Experienced Engineer Manufacturing Quality

Johnson & Johnson Innovative Medicine • Danvers, MA

5d • 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 an Experienced Engineer Manufacturing Quality, to be located in Danvers, MA. 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. 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 minimum of a Bachelor's degree, preferably in an Engineering field or related technical field
• 2-4 years of relevant experience
• Experience working in Manufacturing/Operations
• In-depth knowledge of product/process Risk Management (FDA and ISO standards)
• Experience with a proven track record of implementing appropriate risk mitigation
• Good technical understanding of manufacturing equipment and processes

Nice To Haves

• Experience working in both an FDA and European regulatory environment
• The ability to perform "hands on" troubleshooting and problem solving is preferred while quick thinking and sound judgment is highly desired
• A thorough understanding of GMP/ISO regulations and validation regulations
• Demonstrated project management and project leadership abilities

Responsibilities

• Provide quality engineering support in the development and manufacturing of new and existing medical devices.
• Ensure compliance of manufacturing processes and areas to all applicable quality system regulations.
• Lead Quality reporting such as, key performance metrics, goals, and objectives.
• Lead and support activities related to the Material Review Board.
• 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.
• Monitor and analyze production information to support risk management and provide direction for corrective and preventive actions (CAPA) and/or process improvement activities.
• Validate manufacturing processes, including activities associated with equipment installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), Test method validations (TMV).
• 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.

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
• 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: Mid Level