Quality Process Lead

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Business Process Quality

Job Category:

Professional

All Job Posting Locations:

Raynham, Massachusetts, United States of America, Remote (US)

Job Description:

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.

Key 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.

Qualifications

Education:

• High School diploma or equivalent required

Experience and Skills:

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

Preferred:

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

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

 

 

Preferred Skills:

Accountability, Business Behavior, Business Process Management (BPM), Business Requirements Analysis, Compliance Management, Cross-Functional Collaboration, Data Reporting, Detail-Oriented, Execution Focus, Goal Attainment, Leverages Information, Process Optimization, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Report Writing, Technical Writing

 

 

The anticipated base pay range for this position is :

$65,000.00 - $104,650.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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 period10 days

Volunteer Leave – 32 hours per calendar year

Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits