Quality Assurance Manager

Molecular Products Quality Assurance ManagerMolecular Products makes specialized air-treatment and gas-processing products—basically technology that helps people breathe safely in environments where air is limited or contaminated. Provides technologies such as CO? absorbers, oxygen generators, and activated carbon filters for healthcare, defense, and industrial use. We are a global leader focused on maintaining safe, breathable air in high-risk and enclosed settings.Purpose of JobTo evaluate QMS processes and ensure they are efficient and scalable with the growth of the business for both MPI and OC Lugo businesses.To lead the maintenance and continual improvement of the QMSTo lead the effectiveness and compliance of MPI with ISO, ITAR and FDA requirementsTo lead in the education of staff and ensure their knowledge of the QMSTo verify the quality of all products and that all required records are being maintainedOrganizationThe QA Manager will be part of Operations, reporting directly to the Business Unit Leader; any conflicts between Operations and Quality will be addressed through the Group Business Unit Leader.All quality assurance and laboratory personnel will report directly to the QA ManagerScopeThe QA Manager will have the authority to stop any production process if he/she feels that there is any issue with the quality of materials being used or produced. The QA Manager will have the authority to stop any shipments he/she feels do not meet quality requirements until the quality of the shipment can be verified.The QA Manager coordinates the operation of the QA laboratory in order to fulfil its' primary function which is to provide accurate, on-time quality control services to the company and our customers, comply with all standards, keep accurate well organized records, stay aligned with corporate goals, and keep the lab operations in a state to deliver on that mission.The QA Manager will, as necessary, schedule meetings and training sessions with all personnel to insure continued compliance with established quality standards.The QA Manager will oversee the following processes: Internal Auditing, Customer Feedback, Change Orders/Document Control, Non-conforming Material, Deviations, Employee Training, Product Acceptance, Corrective Action and Preventive Actions, and calibration.The QA Manager will establish focus groups and ensure effectiveness of said groups to drive the continuous improvement of the QMS.The QA Manager will oversee the collection and reporting of product trending data to monitor for negative trends and/or process improvements.The QA Manager ensures effective root cause analysis in regards to corrective actions or supplier corrective actions and recommends supplementary actions.The QA Manager will schedule and conduct audits of the QMS to the ISO 9001, ISO 13485, MDSAP standards and ITAR requirements as required, including those requested by customers.The QA Manager in coordination with the Logistics Manager will schedule supplier audits as necessary to insure continued supply of high quality raw materials to MPI.The QA Manager has the authority to approve purchases for supporting QA activities including training, documents, and external testing up to $1000. The QA Manager has the authority to approve purchases for laboratory related expenses up to $1200, including laboratory equipment, repairs, supplies, contract laboratory testing, etc.Measurement and ReviewThe success of this role will be measured via the delivery of the following:Maintenance of ISO 9001, ISO 13485 and MDSAP registrationEffectiveness of the QMS (as evidenced by successful audits)Timely completion of corrective actionsCustomer Feedback MetricsAwareness and understanding of the QMS and quality standards by all staffQuality Goals as defined by the Management TeamCompliance to company policies including EH&S, ITAR and QMSQualificationsA minimum 5 years of experience in Quality System managementA minimum of 5 years experience maintaining an ISO 9001, ISO 13485 and MDSAP QMSA minimum of 3 years experience in conducting audits of an ISO 9001, ISO 13485 and MDSAP systemBachelors degree ideally in EngineeringMust demonstrate a working knowledge of ITAR restrictions, Technical Data protection, and restricted visitor protocols.MS Office ¾ Intermediate to Expert knowledgeExcellent written and verbal communication skillsPay: $120,000 - $140,000 USD Annual + 15% annual bonus potentialLocation: This position is fully onsite in Louisville CO. Travel once a quarter to the facility in PA.