Johnson & Johnson MedTech · 8 hours ago
Staff NPD Quality Engineer
Raynham, MA
Full-time
Onsite
Senior Level, Lead/Staff
$109K/yr - $175K/yr
6+ years expJohnson & Johnson is a leader in healthcare innovation, and they are seeking a Staff New Product Development Quality Engineer for their Joint Reconstruction Platform. This role involves leading quality engineering efforts on new product development projects and ensuring compliance with medical device regulations while mentoring team members.
Hospital & Health Care
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
Qualification
Required
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
Preferred
Experience with technical mentorship or managing co-ops/contractors preferred
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
Company
Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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