Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people.

With $76.5 billion in 2017 sales, Johnson & Johnson is the world's most comprehensive and broadly-based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. There are more than 250 Johnson & Johnson operating companies employing over 125,000 people and with products touching the lives of over a billion people every day, throughout the world. If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

COMPANY/GROUP OVERVIEW

Medical Devices & Diagnostics Global Services, LLC., represents more than 60 manufacturing sites and 26,000 employees who plan, source, manufacture and deliver high-quality and cost-effective medical products to our customers around the globe each day.  Work of the MD&D Supply Chain supports a multitude of product platforms, new products and delivery systems that are used in a wide range of procedures throughout the healthcare industry, including interventional cardiology, electrophysiology, minimally invasive surgery, hospital sterilization, clinical laboratory testing, diabetes management, joint replacement surgery and vision care.

POSITION OVERVIEW

The Associate Quality Engineer under general supervision conducts assignments involving a specific phase of an engineering project which may include design, development, manufacturing, construction, installation, operation and maintenance.  The incumbent may assist in determining objectives and planning schedules of multiple projects with few complex features.

The Associate Quality Engineer will utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. The incumbent will also utilize Quality Engineering principles and problem solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes.  This person will support processes in base business.

MAJOR RESPONSIBILITIES & DUTIES:

BUSINESS IMPROVEMENTS

• Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
• Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
• Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.

COMPLIANCE/REGULATORY

• Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.
• Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
• Conduct periodic line audits to assess for production controls such as lot segregation.  Review results of area audits to ensure that corrective and preventive actions are adequate.

NEW PRODUCT/PROCESS INTRODUCTION

• Supports new product introduction as part of design transfer.

PRODUCT QUALITY, CONTROL & DISPOSITION AND PERFORMANCE STANDARDS

• Supports activities related to the Material Review Board. 
• Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints.  Escalation of quality issues as appropriate.
• Review root cause investigation according to an established process.
• Support the collection/presentation of Quality metrics including leading and lagging indicators of quality

PRODUCT/PROCESS QUALIFICATION

• Support IQ, OQ, PQ, TMV or Software Validation

PRODUCTION/PROCESS CONTROLS INCLUDING CONTROL PLANS

• Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support. 
• Working in conjunction with other senior Quality Engineers, reviews effectiveness of current control plans given risk levels.
• Working in conjunction with other senior Quality Engineers, reviews the level of control in manufacturing processes including the adequacy of current process limits.

RISK MITIGATION

• Working in conjunction with other senior Quality Engineers, assess the current risk mitigation techniques implemented and whether these are consistent with the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.

QUALIFICATIONS

• A minimum of a Bachelors Degree, preferably in Engineering or related technical field. Generally requires 0-2 years related experience. 
• Experience working in both an FDA and European regulatory environment is preferred.
• This position will require relevant experience working in manufacturing/operations. 
• Knowledge of product/process Risk Management (FDA and ISO standards) is required.
• Experience with implementation of risk mitigation is preferred.
• Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc. 
• Knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.
• The ability to perform "hands on" troubleshooting and problem solving is preferred.  The ability to think on the feet and providing sound judgment is highly desired.
• Good technical understanding of manufacturing equipment and processes is required.
• Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
• A thorough understanding of GMP/ISO regulations and validation regulations is preferred.

LOCATION

• This position will be based in an MD&D manufacturing facility.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.