Quality Engineer - Pharmaceutical and Medical Device (Grand Rapids, MI)

Quality Engineer - Pharmaceutical and Medical Device

SUMMARY Management Business Solutions (MBS) is seeking a Quality Engineer - Pharmaceutical and Medical Device for our biopharmaceutical client in Marlborough MA. This individual will add value to the company as a quality resource to continuously improve quality methodology within the plant. Can work remotely 2 days a week. RESPONSIBILITIES Plans supports and implements total quality programs. Works closely with Engineering and Manufacturing to design specify and install error-proofing systems and inspection methods. Fulfills the quality-related responsibilities of product process launches. Formulates and assists in the formulation of work instructions and the development of product specifications. Serves as a liaison and coordinates activities of internal and external resources. Assists and or leads internal and external contacts to resolve product and process problems. Investigates and solves manufacturing-related problems in assigned areas using formal problem-solving tools. Analyzes statistical data. Champions continuous improvement efforts. Researches recommends implements and administers new and existing quality assurance processes. QUALIFICATIONS Bachelor s degree in engineering. 5 years previous quality engineer experience. Experience working in a Medical Device industry is required. Lead Quality Auditor certification is required and Quality Engineer (ASQ CQE CRE or equivalent) certification is preferred. Comprehensive knowledge of the rules and specifications regulating quality management systems such as FDA 21 CFR 820 ISO 13485 etc. Good customer relations strong analytical and problem-solving skills. Knowledgeable in Risk Management tools and requirements (i.e. - ISO 14971). Computer skills including Windows Outlook Excel PowerPoint and statistical software programs. MANAGEMENT BUSINESS SOLUTIONS IS AN EQUAL OPPORTUNITY EMPLOYER