Johnson & Johnson MedTech
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 R&D Product Development
Job Sub Function Biomedical Engineering
Job Category Scientific/Technology
Locations Cincinnati, Ohio, United States of America; Danvers, Massachusetts, United States of America; Irvine, California, United States of America; Raritan, New Jersey, United States of America
Job Description J&J MedTech is recruiting for a Senior Quality Engineer located in Cincinnati, OH.
Role Overview The Senior Quality Engineer applies the principles of engineering, mathematics, statistics, organizational excellence, and risk management to help the company achieve two major objectives in support of the J&J Credo:
Meet and exceed the expectations of our customers
Achieve and maintain compliance with regulatory expectations
The Senior Quality Engineer provides overall quality assurance leadership in the management of select contract manufacturing sites engaged in the production of Johnson & Johnson products, and ensures compliance to Good Manufacturing Practices, ISO, and any other applicable standards. Depending on job needs, the Senior Quality Engineer may work in:
New product development / new product introduction / new process introduction
Supply chain (life cycle engineering, manufacturing, assembly, or supplier quality)
Quality systems and business processes
Key Job Responsibilities
Provides leadership in design and implementation of world‑class quality engineering to support the entire product life cycle with focus on quality engineering activities such as reliability, risk management, analytics/statistical techniques, requirements management, verification & validation, and design control across the lifecycle of the product.
Provides complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes; acts as technical liaison, as needed, between product development, manufacturing, external manufacturers, and suppliers.
Reviews and edits all engineering documentation related to assigned projects, such as technical reports, work instructions and method and process validation; provides review and approval for the release of new products and design changes ensuring quality requirements are met.
Applies intermediate Quality Engineering/Scientific Method techniques and principles to daily tasks and activities. In addition, applies relevant regulations, standards, and industry best practices to assignments.
Plans and conducts projects and assignments with technical responsibility or strategic input. Receives intermittent, moderately detailed instructions from technical Quality leaders at various levels, in addition to other stakeholders.
Addresses and corrects product and process complaints through data analysis, continuous product improvement, and/or corrective and preventive actions.
Communicates business related issues or opportunities to next management level.
Oversees audits of quality system categories to assess compliance to process excellence standards.
Ensures comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management which outline findings.
Performs and/or oversees complex hands‑on and simulated testing for design verification and test method developments; inspects and oversees testing of prototypes, tools, and fixtures after fabrication to ensure that they meet specifications.
Studies specifications, engineering blueprints, tool orders, and shop data and confers with engineering and shop personnel to resolve design problems related to material characteristics, dimensional tolerances, service requirements, manufacturing procedures, and cost.
Ensures personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
Performs other duties assigned as needed.
May support technical training (i.e. statistics and quality methods) and teaching/mentoring of others.
Key Skill And Knowledge Requirements
Strong analytical problem‑solving skills and ability to contribute to or lead root cause investigations using various problem‑solving techniques and tools, and assess effectiveness of corrective actions.
Sound statistical application in areas such as DOE, sampling techniques, regression, reliability, FMEA, hypothesis testing, etc.
Experience with project management and the ability to work with multiple simultaneous priorities in a highly matrixed environment.
Demonstrated experience working within a team, obtaining feedback, negotiating, and positively influencing.
Ability to understand new concepts quickly, research and maintain ongoing learning of industry regulations.
Fundamental technical understanding of manufacturing equipment and processes, preferred.
Prior experience working with Risk Analysis and Risk Management, also preferred.
Advanced quality systems (AQS) experience preferred.
Knowledge of regulatory compliance, GMPs, MDD, 510K, PMA, and government, trade association, industry & medical publications desired.
Qualifications
bachelor’s degree in engineering from an accredited engineering or relevant science/technical school is required. A degree in Mechanical, Electrical, Biomedical or other equivalent technical degree is preferred.
Non‑STEM graduates with follow‑on technical training or experience will also be considered. Appropriate relevant advanced degrees are preferred.
Generally requires minimum of 4 years’ work experience. Experience in a regulated industry or veterans with leadership experience will be given preference.
Experience with Risk Management (ISO 14971), Medical Device Quality Management System (ISO 13485), Gage repeatability and reproducibility theory and application, statistics, project management (supporting multiple projects simultaneously), and reliability is strongly preferred.
Auditing skills such as ISO, QSR, MDSAP, and GMP standards are preferred.
ASQ certification (CQE, CQM, CRE or CQA) is an asset. Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is an asset.
This position will be located in Cincinnati, OH and may have up to 10% of both domestic and international travel.
Equal Opportunity Statement 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.
Required Skills
Problem Solving
Preferred Skills
Analytical Reasoning
Bioinformatics
Biological Engineering
Biological Sciences
Biostatistics
Coaching
Data Savvy
Detail‑Oriented
Feasibility Studies
Inventory Management
Preclinical Research
Project Schedule
Prototyping
Research and Development
Researching
SAP Product Lifecycle Management
Technologically Savvy
Pay Transparency Base pay range: $92,000.00 - $148,350.00
Benefits
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year (48 hours for Colorado residents, 56 hours for Washington residents)
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 period (10 days)
Volunteer Leave – 32 hours per calendar year
Military Spouse Time‑Off – 80 hours per calendar year
Additional general information on Company benefits:
https://www.careers.jnj.com/employee-benefits
#J-18808-Ljbffr
https://www.jnj.com
Job Function R&D Product Development
Job Sub Function Biomedical Engineering
Job Category Scientific/Technology
Locations Cincinnati, Ohio, United States of America; Danvers, Massachusetts, United States of America; Irvine, California, United States of America; Raritan, New Jersey, United States of America
Job Description J&J MedTech is recruiting for a Senior Quality Engineer located in Cincinnati, OH.
Role Overview The Senior Quality Engineer applies the principles of engineering, mathematics, statistics, organizational excellence, and risk management to help the company achieve two major objectives in support of the J&J Credo:
Meet and exceed the expectations of our customers
Achieve and maintain compliance with regulatory expectations
The Senior Quality Engineer provides overall quality assurance leadership in the management of select contract manufacturing sites engaged in the production of Johnson & Johnson products, and ensures compliance to Good Manufacturing Practices, ISO, and any other applicable standards. Depending on job needs, the Senior Quality Engineer may work in:
New product development / new product introduction / new process introduction
Supply chain (life cycle engineering, manufacturing, assembly, or supplier quality)
Quality systems and business processes
Key Job Responsibilities
Provides leadership in design and implementation of world‑class quality engineering to support the entire product life cycle with focus on quality engineering activities such as reliability, risk management, analytics/statistical techniques, requirements management, verification & validation, and design control across the lifecycle of the product.
Provides complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes; acts as technical liaison, as needed, between product development, manufacturing, external manufacturers, and suppliers.
Reviews and edits all engineering documentation related to assigned projects, such as technical reports, work instructions and method and process validation; provides review and approval for the release of new products and design changes ensuring quality requirements are met.
Applies intermediate Quality Engineering/Scientific Method techniques and principles to daily tasks and activities. In addition, applies relevant regulations, standards, and industry best practices to assignments.
Plans and conducts projects and assignments with technical responsibility or strategic input. Receives intermittent, moderately detailed instructions from technical Quality leaders at various levels, in addition to other stakeholders.
Addresses and corrects product and process complaints through data analysis, continuous product improvement, and/or corrective and preventive actions.
Communicates business related issues or opportunities to next management level.
Oversees audits of quality system categories to assess compliance to process excellence standards.
Ensures comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management which outline findings.
Performs and/or oversees complex hands‑on and simulated testing for design verification and test method developments; inspects and oversees testing of prototypes, tools, and fixtures after fabrication to ensure that they meet specifications.
Studies specifications, engineering blueprints, tool orders, and shop data and confers with engineering and shop personnel to resolve design problems related to material characteristics, dimensional tolerances, service requirements, manufacturing procedures, and cost.
Ensures personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
Performs other duties assigned as needed.
May support technical training (i.e. statistics and quality methods) and teaching/mentoring of others.
Key Skill And Knowledge Requirements
Strong analytical problem‑solving skills and ability to contribute to or lead root cause investigations using various problem‑solving techniques and tools, and assess effectiveness of corrective actions.
Sound statistical application in areas such as DOE, sampling techniques, regression, reliability, FMEA, hypothesis testing, etc.
Experience with project management and the ability to work with multiple simultaneous priorities in a highly matrixed environment.
Demonstrated experience working within a team, obtaining feedback, negotiating, and positively influencing.
Ability to understand new concepts quickly, research and maintain ongoing learning of industry regulations.
Fundamental technical understanding of manufacturing equipment and processes, preferred.
Prior experience working with Risk Analysis and Risk Management, also preferred.
Advanced quality systems (AQS) experience preferred.
Knowledge of regulatory compliance, GMPs, MDD, 510K, PMA, and government, trade association, industry & medical publications desired.
Qualifications
bachelor’s degree in engineering from an accredited engineering or relevant science/technical school is required. A degree in Mechanical, Electrical, Biomedical or other equivalent technical degree is preferred.
Non‑STEM graduates with follow‑on technical training or experience will also be considered. Appropriate relevant advanced degrees are preferred.
Generally requires minimum of 4 years’ work experience. Experience in a regulated industry or veterans with leadership experience will be given preference.
Experience with Risk Management (ISO 14971), Medical Device Quality Management System (ISO 13485), Gage repeatability and reproducibility theory and application, statistics, project management (supporting multiple projects simultaneously), and reliability is strongly preferred.
Auditing skills such as ISO, QSR, MDSAP, and GMP standards are preferred.
ASQ certification (CQE, CQM, CRE or CQA) is an asset. Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is an asset.
This position will be located in Cincinnati, OH and may have up to 10% of both domestic and international travel.
Equal Opportunity Statement 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.
Required Skills
Problem Solving
Preferred Skills
Analytical Reasoning
Bioinformatics
Biological Engineering
Biological Sciences
Biostatistics
Coaching
Data Savvy
Detail‑Oriented
Feasibility Studies
Inventory Management
Preclinical Research
Project Schedule
Prototyping
Research and Development
Researching
SAP Product Lifecycle Management
Technologically Savvy
Pay Transparency Base pay range: $92,000.00 - $148,350.00
Benefits
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year (48 hours for Colorado residents, 56 hours for Washington residents)
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 period (10 days)
Volunteer Leave – 32 hours per calendar year
Military Spouse Time‑Off – 80 hours per calendar year
Additional general information on Company benefits:
https://www.careers.jnj.com/employee-benefits
#J-18808-Ljbffr