Job Details

The Bio-Rad Irvine Distribution Center requires a dedicated Quality System Specialist to provide 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 commercial 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 excellent leadership, communication, critical thinking, and organizational skills.LocationThis 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 ImpactManage the ongoing collection, analysis and communication of QMS performance data.Communicate quality-related regulatory requirements to the organization.Promote use of risk-based approaches.Approve correction, containment and communication in response to identified product performance issues.Promote use of sound investigation and corrective action methods and statistical techniques.Authorize product and process changes with moderate to high complexity or impact.Serve as the Quality Management Representative for the Quality Management System.Manage the site QMS documentation management process.Coordinate the site internal audit program.Act as the primary point of contact for audits and inspections.What You BringBachelor's degree in Engineering, Biology, Chemistry, or related discipline.Minimum 3–5 years relevant experience, or equivalent combination of education and experience, in 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 implementation of QMS processes, procedures, and activities.Experience supervising/managing quality systems in a regulated environment.Strong communication, public speaking, decision‑making, word processing, spreadsheet, and negotiation skills.Certification as an ISO9001 and/or ISO13485 lead auditor is a plus.Audit experience (internal, external, third‑party).Strong customer orientation and focus.Project management, multitasking, organizational, interpersonal, and leadership skills a must.Ability to drive continuous improvement.Total Rewards PackageAt Bio‑Rad, we offer a competitive and comprehensive Total Rewards Program that provides value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Our robust offerings 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.BenefitsWe offer competitive medical plans for you and your family. Additional options include free HSA funds, a new fertility offering with stipend, group life and disability, paid parental leave, 401(k) plus profit sharing, employee stock purchase program, an upgraded 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.CompensationThe 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 and is based on several factors including geographic location, experience, knowledge, skills, abilities, and other job‑permitted factors. The position is also eligible for a variable annual bonus, which is dependent upon achievement of your individual objectives and company performance.Who We AreFor 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.EEO StatementBio‑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.#J-18808-Ljbffr