Senior Supplier Quality Engineer - MedTech Quality Leader

6029-MEDICAL DEVICE BUSINESS SERVICES, INC. Legal Entity; Monet (FL); On-site; USD 79,000 - 128,000; Full time

Job summary

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

Qualifications

• 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.

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.

Skills

Root cause analysis

Communication

Teamwork

Problem solving

Analytical thinking

Verbal & written communication

English fluency

Learning ability

Ability to work under pressure

Stress management

Education

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

Job description

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