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Quality Manager I

4 months ago

Hercules, California, United States Bio-Rad Laboratories, Inc. Full time

Bio-Rad Clinical Diagnostics Group (CDG) is one of the leading global providers of tests for infectious and autoimmune disease screening, diabetes screening and monitoring, blood group typing, data management software solutions as well as quality control products for clinical laboratories.

You will oversee a team that initiates, and owns product investigations identified through customer complaint escalations within the Bio-Rad Laboratories global complaint system. The team is also responsible for collaborating with Design Quality Assurance on investigating complaint/CAPA related design changes or improvements to ensure all issues and failures are adequately addressed. You will use your strong technical understanding of our products and proficiency in investigation and root cause analysis methodologies in this role.

How You'll Make An Impact:

  • Provide training and guidance to a small group of Quality Engineers on root cause analysis and investigation methodologies within ISO13485 and ISO14971 standards.
  • Develop cross functional investigation teams to efficiently establish root cause for non-conformances discovered through product complaints.
  • Design, develop, implement, maintain, and continuously improve related processes and global procedures to ensure compliance with applicable internal and external quality and regulatory requirements including identification, management and escalation of identified issues and risks to appropriate business partners and senior management.
  • Establish, maintain, and report on quality metrics for product complaints and investigations, making recommendations where trends are realized.
  • Collaborate with New Product Development to manage complaint handling for new product launches and provide Quality oversight of design changes where appropriate.
  • Collaborate with the Post Market Surveillance team to ensure of existing and NPD product complaint data is delivered and represented in the Product Surveillance Reports owned by PMS.
  • Collaborate with Risk Management to ensure updates to dFMEA are made when new risks are discovered, or existing risk or risk controls need to be updated.
  • Represent Complaint Investigations and Quality Engineering for CAPA, Change Control and Management Reviews.
  • Leading the team with vision to initiate and develop processes that align with Bio-Rad Laboratories values and prioritizes product engaging the team with learning and development opportunities to build a highly developed group of Quality Engineers that will support stakeholders with direction and purpose.

What You Bring:

  • Education: Bachelor's degree in a technical discipline
  • Work Experience: 5-7 years of medical device or IVD experience with at least 2 years in a leadership role or function
  • Highly proficient in ISO13485 and ISO14971. Experience with IVDR preferred.
  • Technical background with the ability to speak to standard engineering practices and principles
  • Intrinsic curiosity and motivation to learn and contribute to continuous improvements initiatives
  • Proficient in Microsoft 365 and Salesforce (Veeva experience preferred)
  • Exhibiting a high level of emotional intelligence, patience and support to teams which are managing. shifting priorities.
  • Assertiveness and confidence to lead investigations and manage a dynamic team of professionals to achieve root cause and mitigation.

Location: Bio-Rad is pleased to offer the flexibility of a hybrid work environment for this role, 3 days in office, 2 days remote, working out of the Hercules, CA office

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 $102,200 to $140,500 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. 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. #LI-AK1



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