Sr Manufacturing Quality Engineer
About The Position
Abiomed is recruiting for a Sr Manufacturing Quality Engineer 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 At Abiomed, part of Johnson & Johnson, we are currently seeking a highly skilled and motivated individual to join our team as a Sr. Manufacturing Quality Engineer to support our facilities expansion. In this role, you will have the unique opportunity to contribute to manufacturing 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 relevant Engineering field is required
- 2-4 years of experience in Quality Assurance/Quality Engineering (QA/QE) in the medical device field
- Experience with formal problem-solving methodologies and deductive skills
- Good understanding of FDA QSRs, ISO13485, ISO14971
- Experience with handling non-conforming material and assemblies, including root cause investigations
- Experienced in qualification of production equipment and validation of production processes
Nice To Haves
- Experience with facility moves and implementation of new equipment in facilities
- Blackbelt or lean certified
Responsibilities
- Provide quality engineering support in the development and manufacturing of new and existing equipment and facilities
- Ensure compliance of manufacturing processes and areas to all applicable quality system regulations
- Lead Quality reporting such as, key performance metrics, goals, and objectives for capital products
- Lead and support activities related to the Material Review Board for facilities
- 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 for any facility and environmental non conformances.
- Monitor and analyze production information to support risk management and provide direction for corrective and preventive actions (CAPA) and/or process improvement activities for facilities
- Validate manufacturing processes, including activities associated with equipment installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), Test method validations (TMV) for facility expansion
- 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 for capital products
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
