Bay Materials LLC
Sr. Quality and Regulatory Affairs Manager
Bay Materials LLC, Fremont, California, us, 94537
Summary of Position:Bay Materials strives to be the best provider of materials used for fabricating devices and treatments in the dental and orthodontic industry. This position is responsible for overseeing the company Quality Management and Regulatory Affairs activities and processes for products marketed in current and future markets, and for ensuring compliance to all applicable Quality System Regulations, including ISO 13485 and any other applicable quality and regulatory requirements for design and manufacturing. 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.
Essential Functions and Duties:Quality ManagementMaintains the company Quality Management System to meet all applicable requirements for design & development, manufacturing and distribution for all Bay Materials productsDrives continuous improvement projects including the development of improved Quality Systems processesManages Quality personnel(s) which may include individuals whose functions include Quality Engineering, Document Control, Incoming Inspection, Quality Assurance Testing, Calibration, Validation, and other related responsibilitiesMaintains a thorough understanding of medical device quality system requirements such as ISO 13485Ensures 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 departmentsEnsures the company internal audit schedule is managed in accordance with existing procedures.Coordinates and prepares site audit from health authority, notified bodies, and key customers.Ensure quality compliance is well established at supplier especially for critical suppliersDevelops and conducts training on key quality topics and best practices including Root Cause Investigations, CAPA investigations, Management Responsibility, GMP/GDP, Audit Readiness, and Validationmanages internal processes and metrics are aligned to create highest product quality to achieve business objectives.Collaborates with Research & Development and Manufacturing organizations to ensure compliance is met and maintained.Follows safety rules and maintains personal safety and the safety of others, including maintaining a clean and safe work areaAccurately records and reports information as requiredEnsure product release according to defined specificationsBe site management representativeRegulatory AffairsAssess regulatory requirements and guidelines for countries in which Bay Materials markets and sells its products.Ensure that all applicable regulatory documentation requirements are met for each country.Coordinate and organize test data and clinical or scientific reviews in support of regulatory submissionsCommunicate with regulatory agencies and reviewers to ask or answer questionsEnsure compliance with product labeling and packaging requirementsCoordinate work or projects with 3rd party testing or consulting servicesPrepare for and lead ISO audits and certifications, or other accreditation effortsPrepare for and support internal and external auditsReview and revise regulatory documents related to company productsReview and approve all sales and marketing materials to ensure compliance with applicable regulatory requirementsNon-essential Functions and Duties:Perform other related duties and responsibilities as assignedManagement Responsibilities:This position manages the following positions: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 responsibilitiesManage and lead diverse teams from different cultural backgroundsFoster an inclusive work environment that respects and leverages cultural differencesProvide training and development programs to enhance cross-cultural competencies within the organizationMinimum Qualifications:Bachelor’s degree in chemistry, biology, engineering, technology, or related science8+ years relevant experience in quality control, quality assurance, and regulatory affairs at a Class I or Class II medical device manufacturer8+ years experience formal ISO 13485 Lead Auditor training or agree to successfully complete such training within the first 6 months of employment8+ years of experience utilizing the basic quality tools including RCA, Fishbone analysis, SPCs, checklists, histograms, Pareto, scatter diagrams, process mapping and flow charts8+ 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
Preferred Qualifications:Masters degree in chemistry, biology, engineering, technology, or related science preferredFamiliarity with GDP (Good Documentation Practices)Familiarity with and competency in Document and Record Control including 21 CFR Part 11 ComplianceFamiliarity with U.S. and International medical device regulationsExcellent interpersonal, verbal, and written communication skillsBasic computer skills, including Microsoft Office Suite
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Essential Functions and Duties:Quality ManagementMaintains the company Quality Management System to meet all applicable requirements for design & development, manufacturing and distribution for all Bay Materials productsDrives continuous improvement projects including the development of improved Quality Systems processesManages Quality personnel(s) which may include individuals whose functions include Quality Engineering, Document Control, Incoming Inspection, Quality Assurance Testing, Calibration, Validation, and other related responsibilitiesMaintains a thorough understanding of medical device quality system requirements such as ISO 13485Ensures 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 departmentsEnsures the company internal audit schedule is managed in accordance with existing procedures.Coordinates and prepares site audit from health authority, notified bodies, and key customers.Ensure quality compliance is well established at supplier especially for critical suppliersDevelops and conducts training on key quality topics and best practices including Root Cause Investigations, CAPA investigations, Management Responsibility, GMP/GDP, Audit Readiness, and Validationmanages internal processes and metrics are aligned to create highest product quality to achieve business objectives.Collaborates with Research & Development and Manufacturing organizations to ensure compliance is met and maintained.Follows safety rules and maintains personal safety and the safety of others, including maintaining a clean and safe work areaAccurately records and reports information as requiredEnsure product release according to defined specificationsBe site management representativeRegulatory AffairsAssess regulatory requirements and guidelines for countries in which Bay Materials markets and sells its products.Ensure that all applicable regulatory documentation requirements are met for each country.Coordinate and organize test data and clinical or scientific reviews in support of regulatory submissionsCommunicate with regulatory agencies and reviewers to ask or answer questionsEnsure compliance with product labeling and packaging requirementsCoordinate work or projects with 3rd party testing or consulting servicesPrepare for and lead ISO audits and certifications, or other accreditation effortsPrepare for and support internal and external auditsReview and revise regulatory documents related to company productsReview and approve all sales and marketing materials to ensure compliance with applicable regulatory requirementsNon-essential Functions and Duties:Perform other related duties and responsibilities as assignedManagement Responsibilities:This position manages the following positions: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 responsibilitiesManage and lead diverse teams from different cultural backgroundsFoster an inclusive work environment that respects and leverages cultural differencesProvide training and development programs to enhance cross-cultural competencies within the organizationMinimum Qualifications:Bachelor’s degree in chemistry, biology, engineering, technology, or related science8+ years relevant experience in quality control, quality assurance, and regulatory affairs at a Class I or Class II medical device manufacturer8+ years experience formal ISO 13485 Lead Auditor training or agree to successfully complete such training within the first 6 months of employment8+ years of experience utilizing the basic quality tools including RCA, Fishbone analysis, SPCs, checklists, histograms, Pareto, scatter diagrams, process mapping and flow charts8+ 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
Preferred Qualifications:Masters degree in chemistry, biology, engineering, technology, or related science preferredFamiliarity with GDP (Good Documentation Practices)Familiarity with and competency in Document and Record Control including 21 CFR Part 11 ComplianceFamiliarity with U.S. and International medical device regulationsExcellent interpersonal, verbal, and written communication skillsBasic computer skills, including Microsoft Office Suite
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