Massachusetts Healthcare Jobs

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:

Raynham, Massachusetts, United States of America, 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 Senior Quality Engineer, PMS (Post Market Surveillance)! This position can be located in Raynham, MA, Warsaw, IN or West Chester, PA.

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 Sr. PMS Quality Engineer will generate and coordinate risk management, data analysis, and other activities within the Post Market Surveillance Department of DePuy Synthes. He/she will have responsibilities within DePuy Synthes (including but not limited to Spine, Mitek, and Joint Reconstruction) to drive and lead Post Market Surveillance activities at the highest level of quality and compliance independently.

• The Quality Engineer III - PMS role will perform post market safety and surveillance activities including trend analyses, signal assessments and product investigations. He/she will execute the Post Market Surveillance process with a primary focus on signal assessment and detailed investigations of potential Safety Issues and Quality Trend Events.

• This is a hands-on position that will require a self-motivated individual with excellent written and oral communication skills. This role will have the ability to collaborate with business partners at all levels with multiple functional groups in an environment that embraces teamwork and risk-based decision making.

• Supports product platforms in General Surgical Devices and MedTech Orthopedics implants and instrumentation.

Key Responsibilities:

• Executes the defined PMS process.

• Investigate and lead systematic collection of internal and external data on product safety and performance.

• Lead and facilitate cross-functional product reviews.

• Identify potential product performance issues early and escalate appropriately.

• Prepare PMS Plans as required per applicable procedures and regulations.

• Prepare reports on PMS related activities as required per PMS plan.

• Assist in developing and implementing continuous improvements within policies and procedures.

• DePuy Synthes job descriptions may be revised at management's discretion, at any time.

• Assist with DePuy Synthes Operating Companies Post Market Surveillance initiatives.

• Assist with CAPA activities as needed.

• 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.

• 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:

• Relevant experience in Quality Assurance within Medical Device, Diagnostic, Pharmaceutical or other regulated industry.

• A minimum of 4 years of related work experience.

• Excellent problem solving and decision making skills.

• Root cause analysis skills.

• Working knowledge of reading and interpreting product specifications

• Proficiency with the Microsoft Office Suite

Preferred:

• Experience with Post Market Surveillance/Safety Surveillance activities.

• Previous Design Control experience.

• Experience with statistics/analytics and programming languages

• Experience working in both an FDA and European regulated Medical Device environment

• Training or certification in Lean or Six Sigma Methodologies

Other:

• This position may require up to 10% domestic travel.

• The anticipated base pay range for this position is $77,000 to $124,200.

• 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 :

77,000- 124,200 USD$

Additional Description for Pay Transparency:

• The anticipated base pay range for this position is $77,000 to $124,200. • 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.