Sr Supplier Quality Engineer

6029-MEDICAL DEVICE BUSINESS SERVICES Legal Entity • Palm Beach Gardens, FL

1d • Onsite

About The Position

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.

Requirements

• 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
• Fluency (oral & written) in English is required

Nice To Haves

• 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
• 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

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 period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior