Quality Systems Project Engineer

6045-Ethicon Legal Entity • Cincinnati, NJ

9h • Hybrid

About The Position

The Quality Systems Project Engineer supports the Ethicon Quality System by driving CAPA/NC data analysis, promoting robust failure investigations, and advancing quality improvement initiatives. In partnership with the MedTech Quality Business Enablement and E2E Productivity & Innovation Q&C, this role actively drives projects that enhance Quality System effectiveness, compliance, and operational performance. The position monitors quality system processes and metrics, serves as a coach and advocate for quality excellence, and collaborates across the Ethicon Franchise to support the harmonization and integration of optimized Quality System processes.

Requirements

• Minimum of 4-6 years of experience working in an Operations, Manufacturing, Quality and/or Engineering role
• Experience working in an FDA regulated environment
• Strong communication, human relation, problem solving and analytical skills
• Demonstrated skills in root cause analysis and failure investigation
• Ability to communicate effectively with all levels of management and functions is required
• Experience in dealing with audits/ inspections with the FDA, other notified bodies or any other Health Authority

Nice To Haves

• Demonstrated Project Management skills with a strong results orientation
• Strong in ability to build collaboration, partnership and teamwork across local and global organizations
• Demonstrated proficiency in problem solving skill sets and good analytical skills
• Demonstrated leadership skills without direct authority responsibility
• Demonstrated effectiveness as a team member and a team leader

Responsibilities

• Serves as a Quality Systems SME, tracking and reporting CAPA/NC action plans while supporting effective failure investigations, root cause analysis, and Quality System improvement efforts.
• Provides training regarding Quality Management System Elements (including, but not limited to CAPA, NC, DRB, Management Review, Quality Planning, Quality Manuals & Metrics) to representatives from other functional areas.
• Partners with E2E Productivity & Innovation Q&C and the MedTech Quality Business Enablement team to support Quality projects and initiatives that improve Quality System effectiveness, compliance, and operational performance.
• Manages cross-site citizen developed applications, ensuring proper maintenance according to the Master Validation Plan.
• Facilitates or supports meetings (including, but not limited to CAPA, NC, DRB, Management Review, Quality Planning, Quality Manuals & Metrics).
• Monitors and reports Quality Management System metrics.
• Works on complex investigations and coordinates technical teams and leads cross functional teams to ensure sound experimental design, effective data analysis, identification, implementation, verification and validation of CAPA, Non-Conformance, and subsequent closure of investigations.
• Identifies opportunities to continuously improve quality systems and processes in alignment with overall quality and business objectives.
• Supports, participates, and leads in cross-functional projects when assigned/appropriate.
• Provides audit support for 3rd Party Inspections (e.g. Registrar, Notified Body, FDA, or customer audits).
• Completes assessments for internal and external standards and regulations across Ethicon sites.
• Processes document changes in applicable document management systems as needed including maintenance of Franchise Quality Manuals and Quality Planning procedures.
• Provide leadership on optimization and harmonization Quality projects across Ethicon.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed.

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
• 10 days Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level