Sr Manufacturing Quality Engineer

6942-ABIOMED Legal Entity • Cherry Hill, NJ

9h • Onsite

About The Position

Abiomed is recruiting for a Sr. Manufacturing Quality Engineer located in Danvers, MA. 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 or equivalent 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

• 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
• 10 days Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior