Quality Engineer

2 weeks ago

Irvine, United States Bio-Rad Laboratories Full time

As part of the global PSUR Reporting Team, the candidate will be facilitating business data collection and reporting efforts and generating periodic product PSUR / post market surveillance reports. This includes regular interactions with area subject matter experts to ensure data is collected, documented, and analyzed in a timely and accurate manner. The candidate will use local and global systems to collect various post market information such as complaint, field corrective action and CAPA data. In addition, the QE will work with subject matter experts to analyze product related data and document conclusions of the review activities.

This position is eligible for a hybrid schedule Irvine or Hercules, CA

How You‘ll Make An Impact:

  • Facilitation and generation of product Post Market Surveillance (PMS) and PSUR reports including:
  • Analysis of post market data and reviewing completed reports with business partners.
  • Maintaining and supporting databases and systems used for tracking various quality management system (QMS) activities related to post market surveillance.
  • Maintain, archive and completed controlled quality records.
  • Coordinate PMS and post market performance follow-up (PMPF) deliverables with internal business partners.
  • Facilitate and/or chair local/regional PMS Board meetings.
  • Support various QMS and PMS projects (local and global) as needed.
  • Support internal/external audits as needed.
  • Perform other related duties and assignments as needed.

What You Bring:

  • Bachelor‘s degree or equivalent in a related life science/technical/engineering discipline or equivalent preferred.
  • 5+ years experience in a regulated manufacturing industry or equivalent combination of education and experience.
  • Understanding of GMP and quality system standards as they apply to products manufactured by Bio-Rad.
  • Understanding of product post market surveillance requirements for IVD products a plus.
  • Working knowledge of device/drug/biotech manufacturing processes.
  • Detail-oriented and ability to multitask.
  • Problem solving, decision making, time management, organization, communication, leadership, and computer skills.
  • Advanced technical writing and word processing skills.
  • Experience with electronic QMS systems (i.e. Veeva, EtQ, Trackwise) a plus

Compensation: The estimated hourly rate for this position is $38 - $52 per hour at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors. As a temporary associate, your employment will be managed directly through our approved agency provider.

Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.

EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with physical or mental disabilities, and people of all race, color, sex, sexual orientation, gender identity, religion, national origin and citizenship status are encouraged to apply.

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

Fraud Alert: Bio-Rad has received reports of individuals posing as Bio-Rad recruiters to obtain information, including personal and financial, from applicants. Beware of these fake ‘recruiters‘ and job scams. Click here for more information on this scam and how to avoid it.

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