Sr. Supplier Quality Engineer

Johnson & Johnson Innovative Medicine

2d•$79,000 - $127,650

About The Position

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes. DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. 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 Johnson and Johnson products. Works collaboratively with management to drive decisions regarding Quality Engineering methods to produce leading-edge customer-tailored engineering final deliverables.

Requirements

Bachelor's Degree is required
Generally, requires 5-7 years of work experience in a GMP and/or ISO regulated industry
Engineering or science field of study is preferred
Strong communication, teamwork, and problem-solving skills are required
Ability to work in stressful/fast-paced environment
Ability to work and interact with co-workers to accomplish company goals in a team environment
Management Skills
Analytical/Problem Solving Skills
Ability to communicate verbally and in writing
Ability to learn

Nice To Haves

Experience in the medical device / pharmaceutical industry is preferred
Experience in machining, injection molding and/or electronics assembly is preferred
FDA CFR Part 820 and/or ISO 13485 knowledge is preferred
Six Sigma, Lean, American Society for Quality (ASQ) certification and professional licenses are preferred
Fluency in English is a must

Responsibilities

Implement SQ strategy and follow Supplier Quality standards
Manage Supplier related Non-Conformities (NC and SCAR's) and Corrective and Preventive Actions (internal CAPA's
Oversee supplier change requests (SCR) with Procurement
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 SCAR internal CAPA
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
Prepare regular report and supplier quality metrics
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.
For those who supervise or manage a staff, 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
Performs other duties assigned as needed

Benefits

employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
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