Sr Supplier Quality Engineer

jj; Town of Florida (NY); In loco; USD 79.000 - 128.000; Tempo pieno

Descrizione del lavoro

Johnson & Johnson, a leader in MedTech and healthcare innovation, is recruiting a Sr. Supplier Quality Engineer to be located in Palm Beach Gardens, FL.

You will lead supplier quality activities, manage NC/SCAR, CAPA, SCR, support process validations, and collaborate with QA, R&D, Regulatory, and Sourcing to ensure product quality across contract manufacturers and suppliers.

Competenze

• Bachelor's or equivalent university degree is required; A concentration in Engineering, Life Science, or related field is preferred
• 2-4 years of experience in a GMP and/or ISO regulated industry
• Fluency in English and strong communication skills

Mansioni

• Implement SQ strategy and follow Supplier Quality standards
• Manage supplier related Non-Conformities (NC/ SCAR) and CAPA
• Oversee supplier change requests (SCR)
• Support Process Validations at suppliers
• Support QE with supplier PVE's (First Article Inspection, Control Plans, Critical to Quality, Capability studies)
• Collaborate with other functional departments such as Quality, Engineering, R&D, Regulatory and Sourcing
• May interact with FDA and other regulatory bodies and suppliers

Conoscenze

Quality Engineering

Supplier Quality

GMP/ISO

Root Cause Analysis

Communication

Cross-functional collaboration

Formazione

Bachelor's degree in Engineering

Strumenti

CAPA

SCR

Process Validation

Descrizione del lavoro

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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:

Job Description:

DePuy Synthes, a member of Johnson & Johnson's Family of Companies, is recruiting for a Sr. Supplier Quality Engineer to be locatedin 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

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 DePuy Synthes products.

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

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 preferred

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:

Analytical Reasoning, Coaching, Customer Centricity, Data Savvy, Document Management, Financial Competence, Good Automated Manufacturing Practice (GAMP), Lean Supply Chain Management, Process Improvements, Quality Control Testing, Quality Services, Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically Savvy

The anticipated base pay range for this position is :

$79,000.00 - $127,650.00

Additional Description for Pay Transparency:

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