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Senior Design Quality Engineer

Company: Exactech
Location: Gainesville
Posted on: March 21, 2020

Job Description:

The Sr Quality Engineer shall develop inspection methods for raw materials, finished products, and products provided by suppliers. Assistance, as it relates to Quality, will be given in areas such as process verifications, validations, design control review, non-conforming material disposition, change control review, CAPA, and auditing. Duties and Responsibilities (Key Deliverables): 1. Participates in E&D design control processes related to design inputs and defines product/process inspection requirements for all current and new products. Develops Quality plans to include inspection drawings and specifications. Designs and/or purchases inspection equipment and fixtures as required. 2. Provides verification and validation expertise through IQ, OQ, and PQ protocol development and execution utilizing approved product and process validation SOP. 3. Develops and validates statistical methodologies and quality inspection sampling plans for internally manufactured and vendor supplied products, processes and components. 4. Develops internal reports to provide key quality operating measurement trending for all Operations functions. 5. Leads and/or participates in vendor quality audits and in the development of a Supplier Management Program. 6. Leads and/or participates in company-wide Corrective and Preventive Actions projects. 7. Analyzes, justifies and recommends purchase of in house or vendor supplied inspection equipment. 8. Participates as team member on MRB related actions. 9. Responsible for inspection, investigation and documentation of product customer complaints. 10. Responsible for calibration systems management. 11. May supervise the activities of QE technicians 12. Responsible for QE related DCN product and process change review and approval. 13. Provides inputs for software validation processes. 14. Direct or assist inspection training for QC inspectors and QE technicians. 15. Develop, monitor and provide timely feedback for quarterly goals and objectives. 16. Participates and may lead discussions on highly technical issues related to FDA and ISO compliance inspections. 17. Know and apply the Quality System and any appropriate Federal and International standards. 18. Assist and support other team members as necessary. Job Requirements: Education: Bachelor---s Degree from an accredited institution required; Master---s Degree preferred Experience: -- Minimum 7 years experience in the medical device industry -- Experience in GD&T and use of advanced inspection equipment -- Advanced level of technical software proficiency -- Advanced Quality Systems knowledge required Functional/Technical Knowledge, Skills and Abilities Required: -- Certified Quality Engineer -- Thorough understanding and application of statistical analysis and sampling plans -- Ability to work effectively in a team environment

Keywords: Exactech, Gainesville , Senior Design Quality Engineer, Engineering , Gainesville, Florida

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