Person, Clothing, Scientist, Lab, Coat, Sunglasses, Accessories, Lab Coat, Building, Clinic

Quality Control Mgr II

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.

Quality Control Mgr II

  • 2022-29139
  • Woodinville, Washington, United States

Bio-Rad is seeking a competent Quality Control Manager to lead the QC team for IVD product lines, including QC operations, material review board and participation in CAPA. This position requires strong GMP knowledge, and application of risk-based processes.

Responsibilities

Manages, leads, and develops team of QC Supervisors and QC team.

  • Manages ongoing collection, analysis and communication of QC data
  • Supports manufacturing schedule by managing QC resources
  • Supports material and quality review boards to process nonconformances, complaints and trends to identify and recommend corrective and / or preventive actions
  • Facilitates Cross-Functional Quality Meeting
  • May represent the company with FDA, ISO notified body, customers and vendors.
  • May assist in interpreting customer or marketing requirements.
  • Supports external audits and internal audit program as requested.
  • Assists in the design review of new or modified products. Challenges process designs to ensure manufacturability, safety and effectiveness of products.
  • Develops and delivers training materials as requested.
  • Supports product improvement projects to ensure compliance.
  • Develops, reviews and challenges existing quality system procedures.
  • Collaborates cross functionally on quality issues and ensures QC corrective actions are implemented.
  • Basic application of statistical tools and methods. Failure Mode and Effects Analysis (FMEAs) and develops fishbone analysis, control charts, and capability studies

Qualifications

 Bachelor's degree in a life science or related field

  • Advanced Degree preferred.
  • 10+ years quality control or manufacturing experience.
  • 8+ years of supervisory experience.
  • Strong communication, public-speaking, decision-making, MS Office, and negotiation skills.
  • Strong customer orientation and focus.
  • Excellent technical and analytical skills required.
  • Knowledge of the device/drug/biotech manufacturing process.
  • Familiarity with SAP or similar ERP systems a plus.

Thorough understanding of  ISO 13485, FDA regulations, GMP and GLP requirements required.Basic working knowledge of laboratory environments, materials, and apparatus.

 

Vaccination Requirement: 

 

Due to the higher threat of more infectious and deadly COVID-19 variant strains emerging, Bio-Rad has a mandatory vaccination policy requiring its US employees to be fully vaccinated against COVID-19 as a condition of employment. New hires will be asked to upload their vaccination card into our electronic database hosted by ClearPass, who specializes in securing electronic medical information, within 3 days of their start date. With this policy, Bio-Rad joins a growing list of companies that are prioritizing sound science and available facts to best ensure the ongoing safety of its employees and the community.

 

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

 

Agency Non-Solicitation:

 

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

#LI-PG1

 

 

More About Us

Couldn't find the role you were looking for?

Not You?

Thank you

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.

4_stars.png

“Cutting Edge Bio-Tech Company”

Senior SEO & Onsite Search Manager (Former Employee) Hercules, CA

"Bio-Rad is staffed by some of the smartest people in the industry, and offers a very good balance of work life..."

Other People Viewed

Product Manager, Translational Research 2022-29351 Pleasanton California United States Pleasanton, California, United States Project/Program Management We are looking for a highly motivated product manager to join our fast-paced team in the Digital Biology Group at Bio-Rad Laboratories, where we’re changing the world by pushing the boundaries of research and diagnostics with Droplet Digital PCR. ...
Senior Scientist - $5,000 Hiring Bonus 2022-29286 Hercules California United States Hercules, California, United States Scientist Bio-Rad Laboratories is seeking a highly motivated individual to join the Molecular and Cell Biology R&D team as a Senior Scientist. This position involves the research and development of new Molecular and Cell Biology products and solutions.   Th...
Field Service Engineer 2022-28191.1 San Francisco California United States San Francisco, California, United States Field Service/Support Bio-Rad is looking for a Field Service Engineer who will perform repairs, upgrades, and preventive maintenance on our Clinical Diagnostics instruments for customers within hospitals and laboratories based out of the Bay Area of Northern California...
Senior Supplier Engineer 2021-26592.1 Hercules. Pleasanton. Boulder. Ann Arbor California. Colorado. Michigan United States Hercules, California, United States. Pleasanton, California, United States. Boulder, Colorado, United States. Ann Arbor, Michigan, United States Procurement The Sr Supplier Engineer will be a key employee of the new NPI-Procurement Engineering Sourcing Project, and will be assigned to work directly with an R&D Engineering Team at the onset of a new Design Project. This person is responsible for ensuri...
Research Associate I 2022-29265 Hercules California United States Hercules, California, United States Research Bio-Rad Laboratories is seeking a highly motivated individual to join the Chemistry R&D team as a Research Associate.  The candidate will be involved in the research and development of antibody conjugate and affinity chromatography products and wi...
Admin Associate, Senior Staff - $2,000 Hiring Bonus 2022-28387.1 Hercules California United States Hercules, California, United States Administrative Bio-Rad is looking for an Administrative Associate, Senior Staff.   This position is eligible for a $2,000 HIRING BONUS:    Bonus offered for a limited time only. Bonus applicable to specific positions as labeled. Bonus recipients must be employe...