Manufacturing Quality Engineer I

Johnson & Johnson Innovative Medicine•Danvers, MA

1d•$65,000 - $104,650•Onsite

About The Position

At Abiomed, part of Johnson & Johnson, we are currently seeking a highly skilled and motivated individual to join our team as a Manufacturing Quality Engineer I. In this role, you will have the unique opportunity to contribute to the manufacturing of life-saving medical devices. As part of our "Patients First!" culture, you will play a crucial role in ensuring the highest quality standards are met to save lives and recover hearts.

Requirements

A Bachelor's degree in a related Engineering field is preferred.
Experience with formal problem-solving methodologies and deductive skills.
Good understanding of FDA QSRs, ISO13485, ISO14971.
Experience with root cause investigations.

Nice To Haves

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 Savvy

Responsibilities

Providing quality engineering support in the development and manufacturing of new and existing medical devices.
Ensuring compliance of manufacturing processes and areas to all applicable quality system regulations.
Supporting non-conformance investigations, including cause analysis, documenting findings, and approving material dispositions.
Promptly addressing any quality concerns through corrections, corrective/preventative actions, and Escalations.
Validating manufacturing processes, including activities associated with equipment installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), test method validations (TMV).
Collaborating with manufacturing engineering to ensure the implementation of necessary process controls and validations in alignment with industry standards (GMP).
Supporting Quality Management System (process development, creating and editing new and existing SOPs).

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
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
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits