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QUALITY ASSURANCE ENGINEER

AUSTIN, TX 73301

Employment Type: Direct-Hire Industry: SKILLED POSITIONS Job Number: 1917
Summary:
Austin Staffing, Inc. Wants to introduce a mid-level Quality Assurance (QA) Engineer with at least 5 years of experience to our global client. Each day you will be involved with design control, quality support for on-market products, and design transfer support for products under development. The QA Engineer will include developing and leading the Quality System process. You will be instrumental in making improvements and streamlining all process that the Quality Assurance (QA) Engineer is involved with. The Quality Assurance (QA) Engineer is a direct hire position.

Responsibilities:
-Evaluates manufacturing related deviations, non-conformances, customer complaints and process/product change control for completeness and impact on quality for on-market products
-Review consults and approves Risk Analysis
-Serves as Quality representative on product development teams responsible for Design Control requirements for on-market changes
-Provides leadership and guidance for developing equipment/product/process Verification & Validation Protocols, such as IQ, OQ, PQ
-Review records for product release and documents for completeness & accuracy under a production schedule
-Develops and implements quality system documentation
-Identifies key performance metrics and develops a reporting mechanism
-Prepares and presents material at meetings
-Identifies, investigates and leads other departments to resolve quality issues
-Leads audits to established Quality System Manual and applicable regulations and standards
-Supports supplier quality activities
-Leads continuous improvement opportunities and works cross-functionally to implement corrective/preventive actions
-Supports Quality system training and participates in the development of training programs regarding all aspects of producing quality products
-Acts as a resource within and cross-departmental for quality related questions & challenges
-Acts as Escort during external audits/inspections
-Other duties as assigned

Qualifications:
-Bachelor's degree required, in a life science/engineering discipline required
-Experience in a Good Manufacturing Practices (GMP) environment required, preferably in the medical device industry
-Working knowledge of current industry quality practices under QSRs & ISO-13485
-Experience with conducting & supporting audits preferred
-Minimum 5 years' experience in a regulated environment with previous quality experience required
-Experience with change control is preferred
-Certification in a quality discipline preferred, such as CQM, CQA, CQE, etc.
-Strong computer skills (Microsoft Windows and Office programs), familiarity with Oracle preferred
-High degree of problem-solving and analytical skills
-Strong organizational and time-management skills


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