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.jnj.com/

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 13485:2013, Canadian MDR, EU MDR and country specific vigilance related regulations.
• Strong analytical skills including trend and statistical analysis, interpersonal, and leadership skills.