Senior Quality Assurance Engineer

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 product realization efforts, including Design Verification & Validation. Lead and manage design related CAPAs, NOEs and deviations. Participate in risk analysis activities at different phases of products development, production and commercialization. Monitor risk management activities Participate in risk planning, risk analysis, design controls, verification and validation, and inspection methods and procedures. Evaluate and approve of contract-manufacturers/suppliers for new products. Help establish internal and external inspection requirements for new products. Review, approve, and implement inspection plans. Support product design transfers to contract-manufacturers/suppliers. Participate in the review and approval of Engineering Change Orders and the review and approval of detailed drawings. Analyze customer complaints to determine root cause. Participate in handling MDRs. Review collected data and trends to make them available for the periodic update of product Risk Management. Participate in maintaining and monitoring the following quality systems and supporting documentation: Audit system, CAPA system, FDA QSRs system and ISO 13485 system. Review, update, and implementation of procedures affecting quality assurance. Bachelor's degree in Science, Quality Assurance, Engineering or related scientific discipline. Working knowledge of ISO 13485, FDA 21 CFR 820, and ISO 14971. Complete understanding of GMP and GLP. Expert understanding of Design Controls. Experience working in Design Assurance / Quality Assurance in a medical device manufacturing environment. Experience with drafting and reviewing change control, IQ, OQ, PQ, verification, and validation protocols. Experience with investigations, root cause analysis and CAPAs. Experience with software validation. Ability to draft and review SOPs, which comply with internal and external standards. Six Sigma Black Belt or Green Belt certification. Excellent structured problem solving and analytical skills. 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