Quality Manager

DescriptionThe main responsibilities within the role of the Quality Assurance Manager will be to ensure the highest standards are met in accordance with regulatory requirements and/or stated standards (ISO & FDA); to continuously improve our quality reporting processes; to manage the team to ensure quality assurance results are maintained and produced in a timely manner; to control, review and challenge our quality associates on customer standards to ensure compliance by providing advice and support.The ideal candidate will be required to read and interpret engineering drawings and quality specifications, to prepare quality inspection procedures and investigate and resolve quality problems; manage customer and third party quality audits as required; manage and/or perform direct internal quality audits; act as liaison with customers on quality issues; communicate company Quality Objectives to all employees; and work closely with all departments to build a Quality Team.Key ResponsibilitiesResponsible for site regulatory complianceEnsure maintenance and implementation of Quality Systems and trainingAct in conjunction with Plant Manager as technical contact on quality-related issuesAddress customer concerns, applying root-cause analysis and problem-solving skillsAid in development of suppliers and implementation of Quality Systems Documentation including training documentation and providing appropriate trainingLead audits by Third-Party Registrars/CustomersFully support and work with all departments to ensure quality standards are upheldProvide leadership within the daily QA activities and promote a Quality culture throughout the facility.Support utilization of ISO and QMS systems cost-effectivelyUtilize APQP/PPAP, process flow maps, FMEAs, control plans and measurement system evaluations to support Quality Standard requirementsEnsure Quality documentation is current with Corrective Actions (PFMEA, Control Plans, Flow Charts, etc)Manage and report key Quality Performance MetricsWork with other disciplines to ensure the integrity of an ISO Class 8 cleanroomPromote company Core Values with key focus on SafetyAssist with other various duties as assigned by managementJob QualificationsMust possess degree of Science or Business or similar, with 3-5 years' experience in Quality Assurance in a manufacturing environmentMust have a thorough understanding and working knowledge of ISO 9001:2015 and ISO 13485:2016 standards.Must be a certified Lead Auditor.Must have experience managing third party regulatory and customer audits.Must have thorough understanding of QA/QC theory, procedures and practices, including potential failure modes for company product linesMust have basic understanding of manufacturing processes and operation systemsMust possess strong communication, presentation and analytical skillsMust have ability to negotiate and communicate successfully at all levelsMust possess strategic planning and development skillsMust have extensive knowledge of measuring/test equipment, gauging practices and capability of undertaking full GR&RsMust possess working knowledge of computers, software applications (at least: Word, Excel, Visio, Access and Outlook) and excellent reading/comprehension skillsExperience:ISO Certification: 2 years (Preferred)Quality Assurance: 3 years (Preferred)Manufacturing: 3 years (Preferred)Education:Bachelor's (Preferred)