- 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.
- A Bachelor's degree in a relevant Engineering field is necessary.
- 6+ years of experience in QA/QE in the medical device field.
- Experience with manufacturing of complex products in environmentally controlled area, catheter-based or cardiac assist devices preferred. Equivalent experience in the manufacturing of similar products will also be considered.
- 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.
-
Sr Design Quality Engineer
3 weeks ago
Johnson & Johnson Digby, NS, CanadaJob Description - Sr Design Quality Engineer W) · Sr Design Quality Engineer W · Description · Abiomed, a part of Johnson & Johnson MedTech, is currently recruiting for a Sr. Design Quality Engineer to be based in Danvers, MA, onsite 3 days a week. · At Johnson & Johnson,we b ...
-
Manufacturing Quality Engineer II
3 weeks ago
Johnson & Johnson Digby, NS, CanadaJob Description - Manufacturing Quality Engineer II - Abiomed W) · Manufacturing Quality Engineer II - Abiomed W · Description · At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are ...
-
Supplier Manufacturing and Quality Engineer
1 week ago
Johnson & Johnson Digby, NS, CanadaJob Description - Manufacturing Quality Engineer II - Abiomed W) · Manufacturing Quality Engineer II - Abiomed W · At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, tre ...
-
Senior Manufacturing and Quality Engineer
5 days ago
Johnson & Johnson Digby, NS, CanadaJob Description - Senior Manufacturing Quality Engineer - Abiomed W) · Senior Manufacturing Quality Engineer - Abiomed W · At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are preven ...
-
Principal Software Design Quality Engineer
1 week ago
Johnson & Johnson Digby, NS, CanadaJob Description - Principal Software Design Quality Engineer W) · Principal Software Design Quality Engineer W · Description · Abiomed, a part of Johnson & Johnson MedTech is recruiting for a Principal Software Design Quality Engineer located in Danvers, MA · At Johnson & Joh ...
-
Principal Software Design Quality Engineer
1 week ago
Johnson & Johnson Digby, NS, CanadaJob Description - Principal Software Design Quality Engineer W) · Principal Software Design Quality Engineer W · Abiomed, a part of Johnson & Johnson MedTech is recruiting for a Principal Software Design Quality Engineer located in Danvers, MA · At Johnson & Johnson,we believe ...
-
Sr Software Design Quality Engineer
3 weeks ago
Johnson & Johnson Digby, NS, CanadaJob Description - Sr Software Design Quality Engineer W) · Sr Software Design Quality Engineer W · Description · Abiomed, part of Johnson & Johnson MedTech, is currently recruiting for a Sr Software Design Quality Engineer to be based in Danvers, MA, onsite 3 days a week · At ...
-
Supplier Engineering Co-op
1 week ago
Johnson & Johnson Digby, NS, CanadaJob Description - Supplier Engineering Co-op W) · Job Number: · Supplier Engineering Co-op ( · Job Number: · W ) Description · ABIOMED is redefining team-driven success while reshaping heart recovery. Here, new ideas are welcomed and encouraged, learning is constant, and ou ...
-
Automation Engineering Consultant
3 weeks ago
Johnson & Johnson Digby, NS, CanadaAbiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to ...
-
Sr Supplier Process Engineer I- Plastics
3 weeks ago
Johnson & Johnson Digby, NS, CanadaAt Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal. Abiomed, part of Johnson & J ...
-
Sr Supplier Process Engineer I- Plastics
3 weeks ago
Johnson & Johnson Digby, NS, CanadaJob Description - Sr Supplier Process Engineer I- Plastics (1 of W) · Sr Supplier Process Engineer I- Plastics (1 of W · Description · Abiomed, part of Johnson & Johnson MedTech is currently recruiting for a Sr Supplier Process Engineer I, Plastics to be based in Danvers, MA ...
-
Data Engineer
1 week ago
Johnson & Johnson Digby, NS, CanadaJob Description - Data Engineering Co-op W) · Data Engineering Co-op ( Job Number: · Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Our in ...
-
Senior Software Engineer
3 weeks ago
Johnson & Johnson Digby, NS, CanadaSoftware Developer full-stack W) · Software Developer full-stack W · Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Our innovative product ...
-
Sr. Lifecycle Engineer
3 weeks ago
Johnson & Johnson Digby, NS, CanadaJob Description - Sr. Lifecycle Engineer W) · Sr. Lifecycle Engineer W · Description · Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abi ...
-
Principal Controls
3 weeks ago
Johnson & Johnson Digby, NS, CanadaJob Description - Principal Controls & Instrumentation Engineer- Abiomed W) · Principal Controls & Instrumentation Engineer- Abiomed W · Description · At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world wher ...
-
Supplier Process Development Engineer II
3 weeks ago
Johnson & Johnson Digby, NS, CanadaJob Description - Supplier Process Development Engineer II (1 of W) · Supplier Process Development Engineer II (1 of W · Description · Abiomed, a part of Johnson & Johnson MedTech, is currently recruiting for a Supplier Process Engineer to be located in Danvers, MA. · At John ...
-
Sr. Software Developer full-stack
3 weeks ago
Johnson & Johnson Digby, NS, CanadaJob Description - Sr. Software Developer full-stack W) · Sr. Software Developer full-stack W · Description · Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hear ...
-
Manager Stagiaire
1 week ago
Johnson & Johnson Digby, NS, Canada InternshipSHIPAbiomed, a part of Johnson & Johnson Med Tech, is currently recruiting for an Advanced Sourcing Manager to be based in Danvers, MA. · At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases ar ...
-
Operations Executive
1 week ago
Johnson & Johnson Digby, NS, Canada InternshipSHIPAt Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal. Lead global multi-functional ...
-
Engineer in Training
5 days ago
Johnson & Johnson Digby, NS, CanadaJob Description - Senior Continuous Improvement (OpEx) Engineer W) · Senior Continuous Improvement (OpEx) Engineer W · Continuous Improvement (OpEx) Engineer to join our Production and Planning Team located in Danvers, MA. · At Johnson & Johnson,we believe health is everything ...
Senior Manufacturing Quality Engineer - Digby, NS, Canada - Johnson & Johnson
Description
Job Description - Senior Manufacturing Quality Engineer - Abiomed W)
Senior Manufacturing Quality Engineer - Abiomed W
Description
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. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at
Abiomed, part of Johnson & Johnson MedTech, is recruiting for a Senior Manufacturing Quality Engineer located in Danvers, MA. In this role, you will have the unique opportunity to contribute to 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.
Responsibilities and Duties:
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit .
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive considerationfor employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin,or protected veteran status and will not be discriminated against on the basis of disability.andEqual Employment Opportunity Posters GINA Supplement.
If you are an individual with a disability, please check ourpage for information on how to request an accommodation.Disability Assistance
This site is governed solely by applicable U.S. laws and governmental regulations. Please see our. Use of this site constitutes your consent to application of such laws and regulations and to our. Your use of the information on this site is subject to the terms of our. You should view thesection and the most recent SEC Filings in thesection in order to receive the most current information made available by Johnson & Johnson Services, any questions or search this site for more information.Privacy Policy Privacy Policy Legal Notice News Investor Contact Us
#J-18808-Ljbffr