Sr Manufacturing Quality Engineer

About the role

Abiomed is recruiting for a Senior Manufacturing Quality Engineer located in Danvers, MA. This role is part of Johnson & Johnson, a company dedicated to healthcare innovation.

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

Qualifications

• Education: A Bachelor's or equivalent degree in a relevant Engineering field is required
• Required Experience and Skills: 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
• Preferred Experience: Facility moves and implementation of new equipment in facilities, Blackbelt or lean certified

Benefits

• 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)).
• Benefits: Employees are eligible for vacation, sick time, holiday pay, personal and family time, parental leave, caregiver leave, volunteer leave, military spouse time-off, and other time off benefits.