Staff NPD Quality Engineer

Johnson & Johnson Innovative Medicine • Raynham, MA

1d • $109,000 - $174,800 • Onsite

About The Position

The Staff New Product Development (NPD) Quality Engineer provides Quality Engineering leadership on new product development projects in the areas of Design Controls and Design Transfer to Manufacturing including, but not limited to: Risk Management, Design Verification and Validation Strategies, and Design Transfer to Manufacturing. The Staff engineer operates at a high level of independence and has strong competency with problem solving and escalation pathways. This role is for our Joint Reconstruction organization supporting our Shoulder Reconstruction portfolio of products.

Requirements

• Bachelor’s degree in Engineering or related technical/scientific field AND 6 or more years related experience.
• Understanding of new product introduction processes, and expertise in process qualifications/validations.
• Strong knowledge of GD&T and inspection methodologies.
• Experience implementing appropriate risk mitigation with knowledge of product and process Risk Management (FDA & ISO standards).
• 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.
• Ability to effectively collaborate and communicate with internal and external partners and demonstrate strong interpersonal, organizational, and verbal/written communications skills.
• Experience working in a regulated environment. This includes knowledge of, and experience with, applicable standards, GxP requirements and regulations.

Nice To Haves

• Experience with technical mentorship or managing co-ops/contractors preferred.

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 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.
• 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 personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

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

What This Job Offers

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