Quality Sytems Engineer

MP Biomedicals is a global life science company with headquarters in California and regional offices across the globe. We offer 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.

Our mission: We fuel research, development, and commercialization to advance life sciences that improve the human condition.

Our values: accountability, adaptability, collaboration.

The primary function of the Quality System Engineer is to 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 Sciences and Diagnostics sections.

• 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.
• Participate in preparing 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 audits.
• 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 analysis.
• All other duties as assigned.

Preferred education and experience:

• Bachelor's degree required in engineering, science, or technical studies.
• Minimum of 3 years of relevant experience
• Quality Management System (ISO 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