Quality Assurance Specialist

The Bio-Rad Irvine Distribution Center requires a dedicated Quality System Specialist to provide the leadership and direction needed to support Global Logistics operations at the facilities including regulatory compliance and the development, implementation, and continuous improvement of Quality Management System (QMS) programs compliant with all applicable regulatory requirements. This position will work across multiple functions, regions, divisions, and QMS in the business. The Quality System Specialist will be responsible for implementing, maintaining, and improving the commecial and distribution Quality Management System and effective quality system processes, providing quality oversight, and developing and leading the Quality Assurance function, ensuring that the QMS is effective and meets customer and regulatory requirements. This individual must demonstrate excllent leadership, communication, critical thinking, and organizational skills.

Location: This position must be based in Irvine, California and requires the employee to be located within commuting distance of the office.

How You'll Make An Impact:

• Manage the ongoing collection, analysis and communication of QMS performance data.
• Communicates quality-related regulatory requirements to the organization.
• Promotes use of risk-based approaches.
• Approves correction, containment and communication in response to identified product performance issues.
• Promotes use of sound investigation and corrective action methods and statistical techniques.
• Authorizes product and process changes with moderate to high complexity or impact.
• Serves as the Quality Management Representative for the Quality Management System.
• Managing the site QMS documentation managagement process.
• Coordinaitng the site internal audit program.
• Primary point of contact for audits and inspections.

What You Bring:

• Bachelor's degree in Engineering, Biology, Chemistry, or related discipline.
• Minimum 3-5 years relevant experience, or equivalent combination of education and experience, relevant medical device industry and quality systems experience in a regulated distribution/warehouse environment (Good Distribution Practices (GDP), ISO9001 and/or ISO 13485).
• Minimum 2 years experience working with ERP (enterprise resource planning) systems such as SAP or Oracle.
• Experience with the development and implemention of QMS processes, procedures, and activities.
• Experience supervising/managing quality systems in a regulated environment.
• Communication, public-speaking, decision-making, word processor, spreadsheet, and negotiation skils.
• Certification as an ISO9001 and/or ISO13485 lead auditor a plus.
• Audit experience (i.e. Internal, External, 3rd party).
• Strong customer orientation and focus.
• Project management, multitasking, organizational, interpersonal, and leadership skills a must.
• Ability to drive continuous improvement.

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 $86,600 - $119,200 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 also 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.

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