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Manages Quality personnel(s) which may include individuals whose functions include Quality Engineering, Document Control, Incoming Inspection, Quality Assurance Testing, Calibration, Validation, and other related responsibilities.
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8+ years relevant experience in quality control, quality assurance, and regulatory affairs at a Class I or Class II medical device manufacturer. Ensures required quality procedures are established including CAPA, Non-Conforming Product, Risk Management, Post-market-surveillance, Purchasing Controls, Management Review, Traceability, Employee Controls, Post market management, Change Control, Advisory Notifications, Supplier compliance and others as coordinated within the Quality team and with other cross-functional departments.
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Assists the Histology Manager in overseeing the quality assurance programs, the preventive maintenance program and the safety program for the department. Assists the Histology Manager in overseeing the quality assurance programs, the preventive maintenance program and the safety program for the department.
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Develops and conducts training on key quality topics and best practices including Root Cause Investigations, CAPA investigations, Management Responsibility, GMP/GDP, Audit Readiness, and Validation.
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8+ years of experience utilizing the basic quality tools including RCA, Fishbone analysis, SPCs, checklists, histograms, Pareto, scatter diagrams, process mapping and flow charts. Drives continuous improvement projects including the development of improved Quality Systems processes.
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8+ years of experience producing technical documents, such as draft management review, KPIs at defined timeline, risk management for the quality system and formal procedures/ work instructions. Ensure quality compliance is well established at supplier especially for critical suppliers.
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Manages internal processes and metrics are aligned to create highest product quality to achieve business objectives. Maintains the company Quality Management System to meet all applicable requirements for design & development, manufacturing and distribution for all Bay Materials products.
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We develop, manufacture, and supply dental implants, clear aligners, instruments, CADCAM prosthetics and biomaterials for use in esthetic dentistry, tooth replacement and restoration solutions or to prevent tooth loss.
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Masters degree in chemistry, biology, engineering, technology, or related science preferred. This role will evolve along with the company QMS as the company develops and commercializes new products and gains approval to market in various geographic markets.
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Bachelor’s degree in chemistry, biology, engineering, technology, or related science. From the first Dental Implant in 1974 to the latest Digital Solution – we do things differently than others. Bay Materials strives to be the best provider of materials used for fabricating devices and treatments in the dental and orthodontic industry.
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Ensures the company internal audit schedule is managed in accordance with existing procedures. Prepare for and lead ISO audits and certifications, or other accreditation efforts. Coordinate and organize test data and clinical or scientific reviews in support of regulatory submissions.
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Preference will be given to candidates with prior experience in a QA Engineering role, particularly those with a background in machining/welding manufacturing, non-destructive testing, shop surveillance, inspection, data trending, procedure development, supplier quality/oversight, and corrective action.
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Ensure compliance with product labeling and packaging requirements. Provide training and development programs to enhance cross-cultural competencies within the organization. Review and approve all sales and marketing materials to ensure compliance with applicable regulatory requirements.
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Assess regulatory requirements and guidelines for countries in which Bay Materials markets and sells its products. Foster an inclusive work environment that respects and leverages cultural differences.
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Great health, dental and vision insurance packages to fit your needs to ensure you’re happy and healthy. Coordinate work or projects with 3rd party testing or consulting services. We empower our employees to perform and make an impact, to question the status quo, to drive change, to stay ahead of the competition.
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quality assurance qa qc manager jobs Company: Green Thumb
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