Sr Manufacturing Quality Engineer Job Danvers area,Massachusetts USA,Engineering

Sr Manufacturing Quality Engineer

Abiomed is recruiting for a Sr Manufacturing Quality Engineer 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. 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.

Key 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

Experience and Skills:

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, ISO
13485, ISO
14971
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 with facility moves and implementation of new equipment in facilities
Blackbelt or lean certified

Other:

Up to 10% domestic and international travel is required
Role is on site at our Danvers, MA facility

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via Internal employees contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is:…