Johnson & Johnson MedTech
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Manufacturing Quality Engineer
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Johnson & Johnson MedTech At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. 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. Danvers Abiomed manufactures Impella heart Pump. Woburn Abiomed produces Sensors and Optical bench which are used for Impella heart. 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. 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.
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Manufacturing Quality Engineer
role at
Johnson & Johnson MedTech At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. 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. Danvers Abiomed manufactures Impella heart Pump. Woburn Abiomed produces Sensors and Optical bench which are used for Impella heart. 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. 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.
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