Job Information
J&J Family of Companies Staff Quality Engineer, PMS (Post Market Surveillance) in Raynham, Massachusetts
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:
Quality
Job Sub Function:
Customer/Commercial Quality
Job Category:
Professional
All Job Posting Locations:
US014 MA Raynham - 325 Paramount Dr, Warsaw, Indiana, United States of America, West Chester, Pennsylvania, United States of America
Job Description:
Johnson & Johnson is currently recruiting for a Staff Quality Engineer, PMS (Post Market Surveillance)! This position can be located in Raynham, MA, Warsaw, IN or West Chester, PA, with a preference for Raynham, MA.
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. As the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.
Position Summary:
The Staff PMS Quality Engineer will utilize Leadership, People Development, Interdependent Partnering, and Quality Engineering expertise to ensure efficient and effective Quality/Compliance and continuous improvement in the JnJ MedTech (DePuy Synthes) Post Market Surveillance space.
The role has responsibility for leading a team within the post market surveillance program in support of multiple lines/products with an emphasis on complaint trending, signal detection, data management and data analysis processes.
Supports product platforms in General Surgical Devices and MedTech Orthopedics implants and instrumentation.
Key Responsibilities:
Responsible for leading and contributing to a team of statisticians, engineers and analysts in support of post market surveillance signal detection as well as plans and reports.
Maintains data analysis methods, processes, tools, and capabilities.
Presents results and proposes corrective and preventive actions as required.
Uses team knowledge and processes to improve company products and processes.
Ensures appropriate training for associates.
Reviews and continuously leads efforts to improve global post market surveillance processes.
Responsible for driving rigorous data analysis including trending of specific complaint rates over time, part usage, and adverse event rates. Responsible for summarizing trends and signals, and escalating as required.
Continually optimizes data analysis techniques and tools to advance capabilities and efficiency while striving to drive consistency across businesses.
Ensures support of appropriate post market surveillance related submissions and reports to regulatory agencies worldwide in accordance with Quality System procedures.
Supports CAPA, Compliance, Quality and Business Objectives through completion of ad-hoc post market data analysis projects and queries.
Provides support during external and internal audits of the customer quality process. Remains informed of new or revised regulations and/or guidelines, and assesses impact on company product analysis processes.
Responsible for communicating business related issues or opportunities to next management level.
Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
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:
Education:
A minimum of a Bachelors or equivalent University degree is required with a focus in Engineering or related technical field (for example, Data Science, Biostatistics, Epidemiology, Public Health, Quality Engineering, Biomedical Engineering, Computer Science, Biology, etc. preferred.
Required:
A minimum of 6 years of related work experience.
Experience working in both an FDA and European regulated Medical Device environment.
Relevant experience in Quality Assurance within Medical Device, Diagnostic, Pharmaceutical or other regulated industry.
In-depth knowledge of product/process Risk Management (FDA and ISO standards).
Experience working in both an FDA and European regulated Medical Device environment.
Relevant experience working in manufacturing/operations.
Solid technical understanding of manufacturing equipment and processes.
Strong technical writing skills including validation protocols/reports experience.
Preferred:
Experience implementing appropriate risk mitigation.
Technical experience using Statistics including Measurement System Analysis (MSA) and Statistical Process Control (SPC).
Strong knowledge of statistical software packages and the ability to review, graph, analyze, and present data to facilitate/drive decision-making.
Ability to perform hands-on troubleshooting and problem solving.
Understanding of the NPI (New Product Introduction) process, Process Validation, and Computer Systems Validations (CSV).
Thorough understanding of GMP/ISO regulations and validation requirements is preferred.
Project management/leadership experience or certification.
Training or certification in Lean or Six Sigma Methodologies.
Experience using Change Management Techniques
Other:
This position may require up to 10% domestic travel.
The anticipated base pay range for this position is $91,000 to $147,200.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits:
Vacation – up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
Holiday pay, including Floating Holidays – up to 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
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 .
The anticipated base pay range for this position is :
91,000- 147,200 $USD
Additional Description for Pay Transparency:
• The anticipated base pay range for this position is $91,000 to $147,200. • Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. • Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). • Employees are eligible for the following time off benefits: • Vacation – up to 120 hours per calendar year • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year • Holiday pay, including Floating Holidays – up to 13 days per calendar year • Work, Personal and Family Time - up to 40 hours per calendar year The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.