What are the responsibilities and job description for the Sr Quality Engineer position at cGxPServe?
Responsibilities :
Perform New Product Development of Surgical Medical Devices in this division, We are looking for an Engineer to perform & work mainly on Quality Tasks.
Create, test, and / or improve products by developing moderately complex experiments and tests (including writing and executing protocols), analyze results, make recommendations, and develop reports, based on engineering principles.
Driving process and equipment validations (ex. TFIQ, IQ, OQ, PQ).
Drafting, approving, executing, and maintaining all relevant documentation (ex. SOPs, operator training, specifications, drawings, process sheets, FMEAs, and validation plans).
Create / update portions of design control documents including requirement specs and risk documents.
Assign R&D support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work.
Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers.
Other duties assigned by Leadership.
Requirements :
Bachelor's degree in engineering or Scientific field & 4 years' experience -OR- Master's Degree or equivalent in Engineering or Scientific field & 3 years' experience.
CAD experience (Solidworks -or- Creo).
Statistical based software (Minitab, JMP).
Keyence, and Other Inspection Methods.
Data Analysis (Stat), 3D modeling.
Drawing Review and Inspection.
Preferred Skills :
Medical Device experience is strongly preferred.
Experience in test method development including Fixture development and Validation.
Basic understanding of statistical techniques.
Develop, update, and maintain technical content of risk management files.
Understanding and knowledge of principles, theories, and concepts relevant to Engineering.
Solid problem-solving, organizational, analytical, and critical thinking skills.
Good documentation, communication (e.g., written and verbal), and interpersonal relationship skills including consultative and relationship management skills.
Ability to interact professionally with all organizational levels & time management.
Ability to manage competing priorities in a fast-paced environment.
Ability to build productive internal / external working relationships.
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