Supplier Quality Engineer II
About The Position
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. Abiomed is recruiting for an Entry‑Level Supplier Quality Engineer — Electronics 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. Position Overview: 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.
Requirements
- BS degree in electrical engineering or related engineering field and 2+ years of related experience
- 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
Nice To Haves
- 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)
Responsibilities
- 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 root‑cause analysis (5‑Why, fishbone) and track/implement corrective and preventive actions.
- Monitor supplier performance metrics (PPM, on‑time 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
Benefits
- This position is eligible to participate in the Company’s long-term incentive program.
- Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period10 days
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
