QUALITY ENGINEER II, POST MARKET SURVEILLANCE

Johnson & Johnson is currently seeking a  Quality Engineer II, Post Market Surveillance to join our  Abiomed  Team located in Danvers, MA or Irvine, CA.
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.
nj.
om/ For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.
Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world.
Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve.
Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential.
At Johnson & Johnson, we all belong.
This role reports directly to the Manager, Post Market Surveillance and engages in all activities related to the Abiomed post market surveillance processes.
This role will help build annual reports, enable signal detection, analyze complaint data trending, and raise trends or issues as needed in accordance with procedural guidance.
This individual will present post market data in any forums as necessary (data review board, complaint trending meetings, etc.) This role will also provide support during inspections by regulatory bodies and ensure appropriate post market surveillance information is available and fit for delivery to the front room.
Key Responsibilities.
Domain expert accountable for Abiomed Post Market Surveillance (PMS) activities including leading discussions and communicating PMS data in any required forums.
Creates and presents post market surveillance data for management review.
Participates in multi-functional and global teams to implement post market surveillance activities.
Collaborates with multi-functional partners to investigate relationships between key risk factors, medication, and procedural information and adverse events/complaint rates.
Collaborates with multi-functional partners to build factual annual reports and other post market surveillance activities when such activities are required as part of the post market surveillance commitments.
Stays on top of current trends in literature and research pertaining to data analysis for complaints / adverse event data.
Ensures compliance with QSR, MDV, MDR, MPR, and any applicable country regulations and requirements regarding post market surveillance trending.
Support additional information requests from global regulatory agencies.
Working knowledge of FDA Medical Device Regulations including Quality System Regulation 21 CFR Part 820, and applicable international quality standards including ISO , Canadian MDR, EU MDR and country specific vigilance related regulations.
Strong analytical skills including trend and statistical analysis, interpersonal, and leadership skills.
Qualifications Education.
A minimum of Bachelor’s degree is required Experience and Skills.
Required.
A minimum of 4 years’ experience in medical devices specifically related to post market surveillance.
Must be able to work independently, and demonstrate a high level of reliability, integrity, and personal accountability.
Must have excellent written and verbal communication skills and have a strong solid understanding of the development, application, and measurement of quality performance metrics.
Preferred.
Experience with fulfilling requests from internal and external audits is helpful.
Statistical knowledge and understanding.
Proven successful project management.
Solid understanding and experience in quality management of medical devices to maintain compliance with 21 CFR CFR 806, ISO & , EU MDR.
Demonstrated ability to create accurate and factual post market surveillance documentation consistent with applicable quality standards.
Other.
This role is based in Danvers, MA or Irvine, CA.
Ability to travel 10% domestically and internationally.
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.
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The base compensation for the role is between $.
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.
  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)).    This position is eligible to participate in the Company’s long-term incentive program.
  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              For additional general information on Company benefits, please go to.
-  https://www.
areers.
nj.
om/employee-benefits     This job posting is anticipated to close on .
The Company may however extend this time-period, in which case the posting will remain available on  https://www.
areers.
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om  to accept additional applications.