Sr Supplier Quality Engineer

6029-MEDICAL DEVICE BUSINESS SERVICES, INC. Legal Entity; Monet (FL); Vor Ort; USD 79.000 - 128.000; Vollzeit

Zusammenfassung

DePuy Synthes, a Johnson & Johnson company, is recruiting a Sr. Supplier Quality Engineer to be located in Palm Beach Gardens, FL. The Sr.

Supplier Quality Engineer provides overall quality assurance leadership in select contract manufacturers and raw material suppliers and drives CAPA, NC/SCAR, and supplier audits to uphold quality across the supply network. The role requires 2–4 years in GMP/ISO environments, strong communication and problem-solving skills, and experience in medical

Qualifikationen

• Bachelor's or equivalent university degree is required; A concentration in Engineering, Life Science, or related field is preferred.
• Required: A minimum of 2-4 years of experience in a GMP and/or ISO regulated industry
• Strong communication, teamwork, and problem-solving 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
• Fluency (oral & written) in English is required
• Up to 10% travel may be required
• Six Sigma, Lean, or ASQ Certification and professional licenses preferred.

Aufgaben

• 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.

Kenntnisse

Root cause analysis

Communication

Teamwork

Problem solving

Analytical thinking

Verbal & written communication

English fluency

Learning ability

Ability to work under pressure

Stress management

Ausbildung

Bachelor's degree in Engineering/Life Science/related field

Jobbeschreibung

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 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 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.

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.

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.

The anticipated base pay range for this position is : $79,000.00 - $127,650.00 Additional Description for Pay Transparency: 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.

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 https://www.jnj.com/.