Staff Supplier Quality Engineer

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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 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.

• The Staff 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.

• The Staff Supplier Quality Engineer maintains the qualification of suppliers and their processes as well as lead activities associated with resolving complex technical issues that may require the development of new or improved techniques or procedures. The position is the technical specialist able to make independent decisions on technical problems and methods provide technical leadership and project management to qualify and improve supplier processes for the manufacture of medical devices.

DUTIES & RESPONSIBILITIES

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

• Support Quality Systems including change control supplier non-conformances ASL management Quality Agreements and department procedures and system as assigned.

• Perform and Support supplier/ EM quality evaluations and/or audits development of quality agreements and other quality related activities impacting supplier.

• Lead activities associated with resolving supplier quality issues. This includes working with suppliers and internal partners to perform root cause analysis/failure investigations identifying and implementing corrective actions and monitoring for effectiveness.

• Lead activities associated with supplier risk management. This includes working with suppliers to identify areas of high risk within their processes; establishing monitoring and implementing supplier risk mitigation plans; participating in supplier risk management projects; and ensuring management awareness of risks gaining support for mitigation efforts and tracking progress.

• Lead activities associated with supplier process improvement. This includes working with suppliers to identify sources of variation within their processes; implementing process controls to improve process capability; and driving implementation of best practices.

• Provide Quality Engineering support to suppliers including assessments inspection technique support verification/validation activities CAPA and change management. FDA CFR Part 820 and ISO 13485 regulations/standards focus.

• Champions compliance to validation regulations & standards (e.g. QSRs ISO EN and MDD/MDR) including providing support during internal and external audits.

• Utilizes multifaceted industry and process excellence standards on an expert level in daily quality operations including good manufacturing practices (GMP) equipment engineering system (EES) and international organization for standardization (ISO).

• Develop and report on supplier performance metrics. Participate in local site supplier quality meetings to ensure communication and alignment of quality initiatives.

• Responsible for communicating business related issues or opportunities to next management level.

• 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

• Bachelors Degree is required; Masters Degree is preferred

• Generally requires 4 6 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

• Excellent communication teamwork and problem-solving skills are required

• Expertise in all aspects of quality event investigations such as root cause analysis followed by comprehensive corrective action suggestions

• Experience with machining injection molding metal processing such as passivation anodizing and heat treating and/or electronics assembly are preferred

• FDA CFR and ISO regulations knowledge is required with FDA CFR Part 820 and ISO 13485 knowledge preferred. Auditing background is a plus

• Six Sigma Lean American Society for Quality (ASQ) certification and professional licenses are preferred

• Strong statistical analysis skills are preferred

• Fluency in English is required

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 Staff Supplier Quality Engineer may 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% - 30% 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:

Coaching Communication Compliance Management Controls Compliance Cross-Functional Collaboration Data Compilation Econometric Models ISO 9001 Issue Escalation Performance Measurement Problem Solving Quality Control (QC) Quality Standards Standard Operating Procedure (SOP) Technologically Savvy Vendor Selection

The anticipated base pay range for this position is :

$94000.00 - $151800.00

Additional Description for Pay Transparency:

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



This position is eligible to participate in the Companys 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: - Experience:

Staff IC