Quality Engineer focusing on AI and ML healthcare solutions at Vizient. Responsible for validating data quality, model performance, and safe deployments across various collaborative teams.
About the role
- Provide quality assurance leadership in managing contract manufacturing sites for Johnson & Johnson. Oversee supplier quality metrics and support quality engineering methods in pharmaceuticals.
Responsibilities
- Implement SQ strategy and follow Supplier Quality standards
- Manage Supplier related Non-Conformities (NC and SCAR's) and Corrective and Preventive Actions (internal CAPA's)
- Oversee supplier change requests (SCR) with Procurement
- Support Process Validations at suppliers
- Support QE with supplier product PVE's (First Article Inspection, Control Plans, Critical to Quality, Capability studies)
- Contribute to product investigations related to SCAR internal CAPA
- Support supplier preparation for inspections by authorities / third parties
- Support Procurement executing supplier transfer projects
- Support for Quality Agreement and Change Agreements, supplier assessments and supplier audit process
- Prepare regular report and supplier quality metrics
- Lead or participate in Quality projects: Legacy review, remediation, integration
- Implementation of improved/new standards for supplier quality
- Responsible for communicating business related issues or opportunities to next management level
- Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Requirements
- Bachelor's Degree is required
- Generally, requires 5-7 years of work experience in a GMP and/or ISO regulated industry
- Experience in the medical device / pharmaceutical industry is preferred
- Engineering or science field of study is preferred
- Strong communication, teamwork, and problem-solving skills are required
- Experience in machining, injection molding and/or electronics assembly is preferred
- FDA CFR Part 820 and/or ISO 13485 knowledge is preferred
- Six Sigma, Lean, American Society for Quality (ASQ) certification and professional licenses are preferred
- Fluency in English is a must
Benefits
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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