As a Quality Engineer I you will utilize quality engineering principles, tools, and practices to develop, transfer and maintain products and processes throughout the product's lifecycle, ensuring that products meet quality standards consistent with internal procedures and acceptance criteria, while meeting all design control and applicable regulatory requirements. In addition to this, you will use risk management and problem solving skills to prevent unanticipated failure modes and improve capability of products and processes through recommendation of preventive and corrective actions. Responsible for executing all items regarding quality issues, complaints, validations, and other projects in support of life science and/or clinical diagnostic product manufacturing.
How You'll Make An Impact:- Providing engineering support to manufacturing and conducting the evaluation and disposition of nonconforming product and process-related issues using a risk-based approach to resolve problems impacting production fulfillment.
- Spending time on the manufacturing floor to identify process improvements, participating in investigations, root cause analyses, corrective action planning and implementation activities, and interfacing with cross-functional departments to improve product quality using recognized Six Sigma and Lean methodologies.
- Ensuring compliance with internal and external safety, quality, and regulatory requirements (e.g., FDA and ISO standards) by reviewing and approving product and quality system changes in partnership with Engineering and Manufacturing.
- Participating in Quality Review Boards, performing data analysis using appropriate statistical tools and techniques to identify trends, developing technical investigation plans, and recommending updates to quality standards and procedures as needed.
- Executing New Product Introduction (NPI) and Design Transfer activities by characterizing manufacturing processes for parts and components in development to ensure a successful transition from R&D to manufacturing, including participation in and leadership of equipment and process validation activities (FMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques.
What You Bring: - Education: Bachelor's degree (BA/BS) or equivalent
- Work Experience: 0-2 years experience or equivalent combination of education and experience.
- Basic knowledge of and application of principles and theories of quality engineering.
- Ability to work well in fast paced and cross-functional teams.
- Excellent verbal and written communication, problem solving, analytical skills required.
- Understanding of GMP/ISO regulations and validation regulations is preferred.
Location: This position must be based in
Hercules, CA and requires the employee to be located within commuting distance of the 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 $70,310 to $95,400 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.
Legal Entity: (USA_1000)Bio-Rad Laboratories, Inc.
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