Supplier Quality Engineer II

Johnson & Johnson is currently seeking a Supplier Quality Engineer II to be located in Halethorpe, MD to join our Abiomed Team.

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.

The Supplier Quality Engineer II is responsible for cross-functional Quality Assurance, Quality Management/Compliance and activities associated with all Abiomed products and processes with a focus on supplier for the Baltimore Site.

Primary Duties and Responsibilities:

• Provide quality engineering support in the development and manufacturing of new and existing disposable medical devices.

• Lead Auditor for all external supplier audits and ensure audit schedule is developed and followed

• Lead analysis of defective components found in Incoming Inspection and work with suppliers to resolve (SCARs)

• Lead/support the supplier evaluation process when selecting & qualifying new suppliers; help maintain the ASL, supplier scorecards, and supporting documentation required per SOPs

• Resolve incoming inspection yield issues by driving tighter vendor process capabilities and ensuring appropriate internal drawing tolerances

• Ensure compliance of manufacturing processes and areas to all applicable quality system regulations

• Monitor and analyze production information to support risk management and to provide direction for corrective and preventive actions and/or process improvement activities (CAPA)

• Validate manufacturing and supplier processes, including activities associated with equipment installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ)

• Work with manufacturing engineering and supply chain to ensure necessary process controls and validations are in place and best practices are followed (GMP)

• Identify key process input variables and key process output variables

• Support Quality Management System (process development, creating and editing new and existing SOPs). Support internal auditing requirements in manufacturing

• Other duties as assigned by the manager