New job Quality Manager, Medical Device (Location - RI)

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Group: JOBS 2.0: Job Search Career Networking Staffing. Post Resume -Get Paid by Employers at Resumark .com Subject: Quality Manager, Medical Device (Location - RI) Arianna Guzman posted a job: Quality Manager, Medical Device (Location - RI) "The Quality Manager for this growing medical device company will be responsible for managing and directing the quality system at the plant level to comply with all standards and customer requirements. Position requirements • Provide Quality support to members of leadership team • Serve as Lead Auditor; manage all internal audits; prepare for registrar audits; address non-compliance issues from both internal and external audits • Develop Quality metrics and goals; lead efforts related to the company’s quality vision • Ensure compliance with FDA and other regulatory affairs • Maintain high standard of customer service to include investigation and resolution of quality complaints • Utilize statistical data to support the development of new products • Review and approve inspection criteria, control plans, PFMEA, and work instructions • Utilize Lean/Six Sigma/TQM principles • Oversee calibration and testing program • Develop quality-related training programs Qualifications • Minimum 5 years experience in Quality Assurance role, medical device manufacturing preferred • Proficiency in Microsoft Office (Word, Excel, PowerPoint) required • Experience with ISO 9001 required; prefer experience with ISO 13485 • Lean/Six Sigma certification preferred • CQE, CQM, CQQ preferred • GD&T and metrology techniques preferred Education Requirements • Bachelor’s Degree or higher in Business, Engineering, or Manufacturing related field Keywords for this position include: Quality, QE, "Quality Engineer" "Quality Assurance" Validation, FDA GR&R, QSR, CQE, IQ OQ PQ, DFMEA, CAPA, ISO, "Quality Systems" 13485, ASQ, CAD, Mimitab, ANOVA, BSME, BSEE, BSBME, "Certified Quality Engineer" "Certified Quality Auditor" "distribution analysis", DOE, "significance test", "process capability", "sampling plans" regression, lean,"

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