Quality Process Lead

Johnson & Johnson Innovative Medicine•Raynham, MA

3d•$65,000 - $104,650•Hybrid

About The Position

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes. DePuy Synthes is recruiting for a Quality Process Lead. The preferred locations are Raynham, MA, West Chester, PA or Palm Beach Gardens, FL, but can be located anywhere is the US. Remote work options may be considered on a case-by-case basis and if approved by the company. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech In this role you report into the Manager Quality Process and are responsible for the overall and compliant execution of global Stop Shipments.

Requirements

High School diploma or equivalent required
2 years of related experience in a Quality environment
Strong proficiency with Microsoft Office tools, including Outlook, Excel, PowerPoint, Visio, and Office 365
Worked with ERP systems
Worked in a diverse, international work environment
Ability to work cross functional and with diverse teams
High degree of responsibility

Nice To Haves

Familiar with ISO and FDA standards for medical products (ISO 13485 and 21CFR820)
Knowledge in Process Improvements
Worked in a healthcare/medical device environment

Responsibilities

Responsible for the execution of Stop Shipment Cases
Coordinating, leading communication between stakeholders, LOCs, and management
Work with ERPs and provide ERP support and guidance.
Provide product traceability escalations and Field Actions
Changing, creating, and maintaining critical batch information (e.g. Expiry Date.)
Analyse, define, and revise procedures, work instructions and documentation as well as implement process opportunities.
Provide quality systems guidance and support the Non-Conformance, Complaint Handling and Work with stakeholders and provide support for investigations related to quality issues.
Serving as Subject Matter Expert during audits.

Benefits

Consolidated retirement plan (pension)
Savings plan (401(k))
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year (may vary by state)
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