Supplier Quality Engineer II

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Description

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
  
  

Qualifications

• Bachelor’s degree required in a related Engineering discipline
• 2 years of experience in QA/QE in the medical device field is required
• Experience with manufacturing of complex products in an ECA, ideally catheter-based or cardiac assist devices is preferred
• Manufacturing and supplier quality control experience is required
• Experience with formal problem-solving methodologies and deductive skills are preferred
• Good understanding of FDA QSRs, ISO13485, Ordinance 169, ISO14971 is required
• Experience with handling non-conforming material and assemblies; including root cause investigations pertaining to such non-conformities is required
• Experienced in qualification of production equipment and verification of production processes is preferred
• Experience supporting internal and supplier audits of manufacturing processes is required
• Utilized statistical data analysis for trending purposes; ideally utilized Six Sigma methods and tools are preferred
• Experience with SAP or other ERP system is a plus
• Willingness to travel, particularly to visit suppliers (10% required)
  
  

The base compensation for the role is between $76,000-$121,900. 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)).

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.careers.jnj.com/employee-benefits

This job posting is anticipated to close on 8/16/24. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.