Zuchwil, Solothurn, Switzerland · Hybrid
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 in…
Skills: Design Quality Engineering, Risk Management, Validation, Statistical Methods, Root Cause Analysis
Schaffhausen, Schaffhausen, Switzerland · On-site
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 in…
Skills: Analytical Reasoning, Computerized Equipment Skills, Corrective and Preventive Action (CAPA), Emerging Technologies, Execution Focus
Shanghai, Shanghai, China · On-site
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 in…
Skills: Analytical Reasoning, Business Behavior, Business Data Analysis, Coaching, Communication
Hyderabad, Andhra Pradesh, India · Hybrid
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 in…
Skills: Advanced Analytics, Biostatistics, Clinical Data Management, Clinical Operations, Cross-Functional Collaboration
Zagreb, Grad Zagreb, Croatia · Hybrid
$57k–$129k/yr
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 in…
Skills: Account Management, Business Model Innovation, Client Management, Commercial Awareness, Commercial Management
Babergh, England, United Kingdom · Hybrid
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 in…
Skills: Agility Jumps, Analytics Insights, Business Alignment, Collaboration Tools, Communication
Ciudad Juarez, Chihuahua, Mexico · On-site
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 in…
Skills: Equipment Design, Material Testing, Process Improvement, Specification Management, Project Management
Beerse, Flanders, Belgium · Hybrid
$60k–$96k/yr
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 in…
Skills: Agility Jumps, Analytics Insights, Business Alignment, Collaboration Tools, Communication
Jacksonville, Florida, United States · Hybrid
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 in…
Skills: Business Alignment, Business Savvy, Coaching, Communication, Compliance Management
Toronto, Ontario, Canada · Hybrid
$74k–$120k/yr
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 in…
Skills: Agility Jumps, Analytics Insights, Business Alignment, Collaboration Tools, Communication
Taguig, Metro Manila, Philippines · Hybrid
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 in…
Skills: Accounting, Accounting Policies, Analytical Reasoning, Billing Operations, Budgeting
Singapore, Singapore · On-site
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 in…
Skills: Analytical Reasoning, Benchmarking, Consulting, Demand Forecasting, Distribution Management
Zuchwil, Solothurn, Switzerland · On-site
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 in…
Skills: Account Management, Collaboration, Compliance Management, Customer Centricity, Execution Focus
Bogota, Capital District, RAP (Especial) Central, Colombia · Hybrid
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 in…
Skills: Revenue Recognition, General Accounting, SAP, Team Leadership, IFRS
Gurabo, Puerto Rico, United States · On-site
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 in…
Skills: Manufacturing Science & Technology, Process Validation, Solid Oral Dosage, Change Control, Root Cause Analysis
Raritan, New Jersey, United States · Hybrid
$164k–$283k/yr
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 in…
Skills: Indirect Treatment Comparisons, Real-World Evidence, Causal Inference, Biostatistics, Epidemiology
Palm Beach Gardens, Florida, United States · Hybrid
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 in…
Skills: Agility Jumps, Commercial Awareness, Competitive Landscape Analysis, Cross-Functional Collaboration, Customer Intelligence
São Paulo, São Paulo, Brazil · Hybrid
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 in…
Skills: Pricing Strategy, Contract Management, Commercial Operations, Revenue Management, Distributor Management
Kunming, Yunnan, China · On-site
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 in…
Skills: Business Behavior, Communication, Consulting, Cross-Selling, Customer Centricity
Vienna, Austria · Hybrid
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 in…
Skills: Health Economics, Market Access, HTA, Strategic Planning, Project Management
Zuchwil, Solothurn, Switzerland • Hybrid
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Develop standard operating procedures and provide technical transfer and validation support for orthopedic implants and instrumentation. Lead design and development planning, conduct technical reviews, and manage risk throughout the product life cycle.
Requires a B.S. in Engineering or Technical Science and at least one year of experience in a GMP or ISO regulated industry. Preferred qualifications include knowledge of QSR, ISO 13485, and experience in medical device new product development.
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 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:
QualityJob Sub Function:
R&D/Scientific QualityDevelops 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.
Support the New Product Development Design Quality Group for the TECA business, mainly for launching orthopedic implants and associated instrumentation.
Significant contributor to a multi-discipline team in all aspects of the Quality System and provides overall quality assurance leadership in the management of selected contract manufacturing sites engaged in the production of DePuy Synthes products.
Supports the selected contract manufacturing sites in validation, risk management, product quality issue resolution and escalation, and quality systems performance monitoring for new product development introduction at the manufacturing sites.
Product development team member focused on product development and life cycle management activities related to the Trauma/CMF business.
Lead design and development planning activities for new projects.
Participate in all aspects of the creation and execution of functional/design requirements for new projects.
Conduct formal technical design reviews throughout the phases of the product development process.
Support and approve design verification/validation activities including mechanical testing, tolerance analyses, design rationales, and surgeon based anatomical labs.
Apply statistical methods and design excellence tools to design verification and validation activities.
Support risk management activities including planning, design & clinical risk management, production risk management, and overall risk benefit reporting.
Lead the cascade of critical to quality design features to product quality plans and downstream manufacturing & quality processes.
Support transfer to manufacturing activities both in product development and base businesses.
Support product life cycle management activities such as design changes and cost improvement initiatives.
Enhance the design control and risk management processes to better reflect state of the art practices and drive continuous improvement.
Provide support in all areas of the Quality System, including, but not limited to corrective & preventive actions, product complaints, post market surveillance, nonconforming materials, risk management, and audit support functions.
Understanding of medical device regulations to other disciplines.
Work closely with suppliers on the qualification of new parts and processes supporting product development.
Communicate effectively at all levels within Quality, as well as cross functionally with departments such as Product Development, Regulatory, Manufacturing, and Marketing.
Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics, and compliance at all times.
Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
Responsible for communicating business related issues or opportunities to next management level.
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.
Performs other duties assigned as needed.
Qualifications/Requirements:
Education: B.S. in Engineering and/or in a Technical Science
Minimum of 1 year experience in a GMP and/or ISO regulated industry is required (internships, co-ops, practical experience).
New product development experience or previous experience in a medical device or a healthcare discipline is preferred.
Preferred:
Working knowledge of QSR (21 CFR 820) and ISO (13485, 14971) quality requirements is preferred.
Blueprint literacy including GD&T preferred.
Knowledge of process and design excellence tools is strongly preferred. Certification is a plus.
Excellent problem solving, decision-making, and root cause analysis skills.
Interpersonal skills that foster conflict resolution as it relates to technical situations.
Embrace teamwork, change, risk-based decision making and flexibility.
Self-motivated to take action.
Have excellent written and verbal communication skills.
New product development experience or previous experience in a medical device or a healthcare discipline is preferred.
At Johnson & Johnson Innovative Medicine, we innovate with purpose, to lead where medicine is going. The experiences of patients around the world inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science with compassion, we confidently address the most complex diseases of our time and develop the potential medicines of tomorrow. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way. https://bit.ly/3reuMvK
View all jobs at Johnson & Johnson Innovative MedicineAt Johnson & Johnson Innovative Medicine, we innovate with purpose, to lead where medicine is going. The experiences of patients around the world inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science with compassion, we confidently address the most complex diseases of our time and develop the potential medicines of tomorrow. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way. https://bit.ly/3reuMvK
View all jobs at Johnson & Johnson Innovative Medicine