Katalyst Healthcares & Life Sciences
Senior Quality Specialist, Sequencing
Katalyst Healthcares & Life Sciences, Belmont, California, United States, 94002
Job DescriptionThe 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.
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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.
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