Quality Sytems Engineer

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.
• All other duties as assigned.
  
  

Education and 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.
  
  

MP Biomedicals offers a comprehensive list of benefits including:

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