Senior NPD Quality Engineer

Johnson & Johnson MedTech; Raynham (MA); On-site; USD 92,000 - 148,000; Full time

Benefits offered by this job

Vacation 120 hours/yr

Sick time 40 hours/yr

Floating holidays

Job summary

Johnson & Johnson in Raynham, MA is seeking a Senior New Product Development Quality Engineer to lead quality activities on new product development projects. You will own risk management, Design Verification and Validation strategies, and Design Transfer to Manufacturing for the Mitek Sports Medicine product portfolio.

The role requires a bachelor’s degree in engineering, at least 4 years in regulated quality or NPD, strong knowledge of GD&T, Six Sigma/Lean, and excellent communication to

Qualifications

• Bachelor's degree in Engineering or related field.
• 4+ years regulated industry experience in quality/NPD.
• Strong knowledge of Quality Engineering methods & GD&T.
• Experience with FDA/European regulatory environments preferred.

Responsibilities

• Lead new product development quality activities across projects.
• Apply Six Sigma and Lean to introduce or improve products/processes.
• Lead risk management and mitigation activities.
• Lead root cause investigations and assess corrective actions.
• Develop test methods for equipment, process, and product qualifications/ validations.
• Ensure process quality control plans align with product risk levels.

Skills

Quality Eng

Lean Six Sigma

Risk Management

GD&T

Project Leadership

Education

Bachelor's in Engineering or related field

4+ years regulated industry experience

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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 Senior 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. This role is for our Mitek Sports Medicine organization supporting our soft tissue solution portfolio of products.

Duties & Responsibilities

• Independently provide directions and oversight of the new product development quality activities across assigned projects.
• Apply various tools and methods (for example, Six Sigma, Lean) to identify and realize new product or process introductions as well as process improvements.
• Apply various risk management and risk mitigation tools and practices, for example, mistake proofing, critical control points, failure mode and effects analysis.
• Supports the reliability assessments of product design.
• Lead root cause investigations using various problem-solving techniques and tools and assess effectiveness of corrective actions.
• Conducts, and supports the development of, test methods in equipment, process, and product qualifications/validations.
• Ensures that process Quality control plans are in accordance with product risk level and are consistently followed.
• Implements and/or maintains, production and process controls using appropriate techniques (for example, process capability measures, statistical process controls, and process performance metrics).
• Participate in technical reviews as appropriate.
  

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

• A minimum of a Bachelor's degree is required. Degrees in Engineering or related technical/scientific field is preferred.
• A minimum of 4 years of regulated industry experience in quality, new product development, or manufacturing engineering capacity is required.
• Strong knowledge of Quality Engineering/Scientific methods and techniques.
• Strong knowledge of GD&T and inspection methodologies.
• Experience with a proven track record of implementing appropriate risk mitigation.
• Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
• Experience handling tasks or small projects and demonstrating project leadership abilities.
• Strong communication skills and teamwork skills to support partnering cross functionally.
  

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 both an FDA and European regulatory environment is preferred.
  

Required Skills
Preferred Skills:
Agility Jumps, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Database Backup, Data Savvy, Disruptive Innovations, Issue Escalation, Problem Solving, Process Oriented, Product Improvements, Quality Control (QC), Quality Control Testing, Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing

The anticipated base pay range for this position is :
$92,000.00 - $148,350.00

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.

Benefits
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