Quality Systems Engineer

About MP Biomedicals:

MP Biomedicals is a global life science company with headquarters in California and regional offices across the globe. The company offers a diverse portfolio of life science products, fine chemicals, and diagnostics used in industries ranging from basic research to clinical diagnostics and pharmaceuticals. Over the past 50 years, we have provided quality tools and expert services to assist our customers in making breakthrough discoveries and achieving scientific excellence.

Company Misson Statement:

Our mission is to empower global research that unlocks life-changing solutions and inspires a meaningful life.

Company Values:

• Respect
• Meaningful Work
• Career Development
• Accountability
• Honesty

MP Biomedicals Benefits:

• Bonus Pay
• Monthly Childcare Credit
• Free breakfast on Mondays
• Free Catered Lunches Tuesday-Friday
• Paid Vacation
• Paid PTO Hours
• 10 Paid Company Holidays per Year
• 401k with Company Match
• Competitive Healthcare Benefits
• HSA
• Company Paid Life Insurance and Short-term Disability
• Learning and Development Program
• Employee Referral Program
• Employee Assistance Program
• Employee Discounts
• And so much more!

Coordinate and lead all activities related to quality systems (ISO9001 and ISO13485); improve and maintain all necessary documents related to the quality systems. Participate in the quality activities for both the Life Science and Diagnostics sections.

Responsibilities:

• Coordinating and investigating quality related customer complaints.
• Participate in customer audits and ISO (re)certification and internal audits.
• Prepares reports and/or necessary documentation; coordinate the monthly CAPA meeting and prepare the meeting minutes.
• Coordinate and participate in supplier qualification and supplier change control.
• Prepares customer questionnaires, forms, and other quality-related documents.
• Works directly with operations and QC to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
• Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audit process.
• Continuously improve any potential deficiencies in the quality management system through internal and external auditing
• Data analysis for metrics reporting, performance to established plans and root cause and risk analysis.
• Cross-train across related functions to ensure operational flexibility and team coverage.
• Maintain a foundational understanding of this position and other similar roles to provide support during staff absences, peak demand, or special projects.
• Perform all other duties as assigned, including any additional responsibilities necessary to support the success of the department and organization.

Education & Experience:

• Bachelor’s degree required in engineering, science, or technical studies.
• Minimum of 1-3 years of relevant experience
• Quality Management System (ISO 9001,13485) Experience
• Quality System Regulation (21 CFR 820) Experience
• Audit – Quality and Compliance Experience
• Corrective and Preventive Action (CAPA) Experience (i.e., application of root cause analysis tools for nonconformance investigations)
• Process and product Change Control Experience
• Strong and effective skills for the following: communication (verbal and writing), critical thinking, interpersonal communication, organization, time management, and presentation
• Proficiency in Microsoft Office applications (i.e., Word, Excel, PowerPoint)

Work Environment:

• Office (Primary); Use of standard office equipment such as computer, phone, photocopiers, video conferencing equipment.
• May also be required to work in the manufacturing environment for short periods to complete essential duties.
• PPE as required.
• Physical demands include sitting, bending, or standing for extended periods of time (1 hour or longer), including sitting in front of a computer or laptop.