Quality Engineer III

Essential functions include, but are not limited to:Provide Quality Engineering project leadership for transfer to manufacturing, and acquisitions, as required.Provide Quality Engineering technical leadership in resolving quality issues.Coordinate validation activities and scheduling, in support of corporate projects.Design, prepare, execute, and analyze engineering studies and/or validations for equipment, processes, and software used in the testing, processing, storing, and distribution of products.Design, prepare, and validate Test Methods.Collect, statistically analyze, and develop report packages to support validations and engineering studies.Develop Validation Master Plans and Validation Project Plans to ensure that all validation tasks required supporting operational areas and corporate projects are identified and completed within established time terface with manufacturing facilities as required.Create, review, and approve documents required for product Design History Files.Update and maintain product Design History Files.Ensure that all policies and procedures for the Risk Management Program are maintained.Work with project teams and necessary departments to identify appropriate process and product hazards, probabilities, severities, and mitigations for Risk Analyses.Perform periodic reviews and updates of Risk Management Files (PFMEAs, AFMEAs/DFMEAs, Risk Management Plans, Risk Management Reports, etc.) according to schedule.Evaluate/Assess equipment, labeling, process, and/or product changes for validation needs and impact to the current Risk Management Files.Perform Internal or Supplier Quality System Audits, as assigned.Analyze process/product non-conformances and implement comprehensive corrective and preventive action plans.Monitor post product data (e.g. Complaints, Corrective and Preventive Actions (CAPA), Non-conformance Reports (NCRs), Customer Feedback information, etc.) for impact to the Risk Management Files.Provide requested investigation reports/evaluations and risk assessments to other departments in a timely manner.Knowledgeable on applicable standards, regulations, and procedures related to tissues and medical devices, both internal and external, as required.Execute high visibility Risk Management projects for the business, as required.Effectively complete "other" functions that may be assigned.QE duties include:Accountability for sampling plans of all types including acceptability of risk given the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls etc. including assessing, applying and interpreting acceptance sampling for manufacturing data. Will take responsibility for ensuring Quality compliance throughout affected areas.Establish and/or maintain Risk Management Files to support product lines and corporate projects.Review and approve design verification / validation protocols and reports generated by external departments that demonstrate the design output fulfills the design input requirements.Conduct investigations, bounding, documentation, review and approval of non-conformances, CAPA''s and customer complaints as necessary.Qualifications: Minimum of a Bachelor''s Degree in an Engineering or science field, or equivalent work experience.Minimum of 5 years hands-on experience in an FDA regulated industry (i.e., pharmaceutical, biomedical, medical device field) with in-depth knowledge of cGMP, ISO 13485, ISO 14971, and relevant international regulations (i.e., EU MDR) and standards.Specific experience designing, preparing, executing, and statistically analyzing validations, as well as developing report packages for equipment, processes, and software used in the receipt, testing, processing, storing, and distribution of raw materials, components, and tissues/products.Specific experience developing and maintaining Risk Management files (PFMEAs, AFMEAs/DFMEAs, Risk Management Plans, Risk Management Reports, etc.).Good knowledge of application of statistical methods and acceptance sampling within a regulated industry such as medical device manufacturing or pharmaceutical.Personal computer skills, i.e., word processing, spreadsheets, data analysis.Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

Created: 2021-11-29