Software Quality Assurance Director jobs in Fairfield, CA

Bio-Rad is seeking a Quality Assurance Operations Manager to join our Northern California QA Team to support Global Supply Chain operations across multiple plants located in Northern California. You will have 3-5 direct reports and responsibility for a total team of approximately 10 - 15 employees including QA Managers, Quality System Specialists and Quality Engineers. You will also oversee and standardize quality system practices that support manufacturing of diagnostic and life science products across multiple Northern California sites.

This includes activities such as:

• Product release and batch record review.
• Nonconforming product management.
• Act as Alternate Management Representative.
• Product & process transfer.
• Document and Record management.
• Process, equipment and software validation.
• Manufacturing and quality system related CAPA investigations.
• Internal/External/Regulatory audit support.
• Product transfer support.

How You'll Make An Impact:

• Collaborate with Quality Systems Manager and Global Design Quality Assurance organization to support initiatives in risk management, QMS harmonization, training, QMS performance monitoring and internal and external audits.
• Advise site-based teams with appropriate actions in response to identified product performance issues.
• Participate in the review and approval of technical design documentation such as requirements, risk analyses and validations in support of product development and transfer.
• Evaluate and authorize product & process changes as requested to ensure product conformity & regulatory requirements are met.
• Support a wide range of continuous and process improvement initiatives such as: annual quality planning, process flow mapping, employee training and collaborative global quality objectives.
• Promote an understanding of quality-related requirements and risk-based approaches throughout the organization.

What You Bring:

• Education: Bachelor's degree or equivalent in a related field.
• Work Experience: 8 years relevant experience with supervisory experience, or equivalent combination of education and experience.
• Experience supervising/ managing a quality assurance program in a regulated environment.
• Lead ISO auditor certification desirable.
• Quality Engineer, Quality Manager, Six Sigma Green or Black Belt Certification desirable.
• Skilled in statistical methods, statistical process control and sampling plans.
• Communication, public-speaking, decision-making, word processor, spreadsheet, and negotiation skills.
• Experience as a GMP and/or ISO trainer is highly desirable.
• Experience approving DHF, validation protocols and risk management files.
• Experience with risk management regulations and application.
• Advanced knowledge of the device/drug/biotech manufacturing process.
• Thorough understanding of 21 CFR 820 and ISO standards as they apply to products manufactured by Bio-Rad.

Location: On site in Hercules CA

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.

Compensation: The estimated base salary range for this position is $130,200 to $179,100 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. #LI-AK1