Senior Quality Specialist, Sequencing

Job Description

The Senior Quality Specialist, Sequencing will be a strong partner to the Global Quality and Regulatory function, as well as across the various Sequencing Unit functions.

Primary Job Responsibilities:

• Responsible for supporting management in developing and implementing Quality Management System (QMS) elements and supporting infrastructure/tools in compliance with FDA Quality System Regulation (QSR) regulations, International Standards Organization (ISO) regulations, and Roche corporate requirements.
• Provide Quality support for Document Management, Training Management, Supplier Quality, CAPA management, and Post Market Surveillance.
• Write and revise Quality Systems procedures as needed.
• Assists with Quality gap assessments and support closure of gap remediation action items.
• Is able to analyze QMS elements/processes and derive procedures to drive compliant implementation.
• Functions as the Quality lead for identification, execution, and implementation of process improvement activities, as appropriate.
• Expected to operate independently, holding him/herself accountable to proactively fulfill tasks and achieve results within assigned timelines.
• Must be able to travel to Belmont, CA (approx. 3-4 days a week) and to Pleasanton, CA (approx. 1-2 days a week).

Qualifications:

• Bachelor's degree in Biological Sciences, Engineering or related field, or equivalent combination of education and work experience.
• At least 5 years related experience in relevant medical diagnostic/device industry with experience focused on quality systems and/or quality operations.
• Exposure to software development a plus.
• ASQ Certified Quality Manager (CQM), Engineer (CQE), Auditor (CQA) and/or Six Sigma Black Belt a plus.
• Working knowledge of regulations: 21CFR 820, ISO 13485, IEC 62304 and ISO 27001.
• Enthusiasm for the role that Quality and Regulatory (Q&R) can play in enabling the development of new products for our patients by contributing in a startup environment with a passion to be a strong team member.
• Be flexible with changing priorities/tasks and a desire for continuous improvement.
• Drive to engage positively with Q&R/Business teams and make impactful contributions in a multi-cultural/national environment.
• Track record of providing sound Q&R judgment/ideas and business partnering.
• Strong leadership/interpersonal/integrating/problem-solving skills and demonstrated ability to collaborate effectively across a variety of workgroups in demanding/changing situations (medical, scientific, and manufacturing).

Additional Information

• Good working knowledge of project management activities.
• Interpersonal and professional skills to interact at all levels including senior executives, contractors and colleagues.
• Good written and verbal communication skills and ability to present and critically discuss data in both internal and external discussions.
• Highly organized, with exceptional good analytical and reasoning capability, ability to multi-task and prioritize.
• Thorough knowledge on analytical & numerical skills.