Manufacturing Quality Engineer I
About The Position
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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. We are searching for the best talent for a Manufacturing Quality Engineer I to be based in Danvers, MA. Purpose: 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.
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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
