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Senior Quality Engineer - Wilmington, United States - Katalyst Healthcares and Life Sciences
Description
Responsibilities:
Support validations for new and existing products, processes and equipment.
Manage NC/CAPA teams through identification and development of corrective action plans, verification and closure.
Coordinate and support supplier quality management activities, including qualification and evaluation, supplier investigations, etc...
Manage and support batch record review and disposition of product.
Support and prepare for site-level internal, external, supplier and customer audits.
Apply systematic problem-solving methodologies and provide quality support to identify and resolve quality issues to ensure production of safe and effective medical devices.
Identify and implement opportunities for continuous improvement.Interact and coordinate activities with other departments, external vendors and customers.
Perform other Quality System related duties as required.
Non conformance, Capa, ISO 13485, FDA, validation, audit, risk management, pFMEAS, batch record review, continuous improvement, bachelors degree, quality engineering, GMP, medical device, process engineering, IQ, OQ, PQ, external audit, internal audit, customer identity, QMS
Nonconformance, Capa, ISO 13485,FDA,validation,audit,risk management, pFMEAS, batch record review, continuous improvement, bachelor's degree, quality engineering, GMP, medical device
Requirements:
Bachelors degree required, preferably in Engineering, Science (Chemistry, Biology, Physics, etc) or Math (Statistics).
5+ years of experience in roles with increasing levels of complexity and scope.
Experience in an FDA regulated manufacturing or industrial environment.
Strong working knowledge of FDA / ISO 13485 Quality System. requirements, GxP, and other relevant standards and regulations.
Technical skills and experience related to process validation, statistical methods, and risk management.
Experience performing quality audits. Certified Quality Auditor (ASQ CQA) or Certified Quality Engineer (ASQ CQE) preferred.
Lean manufacturing / Six Sigma helpul
Strong cross-collaborator, effective coaching and mentoring skills
Ability to work independently, well organized and self-driven.
Excellent written and verbal communication skills.
Experience Level:
* looking for 3-5 years of experience
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