Bio-Rad Laboratories · 12 hours ago
Quality Engineer - Temporary
Hercules, CA
Contract
Onsite
Entry, Mid Level
$40.38/hr - $55.76/hr
2+ years expBio-Rad Laboratories, Inc. is a global leader in developing, manufacturing, and marketing high-quality research and clinical diagnostic products. The Quality Engineer will facilitate the updating and consolidation of legacy product risk management files related to IVDR, coordinate risk management assessments, and support migration into the eQMS system.
BiotechnologyHealth CareHealth Diagnostics
Responsibilities
Facilitating risk management assessments, updating risk plans and reports, consolidation and updating product system hazard analysis files in accordance with established company procedures and applicable standards
Coordinate and facilitate meetings with cross functional stakeholders as needed to obtain information and data needed for completeness and accuracy of risk profiles for existing hazards, and identification of new risks and hazards as needed. Escalate events to Management that require additional inputs or mitigations
Support product risk management file migration into the eQMS system including ensuring document meta data is accurate and files are accurately linked to legacy product DHF binders in coordination with DHF migration efforts
Assessing legacy risk documentation and identifying gaps against initial IVDR transitional activities versus new guidance documents and updates to global risk management procedures
Support other IVDR related technical documentation updates and gap assessments as required, including migration into eQMS as needed
Ability to work in an ever-shifting environment and possess a high level of patience to support cross functional teams with shifting priorities
A self-starter who can work independently and possesses a sense of ownership and accountability to the activities assigned to them
Qualification
Required
Bachelor's degree or equivalent in a related technical or engineering discipline
2-3 years experience or equivalent combination of education and experience
General knowledge of and application of principles and theories of quality engineering and risk management
Understanding of Medical Device/GMP/ISO regulations (ISO 14971, ISO 13485, MDSAP and FDA CFR Part 820), and FDA CFR Part 210/211 preferred
General understanding of risk management regulations, principles, and application
Excellent critical thinking, problem solving, coordination, teamwork, communication, technical and computer skills
Proficient in Microsoft Office, Visio
Preferred
Understanding of Medical Device/GMP/ISO regulations (ISO 14971, ISO 13485, MDSAP and FDA CFR Part 820), and FDA CFR Part 210/211 preferred
SAP, EtQ and/or Veeva experience a plus
Company
Bio-Rad Laboratories
Bio-Rad Laboratories has played a leading role in the advancement of scientific discovery for over 50 years by providing a broad range of
5001-10000 employees
H1B Sponsorship
Bio-Rad Laboratories has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (40)
2023 (41)
2022 (56)
2021 (45)
2020 (34)
Funding
Current Stage
Public CompanyTotal Funding
$1.4B2024-02-14Post Ipo Debt· $200M
2022-03-02Post Ipo Debt· $1.2B
1980-03-01IPO
Leadership Team
Christine A. Tsingos
EVP & CFO
Jonathan Divincenzo
President and Chief Operating Officer
Recent News
GlobeNewswire
2026-01-05
2025-12-15
Company data provided by crunchbase