Staff Quality Engineer

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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 https://www.jnj.com

Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Palm Beach Gardens, Florida, United States of America

Job Description:

Johnson & Johnson is recruiting for a Staff Quality Engineer, located in Palm Beach Gardens, FL.

The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.

Our rapidly growing Velys Enabling Tech Operation is in need of a Staff Quality Engineer who provides overall quality assurance leadership of on-site manufacturing areas. Ensures manufacturing areas are meeting good manufacturing practices, international organization for standardization and any other applicable standards. This position is focused on the support of New Product Introduction and Value Improvement projects implementation to the PBG Site.

Key Responsibilities:

• Develops standard operating procedures, specifications, and provides technical transfer and validation support.

• Minimizes sample and scrap waste, assesses reliability and risks based on validated data, identifies root causes of problems, and reduces or eliminates sources of variation.

• Audits and approves manufacturing, quality, engineering and validation documents for conformance to business practices and departmental procedures.

• Provides data and documentation in support of the development of validation strategies.  Acts as liaison to the regulatory affairs department to perform initial regulatory review of all

  engineering changes and modifications to products.

• Provides sampling plans and approves inspection methods for evaluation and testing of components and products.

• Provides support and expertise in reliability planning and reliability growth demonstration during new product development.

Qualifications

Education:

• University/Bachelor's or equivalent degree in Engineering, Life Science, or related field is required.

Experience and Skills:

Required:

• A minimum of six (6+) years of related work experience.

• Experience working in regulated industries

• Professional quality or Manufacturing Engineering experience.

• In-depth knowledge of product/process Risk Management (MDSAP, MDD, MDR, FDA and ISO standards)

• Experience and a proven track record of implementing appropriate risk mitigation

• Strong communication, teamwork, problem solving and decision-making skills

• Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC,

  DOEs, Reliability, etc.

• Ability to perform "hands on"

  troubleshooting and problem solving.

• Strong mentoring, coaching and leadership skills

• Demonstrated project management and project leadership abilities

• Experience in process quality and validation.

Preferred:

• Strong knowledge of statistical software packages with the ability to preview, graph and analyze data and be

  able to present data that facilitates/drives decision making.

• Understanding of the NPI (New Product

  Introduction) process

Other:

• This position will require less than 10% travel

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

 

 

Preferred Skills:

Coaching, Consistency, Controls Compliance, Critical Thinking, Data Savvy, Engineering, Financial Competence, Good Automated Manufacturing Practice (GAMP), ISO 9001, Lean Supply Chain Management, Leverages Information, Process Improvements, Quality Control (QC), Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Technologically Savvy

 

 

The anticipated base pay range for this position is :

$94,000.00 - $151,800.00

Additional Description for Pay Transparency:

Please provide the benefits applicable. Required for US Positions. Please copy and paste the applicable benefits into the empty text box below, based on the type of role.

[DELETE ANY BENEFITS NOT APPLICABLE TO THE POSITION]



Please use the following language:



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