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Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Danvers, Massachusetts, United States of America, Woburn, Massachusetts, United States of America

Job Description:

Abiomed a member of the Johnson & Johnson Family of Companies, is currently seeking a highly skilled and motivated individual to join our team as a Manufacturing Quality Engineer! This position will be located in Danvers & Woburn, Massachusetts.

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.

Danver Abiomed manufacture Impella heart Pump. Woburn Abiomed produce Sensors and Optical bench which are used for Impella heart.

This individual will be a team member of quality department which will support Woburn site and Danver AIC department.

Position Summary:

Responsible for developing, modifying, applying and maintaining quality evaluation and control systems/protocols. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs and analyzes inspection and testing processes, mechanisms and equipment. Conducts quality assurance tests and performing statistical analysis to assess the level of control and manage product quality risks. Undertakes root cause analysis of incidents requiring corrective action.

This individual will need to be able to support both Danver and Woburn site.

Duties and responsibilities:

• Document production non conformity, conduct investigation, assess product risk, recommend disposition in collaboration with other members of MRB.
• Define and implement action plans and effectiveness monitoring for CAPA originated from Internal/external audits .
• Coaches team members regarding any Quality Engineering non-conformance, subsequent corrective, and preventive actions, by documenting, investigating, and conducting root cause analysis, and successfully implementing corrective actions.
• Confers with team members on process validations for current and new Quality Engineering processes for subsequent operational integration and supply chain implementation.
• Ensures timely escalation of any Quality Engineering issues or concerns to the next management level.
• Identifies, under limited supervision, any Quality Engineering non-conformance, subsequent corrective, and preventive actions, by documenting, investigating, and conducting root cause analysis, and successfully implementing corrective actions.
• Support process validations/revalidation on current and new processes. (IQ, OQ, PQ)
• Implement incoming inspection activities in Woburn facility.
• Collaborate with equipment department for PM and calibration procedural updates. Support for non-conformities from failed calibration, etc.

Qualifications:

Education:

Bachelor's degree in engineering or a related field. The typical engineering degree requirement is waived for candidates with +6 years of experience in quality role.

Required/ Preferred Skillset:

• Minimum of 4 years of experience in quality, preferably in the medical device manufacturing industry.
• Bachelor's degree in engineering or a related field. The typical engineering degree requirement is waived for candidates with +6 years of experience in quality role.
• Experience in medical device industry working under FDA regulations (21 CFR part 820), ISO 13485 and EU MDR. ISO 13485 Internal audit certificate is a plus.
• Solid understanding of IQ, OQ, PQ validation processes and GMP compliance.
• Working knowledge of SAP preferred.
• Proven track record to work independently and manage multiple tasks effectively.
• Excellent problem-solving skills and a proactive approach to challenges.
• Strong communication skills, with the ability to mentor and lead teams effectively.
• Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.
• Preferred certifications: ASQ Certified Quality Engineer (CQE)
• Knowledge of electrical systems, Schematic drawing and IPC 610 is a plus

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 https: //www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is:

• The anticipated salary for this position is expected to be between $77, 000- $124, 200 USD$

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. 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)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 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 Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https: //www.careers.jnj.com/employee-benefits