Quality Engineering S

Job-ID31410467Reference25-04318 The Quality Engineer is accountable for supporting new product development and product maintenance through the application of Quality Engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance, and play an active role in the process to ensure products meet quality standards consistent with both Corporate and Unit policies, while meeting all design control and other regulatory requirements.Consistent application of technical principles, theories, concepts, techniques, and quality sciences/tools.

Ensures that all design control and production/process control projects meet applicable regulatory (local and international), Corporate, and Unit requirements.

Acts as a team member representing Quality on new product development and sustaining engineering projects.

Reviews and has Quality Engineering approval authority for new and modified design/process specifications including product performance specification, test methods, etc.

Assists with supplier and internal quality system audits as a means of evaluating the effectiveness of the established Quality System and good manufacturing practices (Auditor-in-training).

Typically requires a minimum of a bachelor's degree in science, engineering, or other relevant discipline and a minimum of 5 years relevant experience or a combination of equivalent education and relevant experience.

• Applied knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g. - Applied knowledge of Corporate and/or Unit requirement.
• Able to contribute to the completion of specific programs and projects.
• Can ensure quality conduct of projects, including design, data summary and interpretation, and report generation for self and lower level project developers.
• Able to revise policies and procedures
• Able to provide guidance and work direction to lower level project developers.
• Experience with Client software systems utilized in the Quality Systems is desirable.

Acceptance sampling theory and applicationStatistical process control methods and applicationMeasurement system/test method knowledge and analysisQuality planningFailure analysis investigationDesign of ExperimentsProcess mapping and value stream analysisHypothesis testingDescriptive statisticsProcess capability analysisBasic quality tools: Risk ManagementSupplier quality managementAuditingDesign/development toolsProcess validationSoftware validation