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:
Supplier Quality

Job Category:
Professional

All Job Posting Locations:
Danvers, Massachusetts, United States of America

Job Description:

Abiomed, part of Johnson & Johnson MedTech, is recruiting for a Supplier Quality Engineer II to be located in Danvers, MA.

About MedTech

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.

I Am Abiomed | I Am Heart Recovery | Patients First!

ABIOMED is redefining success while reshaping heart recovery. Here, new ideas are welcomed and encouraged, learning is constant, and our dynamic setting enables positive people to do profoundly important work.

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 Danvers plant. This role involves hands-on project management, collaboration with multi-functional teams, and ensuring that supplier qualification processes align with quality standards and company objectives.

Primary Duties and Responsibilities:

Develop and implement Supplier qualification plans, including risk assessments, quality audits, and performance evaluation
Establish and communicate clear quality standards and criteria for new suppliers
Collaborate with engineering and procurement teams to define specifications and expectations for supplier performance
Develop project plans outlining milestones, timelines, and resource requirements for new supplier qualification projects
Implement projects efficiently, ensuring alignment with overall business objectives and project deliverables
Work closely with multi-functional teams, including procurement, Design engineering, manufacturing and sourcing to align project goals and expectations
Communicate project progress, challenges, and results to management in a clear and timely manner
Identify and assess risks associated with new supplier qualification projects
Implement risk mitigation strategies to ensure the successful qualification of new suppliers
Drive continuous improvement initiatives within the supplier qualification process, incorporating best practices and industry standards
Analyze data and metrics to identify areas for improvement and implement corrective actions
Generate reports summarizing project outcomes, supplier performance, and areas for improvement

Education

Bachelor's or equivalent degree in Engineering or a related field is required. A Master's degree in Engineering is preferred.

Job Qualifications:

Required:

2 years of experience in Manufacturing, Design or Quality function within in the medical device field
Strong analytical skills, including the ability to assess and mitigate risks
Experience with formal problem-solving methodologies and deductive skills
Good understanding of FDA QSRs, ISO13485, Ordinance 169, ISO14971

Preferred:

Experience with handling non-conforming material and assemblies; including root cause investigations pertaining to such non-conformities
Ability to adapt to changing priorities and thrive in a dynamic environment
Proactive and able to work independently as well as collaboratively within a team
Experience with SAP or other ERP system

Other:

Willingness to travel, particularly to visit suppliers (up to 20% required)

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law.

We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :
$69,500-$102,350

Additional Description for Pay Transparency:
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 Additional information can be found through the link below. For additional general information on Company benefits, please go to: • https://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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