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Senior Quality Engineer

  • Anywhere

Company :
Michael Page

Location :
Manhattan, New York

Expiry Date :
Tue, 15 Jun 2021 23:59:59 GMT

Apply Job :
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Description :
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual’s status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants. *Description* * Participate in maintaining and monitoring FDA QSR 21 CFR 820 and ISO 13485 systems or other recognized regulatory standards for all markets in which our products are sold. * Establish processes and procedures to ensure compliance and improve the Quality Management System (QMS). * Investigate and diagnose customer complaints, quality issues, and non-conformances. * Develop, recommend and monitor corrective and preventive actions (CAPAs) and change controls (CRs). Evaluate audit findings and implement appropriate CAPAs/CRs. * Conduct post-market activities including complaints handling, internal investigations, MDR evaluations, and CAPA assessments. * Work with suppliers, laboratories, customers, and other group members to assist with implementation and effectiveness of customer deliverables. * Review documents and records for accuracy and technical application of standards. * Support QA Management with department strategy development, objectives and goal setting, project prioritization activities. * Bachelor’s degree in Science, Quality Assurance, Engineering or related scientific discipline. * Minimum 5 years’ experience working with cGMPs in QA / QC for a medical device and/or pharmaceutical manufacturer. * Direct contact/interaction experience with the FDA, ISO registrars and other regulatory bodies is required. * Experience with pharmaceutical and medical device test standards and assay validations (USP, ISO, AAMI, ASTM, and IEC). * Experience working with investigations, non-conformances, complaints, MDRs, CAPAs and change controls. * Experience with metrology, equipment qualifications and system validations. * Experience reviewing batch records and releasing batches for commercial use. * Auditor Certification such as ASQ CQA preferred. This client is a rapidly growing company that specializes in medical device technology in the animal health, trauma care, and surgical markets. * Competitive base salary * Excellent benefits package * Paid vacation and holidays * Growth opportunity * Reports up to executive leadership of a rapidly growing medical device company * Significant company funding