Person, Glasses, Accessories, White Board, Finger, Classroom, Room, School, Indoors

Quality Engineer II

Quality Engineer II

  • 2022-30760
  • Irvine, California, United States

As part of Quality Engineering, this position will support the team by performing tasks within the technical review, new product development, risk management, and post market surveillance. This job includes detailed reviews of change requests, batch record, nonconfirming material reports, specifications, inserts, SDS, etc.

 

This position is eligible for a hybrid/flexible schedule. 

Responsibilities

  • Detailed review of manufacuring procedures, batch records, and specifications
  • Implementing changes based on quality plans, regulation changes, or other reasons
  • Review change records (labeling, manufacturing procedures, inserts, etc)
  • Review and update quality documentation including procedures, risk management reports, FMEA, validations, etc
  • Post-market surveillance data collection and report writing
  • Support new product development and product improvement projects
  • May represent the company with customers and vendors in resolving issues
  • General QE/QA tasks include records review, metrics and trending, etc

Qualifications

  • Bachelor's degree or equivalent
  • 2+ years experience in a regulated manufacturing industry or equivalent combination of education and experience
  • Detail-oriented and ability to multitask
  • Report writing skills
  • Basic understanding of GMP and quality systems standards desirable (13485 and IVDR)
  • Proficient on Microsoft 365, SharePoint, Smarsheet, Excel and Word
  • SAP knowledge a plus

Vaccination Requirement: 

 

Ability and consent to upload proof of completed Covid-19 vaccination into our secure database within 3 days of start date.

 

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-CH1

 

 

Other People Viewed

Marketing Manager II 2022-30398.2 Hercules California United States Hercules, California, United States Product Marketing You will be the Marketing Manager for our new Molecular Dx products with a focus on infectious disease within the US market. You will also be a key contributor on the infectious disease global marketing team and will support multiple initiatives a...
Market Development Manager (Chromatography) - $10,000 Hiring Bonus 2022-27955.2 Hercules California United States Hercules, California, United States Marketing A Snapshot of Your Day  As a Market Development Manager (Product Dev III) supporting our Protein Purification business, you’ll provide researchers with the chromatography tools they need to discover and purify proteins at every stage – from the la...
Material Handler - Temp 2022-30879 Richmond California United States Richmond, California, United States Warehouse/Distribution Performs a variety of routine, repetitive, physical and administrative tasks in a warehouse involving one or more of the following:  receiving, putting away, storing, staging, kitting, picking, packing and shipping of materials, parts, supplies, e...
Production Operator I 2022-30838 Santa Rosa California United States Santa Rosa, California, United States Manufacturing/Production This position will be in support of Bio-Rad's injection molding facility in Santa Rosa, CA. This position is responsible for the visual inspection and the packaging of injection molded product. Responsibilities You will be responsible for packagin...
Quality Mgr II 2022-30629 Irvine California United States Irvine, California, United States Quality & Regulatory QA Manager II reponsible for document control, change control, validation review board, eQMS implementation/maintenance, SAP master data, and batch record review/relelase. This employee will be responsible for a team of approx. 15 direct and indir...
Senior Financial Analyst 2022-30872 Hercules California United States Hercules, California, United States Finance As a Senior Financial Analyst at Bio-Rad you will be a key part of the Global Commercial Operations (GCO) finance team. You will partner with functional leaders to prepare budgets, forecasts, monthly financial analysis and reporting, and provide a...

Apply Now

Alert me about jobs like this

Not You?

Thank you

Meet a Bio-Radian

Hear from a current Bio-Rad employee. 

5_stars.png

“Engaging and friendly.”

Global Demand Planning Manager (Current Employee) Hercules, CA

"Bio-Rad's culture makes the workplace comfortable and familial. Employees are upbeat and enthusiastic about the company mission and products..."

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