Person, Clothing, Apparel, Clinic, Lab Coat, Coat, Hospital, Nurse, Sleeve

Lead Internal Auditor

IMPORTANT ALERT FOR JOB APPLICANTS!
Bio-Rad has received reports of individuals posing as Bio-Rad recruiters to obtain information from applicants. Be aware that Bio-Rad strictly adheres to these hiring practices.

Lead Internal Auditor

  • 2020-16451.1
  • Redmond, Washington, United States

The Seattle Operations (SO) Lead Auditor is a Regulatory Affairs Specialist responsible for coordinating the internal audit program and external audits at SO. The SO Lead Auditor leads and/or coordinates internal audits to assure that the SO QMS complies with applicable global regulatory standards as well as internal Bio-Rad quality objectives, policies, procedures, and standards. The SO Lead Auditor conducts regular Audit Readiness Team meetings to ensure that all external audit obligations are met in a timely manner and that the SO QMS is maintained in accordance with current requirements. The SO Lead Auditor supports internal audit activity at other Bio-Rad Core Diagnostics locations, as assigned. Future occasional travel will be required.

Responsibilities

  • Coordinate planning, approval, and execution of the annual internal SO audit schedule and program.
  • Facilitate external audit activity, including but not limited to pre-audit activity such as completion of questionnaires, provision of documents, payment of fees, and completion of contractual documents / agreements.
  • Provide direct and indirect support to audits by external parties.
  • Leads and facilitates internal teams to ensure that external audit commitments such as responses and corrective actions to findings are completed in a timely manner and that the SO QMS is maintained in compliance with relevant regulations, standards, and guidelines.
  • Prepares corporate and local standard operating procedures, training instructions, as well as inter-divisional company agreements.
  • Document management: maintains and stores current quality certificates, MOUs, contracts with auditing organizations, audit reports, Design History Files, and other records as assigned. Assists with management and oversight of the Regulatory Document File Room.

Qualifications

Education: Bachelor's degree or equivalent in Biology, Chemistry, Medical Technology, or related field.  Qualified Lead Auditor per Lead Auditor training and certification with a recognized accreditation body (ASQ certification preferred).

Experience: 5 or more years experience in regulated industry or equivalent combination of education and experience.  3 or more years working in the area of quality management systems and/or regulatory affairs

Skills:  Applicable regulations / standards training (i.e. ISO 13485, 21 CFR 820).  Working knowledge of global governing regulations, requirements, and standards such as 21 CFR Parts 803, 806, 820, 11, ISO 13485, ISO 14971, European IVD Regulation, and the Medical Device Single Audit Program / participating country regulations.

About Bio-Rad:

Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 8,000 employees and a global network of operations serving our customers, we help people live longer, healthier lives.

Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.

 

EEO/AA Employer/Veterans/Disabled/Race/Ethnicity/Gender/Age

To all recruitment agencies: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Staffing Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

 

 

 

 

Other People Viewed

Systems Engineer IV 2021-22565 Pleasanton California United States Pleasanton, California, United States Engineering The Systems Engineering Team is looking for an enthusiastic Systems Engineer to join our team and develop the most advanced ddPCR Systems on the planet. We need a solid systems engineer who gets excited about creating prototypes, is highly analyti...
Environmental Health & Safety Manager - Northern California 2020-16677.1 Hercules California United States Hercules, California, United States Environmental Health & Safety Bio-Rad is looking for an EH&S Manager I to oversee all environmental health and safety (EHS) activities/requirements within the Northern California region.  This includes EHS compliance, incident response and coordination, direction of assign...
Trade Compliance Specialist II 2021-18732 Hercules California United States Hercules, California, United States Trade Compliance The primary responsibilities of the Trade Compliance Specialist II are to assist the Trade Compliance Manager in the development, implementation and maintenance of both import and export compliance programs and GTS.  Strong emphasis on supporting ...
Account Executive - BioPharma 2021-22563 Massachusetts United States Massachusetts, United States Sales The successful BioPharma Account Executive will: Effectively promote and sell all Bio-Rad Genomics solutions, including Droplet Digital PCR and qPCR Systems and associated reagent content to achieve revenue targets. Demonstrate a strong Sales Proc...
Director, Regional Logistics – Americas 2020-17939 Hercules California United States Hercules, California, United States Logistics Bio-Rad is recruiting for a Director, Regional Logistics - Americas. The Director will manage a team of Logistics and Distribution Managers with 100+ direct and indirect staff located in multiple countries which includes Latin America, USA and Can...
Molecular Biologist 2021-18726 Ann Arbor Michigan United States Ann Arbor, Michigan, United States Research & Development We are seeking a scientist with excellent technical skills in molecular biology and/or biochemistry with good attention to detail and efficient work processes.  If you are the person that others turn to when things need to work then you will thriv...

Apply Now 

Alert me about jobs like this

Not You?

Thank you

Meet a Bio-Radian

Hear what it's like to work at Bio-Rad.

5_stars.png

“Bio-Rad Rocks! ... ”

Scientist (Current Empl.) Plano, TX

" ... In continuing the mission of Advancing Science and Improving Lives, you have the opportunity to make contributions to products that improve life on the planet Earth in meaningful ways. I love the get-the-job-done environment in Plano and being part of a team that delivers."

More About Us

Apply Now

Alert me about jobs like this

Not You?

Thank you