Sr Supplier Quality Engineer

Johnson Johnson; Town of Florida (NY); On-site; USD 90,000 - 110,000; Full time

Job summary

Johnson & Johnson is seeking a Sr. Supplier Quality Engineer for the DePuy Synthes unit in Palm Beach Gardens, FL. The role focuses on implementing SQ strategy, managing supplier NC/CAPA, and supporting supplier validation and audits.

Ideal candidates have 2–4 years in GMP/ISO environments, strong root-cause analysis, and effective communication skills. Travel up to 10% and experience with medical device quality systems are a plus.

Qualifications

• Bachelor's or equivalent university degree in Engineering, Life Science, or related field.
• 2–4 years of experience in GMP/ISO regulated industries.
• Fluency in English; travel up to 10%.
• Knowledge of FDA CFR Part 820 and ISO 13485 preferred.

Responsibilities

• Implement SQ strategy and follow Supplier Quality standards.
• Manage supplier related Non-Conformities and CAPA.
• Oversee supplier change requests (SCR).
• Support Process Validations at suppliers.
• Support QE with supplier PVE's (First Article Inspection, Control Plans, CTQ, Capability studies).
• Contribute to product investigations related to product and process complaints.
• Provide Supplier Quality Engineering support for PLM changes.
• Support supplier preparation for inspections by authorities/third parties
• Support Procurement executing supplier transfer projects
• Support for Quality and Change Agreements, supplier assessments and audits
• Report on supplier performance metrics and management reviews.

Skills

Strong communication

Teamwork

Problem solving

Root cause analysis

Analytical thinking

Ability to learn

Education

Bachelor's degree in Engineering/Life Sciences

Job description

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: Supply Chain Engineering

Job Sub Function: Quality Engineering

Job Category: Scientific/Technology

All Job Posting Locations: Palm Beach Gardens, Florida, United States of America

Job Description:

DePuy Synthes, a member of Johnson & Johnson's Family of Companies, is recruiting for a Sr. Supplier Quality Engineer to be located in Palm Beach Gardens, FL .

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

Key Responsibilities

• Implement SQ strategy and follow Supplier Quality standards
• Manage supplier related Non-Conformities (NC/ SCAR) and Corrective and Preventive Actions (CAPA)
• Oversee supplier change requests (SCR)
• 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 product and process complaints.
• Provide Supplier Quality Engineering support for PLM changes.
• 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
• Report on supplier performance metrics and management reviews.
• 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.
• 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
• May directly or indirectly supervise and/or provide directions to other Supplier Quality Engineers.
• Collaborate with other functional departments such as Quality, Engineering, R&D, Regulatory and Sourcing
• 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
• Performs other duties assigned as needed

Qualifications

Education

• Bachelor's or equivalent university degree is required; A concentration in Engineering, Life Science, or related field is preferred

Experience and Skills

Required:

• A minimum of 2-4 years of experience in a GMP and/or ISO regulated industry
• Strong communication, teamwork, and problem-solving skills
• Strong root cause analysis skills
• Ability to work in stressful/fast-paced environment
• Ability to work and interact with co-workers to accomplish company goals in a team environment
• Analytical/Problem Solving Skills
• Ability to communicate verbally and in writing
• Ability to learn

Preferred:

• Experience in the medical device and/or pharmaceutical industry
• FDA and ISO regulations knowledge
• Experience or knowledge with machining manufacturing processes, injection molding, robotics, electronics and/or software
• Operations supplier quality experience
• FDA CFR Part 820 and/or ISO 13485 knowledge
• Auditing background
• Management skills

Other

• Fluency (oral & written) in English is required
• Up to 10% travel may be required
• Six Sigma, Lean, or ASQ Certification and professional licenses preferr