Senior Manufacturing Quality Engineer

Johnson & Johnson Innovative Medicine•Danvers, MA

1d•$79,000 - $127,650•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 Sr. Manufacturing Quality Engineer to support our capital products line (Automated Impella Controller). 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. This position will be located in Danvers, MA.

Requirements

A minimum of Bachelor's or equivalent University degree is required with a focus in engineering or a related field preferred.
Experience in medical device industry working under FDA regulations (21 CFR part 820), ISO 13485 and EU MDR.
Experience with formal problem-solving methodologies and deductive skills.
Good understanding of FDA QSRs, ISO13485, ISO14971.
6+ years of experience in QA/QE in the medical device field.
Experienced in qualification of production equipment and validation of production processes.
Experience with handling non-conforming material and assemblies, including root cause investigations

Nice To Haves

Experience with manufacturing capital equipment that is software enabled. Equivalent experience in the manufacturing of similar products will also be considered.
ASQ CQE certification is a plus
Degree in Software or Electrical engineering is a plus
ISO 13485 Internal audit (or lead Auditor) certificate is a plus.
Experience working with electrical medical devices
Understanding and experience with IEC 62304 software life cycle

Responsibilities

Provide quality engineering support in the development and manufacturing of new and existing capital products
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 capital products
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 capital products
Update and maintain risks management files including PFMEA
Monitor and analyze production information to support risk management and provide direction for corrective and preventive actions (CAPA) and/or process improvement activities for capital products
Validate manufacturing processes, including activities associated with equipment installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), Test method validations (TMV) for capital products
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

employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year