At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at
Job Function:
Supply Chain EngineeringJob Sub Function:
Quality EngineeringJob Category:
Scientific/TechnologyAll Job Posting Locations:
Palm Beach Gardens Florida United States of AmericaJob 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.
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.
Education:
University/Bachelors or equivalent degree in Engineering Life Science or related field is required.
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.
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
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 .
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 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 SavvyThe anticipated base pay range for this position is :
$94000.00 - $151800.00Additional 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.Staff IC
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more