Job Details

Join to apply for the Quality Engineer II role at Bio-Rad Laboratories

Join to apply for the Quality Engineer II role at Bio-Rad Laboratories

Direct message the job poster from Bio-Rad Laboratories

Recruiting top talent that serve life science research and clinical diagnostics customers, helping people live longer, healthier lives.

The Bio-Rad Laboratories Design Quality Assurance team is seeking a detailed oriented Quality Engineer to support software life cycle management of life science and clinical diagnostics product designs. You will work closely with local and global cross functional team members and play an essential role in ensuring software product design sustaining activities meet regulatory and quality requirements and support design control, risk management and product development activities throughout the products' lifecycle.

How You'll Make An Impact

• Collaborate with global cross-functional teams (R&D, Regulatory, Manufacturing, etc.) to ensure life cycle management activities align with applicable regulations (e.g., FDA 21 CFR Part 820, MDSAP, IVDR), standards (ISO 13485, ISO 14971, IEC 62304, etc.) and internal quality requirements.
• Review, approve, update and maintain supporting design change documentation including Design History Files (DHF), Design Input/Output documentation, Verification and Validation plans and reports.
• Facilitate and support Risk Management activities per ISO 14971 and internal procedures, including creation and maintenance of risk documentation (plans, reports, FMEA, Hazard Analysis).
• Provide quality oversight and guidance during the product design change projects, including design reviews, traceability, and process development.
• Support verification and validation testing by reviewing protocols, reports, and ensuring traceability.
• Collaborate in the transfer of product changes into manufacturing, ensuring quality compliance.
• Participate in internal and external audits, including remediation activities when needed.
• Support CAPA investigations and change control processes related to design and development as needed.
• Stay current with industry standards, regulatory updates, and best practices relevant to IVD, research use only and software products.
  
  

What You Bring

• Education/Work Experience: 2+ years of experience (or an equivalent combination of education and experience) and a B.S./B.A. (or equivalent) in a computer science, information technology, scientific or engineering discipline.
• Basic knowledge of and application of Quality Engineering and Risk Management principles required.
• Understanding of GMP/ISO regulations (ISO 14971, ISO 13485, IEC 62366, MDSAP, IVDR and FDA 820/210/211).
• Understanding in software development including IEC 62304.
• Detail-oriented, excellent organization and project management skills.
• Strong critical thinking, leadership, and communication skills, with a collaborative attitude and an eagerness to make an impact in a dynamic environment.
• SalesForce, SAP and Power BI experiences, Six Sigma Green or Black Belt certification is a plus.
  
  

Total Rewards Package: At Bio-Rad, we're empowered by our purpose and recognize that our employees are as well. That's why we offer a competitive and comprehensive Total Rewards Program that provides value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Bio-Rad's robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee's work and life cycle.

Benefits: We're proud to offer a variety of options, including competitive medical plans for you and your family, free HSA funds, a new fertility offering with stipend, group life and disability, paid parental leave, 401k plus profit sharing, an employee stock purchase program, a new upgraded and streamlined mental health platform, extensive learning and development opportunities, education benefits, student debt relief program, pet insurance, wellness challenges and support, paid time off, Employee Resource Groups (ERG's), and more!

Compensation: The estimated base salary range for this position is $84,300 to $116,000 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. This position is eligible for a variable annual bonus, which is dependent upon achievement of your individual objectives and Company performance.

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. 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.

Legal Entity: (USA_1000)Bio-Rad Laboratories, Inc.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

Referrals increase your chances of interviewing at Bio-Rad Laboratories by 2x

Get notified about new Quality Engineer jobs in Hercules, CA.

Oakland, CA $130,000.00-$190,000.00 3 weeks ago

Bay Point, CA $95,000.00-$115,000.00 1 week ago

Brisbane, CA $140,000.00-$160,000.00 2 days ago

San Francisco, CA $128,400.00-$160,500.00 2 weeks ago

Alameda, CA $95,000.00-$127,000.00 1 week ago

San Leandro, CA $70,500.00-$130,500.00 2 days ago

Alameda, CA $86,700.00-$173,300.00 4 days ago

Alameda, CA $86,700.00-$173,300.00 3 weeks ago

Textile Quality Engineer- San Francisco, CA (1099 Auditor)

Richmond, CA $138,168.00-$241,860.00 22 minutes ago

Staff/Senior Staff Customer Quality Engineer

Alameda, CA $132,000.00-$197,000.00 2 weeks ago

Alameda, CA $95,000.00-$127,000.00 1 week ago

Alameda, CA $165,000.00-$200,000.00 1 day ago

San Francisco, CA $150,000.00-$190,000.00 4 months ago

Air Quality Engineer/Scientist (Environmental Compliance Specialist)

Alameda, CA $113,000.00-$157,000.00 3 days ago

Applications Quality Engineer / Sr. Engineer

San Francisco, CA $120,000.00-$150,000.00 1 month ago

PCBA Quality Electrical Engineer II (Medical Device)

Alameda, CA $95,000.00-$127,000.00 2 days ago

San Francisco, CA $150,000.00-$170,000.00 15 hours ago

San Francisco, CA $42.00-$47.00 7 hours ago

PCBA Electrical Manufacturing Engineer II (Medical Device)

Alameda, CA $95,000.00-$127,000.00 1 day ago

Brisbane, CA $100,000.00-$120,000.00 2 weeks ago

Manufacturing Engineer II - Electromechanical

Manufacturing Test Engineer, Energy Storage

San Francisco, CA $45.00-$51.00 3 weeks ago

We're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr