteer in local community
We parter with Bay Area local partners such as Life Science Cares to help meet basic needs in the community.
Partners with nonprofits
GRAIL partners with The Honor Foundation to facilitate mock interviews to help military professionals transition to civilian life. Also oSTEM and The National Sales Network to identify diverse talent.
Open door policy
OKR operational model
Team based strategic planning
Open office floor plan
Employee resource groups
Employee-led culture committees
Hybrid work model
In-person all-hands meetings
Employee awards
Flexible work schedule
Remote work program
Diversity
Dedicated diversity and inclusion staff
Mandated unconscious bias training
Unconscious bias training is included as part of our standard interview training. We also have a formal training on the topic of unconscious bias that is facilitated by the People Team.
Diversity manifesto
Mean gender pay gap below 10%
Diversity employee resource groups
GRAIL proudly offers 4 employee resources groups led by team members in tandem with an executive sponsor. They include: ASERG, WERG, PRIDE, and BIPOCC.
Hiring practices that promote diversity
GRAIL's Talent team has partnered with a variety of non-profits, associations and job boards including WITI, oSTEM, THF, DiversityJobs and The National Sales Network to identify diverse talent.
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability insurance
Dental insurance
Vision insurance
Health insurance
Life insurance
Wellness programs
Team workouts
Mental health benefits
Abortion travel benefits
Financial & Retirement
401(K)
401(K) matching
Company equity
Performance bonus
Pay transparency
Child Care & Parental Leave Benefits
Childcare benefits
Generous parental leave
Family medical leave
Company sponsored family events
Fertility benefits
Vacation & Time Off Benefits
Unlimited vacation policy
Paid holidays
Paid sick days
Flexible time off
Bereavement leave benefits
Company-wide vacation
Office Perks
Commuter benefits
Company-sponsored outings
Free daily meals
Free snacks and drinks
Some meals provided
Company-sponsored happy hours
Onsite office parking
Recreational clubs
Relocation assistance
Onsite gym
Professional Development Benefits
Job training & conferences
Promote from within
Mentorship program
Online course subscriptions available
Paid industry certifications

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