Staff NPD Quality Engineer

Johnson & Johnson Innovative Medicine•Raynham, MA

1d•$109,000 - $174,800

About The Position

Johnson & Johnson is recruiting for a Staff New Product Development Quality Engineer for our Joint Reconstruction Platform supporting Shoulder Reconstruction. This position is located in Raynham, MA. 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.

Requirements

Bachelor’s degree in Engineering or related technical/scientific field AND 6 or more years related experience.
Advanced knowledge of Quality Engineering/Scientific Method techniques and principles.
Demonstrates a strong understanding of all areas of the Quality System, including, but not limited to corrective & preventive actions, product complaints, post market surveillance, nonconformances, risk management, and audit.
Familiarity with manufacturing processes and controls.
Understanding of new product introduction processes, and expertise in process qualifications/validations.
Experience implementing appropriate risk mitigation with knowledge of product and process Risk Management (FDA & ISO standards).
Experience working in a regulated environment. This includes knowledge of, and experience with, applicable standards, GxP requirements and regulations
Leadership

Nice To Haves

Experience with technical mentorship or managing co-ops/contractors preferred.
Accelerating
Agility Jumps
Coaching
Communication
Compliance Management
Continuous Improvement
Data Savvy
Disaster Recovery (DR)
Econometric Models
Issue Escalation
Problem Solving
Product Improvements
Quality Control (QC)
Quality Management Systems (QMS)
Quality Standards
Regulatory Environment
Researching

Responsibilities

Serve as lead quality engineer on cross functional new product development projects.
Leads design transfer activities with internal and external (suppliers) stakeholders.
Leverage technical competency in key core competency areas including but not limited to statistical techniques, GD&T, inspection methodologies, and process validations to support new product introduction.
Leads, and/or contributes to, root cause investigations using various problem solving techniques and tools.
Provide leadership in all areas of the Quality System, including, but not limited to corrective & preventive actions, product complaints, post market surveillance, nonconformances, risk management, and audits.
Provide leadership in the understanding of medical device regulations to other disciplines.
Communicates effectively at all levels within Quality, as well as cross functionally with departments such as Product Development, Regulatory, Supply Chain, and Marketing.
Mentors others in various technical capabilities.

Benefits

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