Quality Process Lead

About the role

The Quality Process Lead role is being recruited by DePuy Synthes, a subsidiary of Johnson & Johnson, to support the execution of Stop Shipments globally. This role is part of the broader Quality Process team.

Responsibilities

• Execute Stop Shipment Cases
• Coordinate and lead communication between stakeholders, Local Operations Centers (LOCs), and management
• Work with Enterprise Resource Planning (ERP) systems and provide support and guidance
• Provide product traceability escalations and Field Actions
• Change, create, and maintain critical batch information (e.g., Expiry Date)
• Analyse, define, and revise procedures, work instructions, and documentation, and implement process opportunities
• Provide quality systems guidance and support Non-Conformance, Complaint Handling, and investigations related to quality issues
• Serve as a Subject Matter Expert during audits

Qualifications

• Education: High School diploma or equivalent required
• Experience: 2 years of related experience in a Quality environment
• Skills: Strong proficiency with Microsoft Office tools, worked with ERP systems, worked in a diverse, international work environment, ability to work cross-functionally and with diverse teams, high degree of responsibility
• Preferred Skills: Familiarity with ISO and FDA standards for medical products, knowledge in Process Improvements, experience in a healthcare/medical device environment

Qualifications

• Education: High School diploma or equivalent required
• Experience: 2 years of related experience in a Quality environment
• Skills: Strong proficiency with Microsoft Office tools, worked with ERP systems, worked in a diverse, international work environment, ability to work cross-functionally and with diverse teams, high degree of responsibility
• Preferred Skills: Familiarity with ISO and FDA standards for medical products, knowledge in Process Improvements, experience in a healthcare/medical device environment

Benefits

• Pension Plan
• 401(k) Savings Plan
• Vacation – 120 hours per calendar year
• Sick time – 40 hours per calendar year (State of Colorado: 48 hours, State of Washington: 56 hours)
• Holiday pay – 13 days per calendar year
• Personal and Family Time – up to 40 hours per calendar year
• 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