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Job Function:
Supply Chain EngineeringJob Sub Function:
Quality EngineeringJob Category:
Scientific/TechnologyAll Job Posting Locations:
Danvers Massachusetts United States of AmericaJob Description:
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. Abiomeds 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.
Abiomed is recruiting for an EntryLevel Supplier Quality Engineer Electronics to be located in Danvers MA.
About MedTech Fueled by innovation at the intersection of biology and technology were 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 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. Abiomeds 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.
Act as the primary technical point of contact with suppliers who provide electronic components and custom assemblies (PCBAs consoles cables batteries housings etc.).
Lead supplier investigations and rootcause analysis (5Why fishbone) and track/implement corrective and preventive actions.
Monitor supplier performance metrics (PPM ontime delivery NCRs) and analyze trends using SPC.
Assess risk through FMEAs and develop process validation plans (MVP IQ/OQ/PQ) to be executed at supplier
Act as a technical partner with internal incoming inspection teams to assess defects and manage non-conformance investigations
Collaborate with engineering procurement and manufacturing to resolve quality issues and improve processes.
Compile analyze and summarize supplier performance data for Supplier Scorecards
Education:
BS degree in electrical engineering or related engineering field and 2 years of related experience
Required:
Effective communication skills across all levels of the organization
Understanding of electrical components and custom assemblies (PCBAs consoles cables batteries housings etc.)
Strong technical writing skills
Ability to travel up to 10% of the time
Must be proactive self-motivated and able to work independently with minimal supervision
Ability to work independently in a fast-paced environment while managing multiple priorities
Experience in the medical device industry is strongly preferred
MS degree in an electrical engineering field
Knowledge of cGMP FDA 820 QSR ISO 13485 or other Quality Systems
Knowledge of statistics (hypothesis testing capability analysis DOE MSA) Six Sigma Lean
Certifications (CQE Lead Auditor Six Sigma Project Management)
Ability to travel up to 10% of the time
Required Skills:
Preferred Skills:
Customer Centricity Data Savvy Document Management Execution Focus Good Automated Manufacturing Practice (GAMP) Issue Escalation Lean Supply Chain Management Process Control Process Improvements Quality Control (QC) Quality Services Quality Standards Quality Systems Documentation Science Technology Engineering and Math (STEM) Application Supervision Supply Planning Technologically SavvyThe anticipated base pay range for this position is :
$65000.00 - $104650.00Additional Description for Pay Transparency:
This position is eligible to participate in the Companys long-term incentive program.IC
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more