Sr. Supplier Quality Engineer

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:

Supplier Quality

Job Category:

Professional

All Job Posting Locations:

Blackpool, Lancashire, United Kingdom, Leeds, West Yorkshire, United Kingdom, Oberdorf, Basel-Country, Switzerland, Palm Beach Gardens, Florida, United States of America, Raynham, Massachusetts, United States of America, Suzhou, Jiangsu, China, Warsaw, Indiana, United States of America

Job Description:

JOB SUMMARY

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 Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials.

• The Sr. Supplier Quality Engineer provides overall quality assurance leadership in the management of select contract manufacturing sites and raw material suppliers engaged in the production of Johnson and Johnson products.

• Works collaboratively with management to drive decisions regarding Quality Engineering methods to produce leading-edge customer-tailored engineering final deliverables.

DUTIES & RESPONSIBILITIES*

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• 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.

• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable

• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

• Performs other duties assigned as needed

EXPERIENCE AND EDUCATION*

• 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

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*

• 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

ADDITIONAL POSITION REQUIREMENTS

• Ability to work in stressful/fast-paced environment

• Ability to work and interact with co-workers to accomplish company goals in a team environment

• Management Skills

• Analytical/Problem Solving Skills

• Ability to communicate verbally and in writing

• Ability to learn

RESPONSIBILITY FOR OTHERS & INTERNAL INTERACTIONS

• The Sr. Supplier Quality Engineer may directly or indirectly supervise and/or provide directions to other Supplier Quality Engineers.

• Collaborates with other functional departments such as Quality, Engineering, R&D, Regulatory and Sourcing

LOCATION & TRAVEL REQUIREMENTS

• Up to 10% of travel

EXTERNAL INTERACTIONS

• Interactions with customers of J&J is not required as part of job responsibilities

• All positions may interact with government agencies such as the FDA, Regulatory Agencies such as Notified Bodies and will interact with suppliers providing products and services that could impact the quality of J&J products

Required Skills:

Preferred Skills:

Analytical Reasoning, Business Behavior, Coaching, Compliance Management, Controls Compliance, Cross-Functional Collaboration, Data Compilation, ISO 9001, Issue Escalation, Persistence and Tenacity, Problem Solving, Quality Control (QC), Quality Standards, Quality Systems Documentation, Report Writing, Technologically Savvy, Vendor Selection

The anticipated base pay range for this position is :

$79,000.00 - $127,650.00

Additional Description for Pay Transparency:

ubject 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)).

This position is eligible to participate in the Company’s long-term incentive program.

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