Job Function: Quality
Job Sub Function: R&D/Scientific Quality
Job Category:Professional
All Job Posting Locations:Raynham, Massachusetts, United States of America
Job Description: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.
DUTIES & RESPONSIBILITIESThe Staff NPD quality engineer will be responsible for the following, but not limited to:
- 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.
Additional Duties:
- 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
EXPERIENCE AND EDUCATION- 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.
- Experience with technical mentorship or managing co-ops/contractors preferred.
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS- 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
Required Skills:Preferred Skills: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 Control Testing, Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Researching
The anticipated base pay range for this position is :$109,000.00 - $174,800.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, 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.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
