Job Function:
Supply Chain Engineering
Job Sub Function:
Quality Engineering
Job Category:
Scientific/Technology
All Job Posting Locations:
Danvers, Massachusetts, United States of America
Job Description:
At Abiomed, part of Johnson & Johnson, we are currently seeking a highly skilled and motivated individual to join our team as an Manufacturing Quality Engineer I, to be located in Danvers, MA.
An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.
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.
Responsibilities and Duties:Provide quality engineering support in the development and manufacturing of new and existing medical devices.
Ensure compliance of manufacturing processes and areas to all applicable quality system regulations.
Lead Quality reporting such as, key performance metrics, goals, and objectives.
Lead and support activities related to the Material Review Board.
Lead non-conformance investigations, including cause analysis, documenting findings, and approving material dispositions. Promptly address any quality concerns through corrections, corrective/preventative actions, and Escalations.
Monitor and analyze production information to support risk management and provide direction for corrective and preventive actions (CAPA) and/or process improvement activities.
Validate manufacturing processes, including activities associated with equipment installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), Test method validations (TMV).
Collaborate with manufacturing engineering to ensure the implementation of necessary process controls and validations, while adhering to established guidelines (GMP).
Support process optimization using design of experiments (DOE) and retrospective data analysis to understand and minimize sources of process variation affecting products. 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 and external auditing requirements in manufacturing.
Qualifications:Education:
Experience and Skills:Required:
This position will require 0-2 years of relevant experience
Experience working in Manufacturing/Operations
In-depth knowledge of product/process Risk Management (FDA and ISO standards)
Experience with a proven track record of implementing appropriate risk mitigation
Good technical understanding of manufacturing equipment and processes
Preferred:
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 Testing, Quality Services, Quality Standards, Quality Systems Documentation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically Savvy
The anticipated base pay range for this position is :
$65,000.00 - $104,650.00
Additional Description for Pay Transparency:
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
