Quality Assurance Manager

Responsibilities

• Evaluate and ensure efficiency and scalability of QMS processes for both MPI and OC Lugo businesses.
• Lead the maintenance and continual improvement of the QMS.
• Lead the effectiveness and compliance of MPI with ISO, ITAR, and FDA requirements.
• Lead in the education of staff and ensure their knowledge of the QMS.
• Verify the quality of all products and maintain required records.
• Coordinate the operation of the QA laboratory to fulfill its primary function of providing accurate, on-time quality control services.
• Schedule meetings and training sessions with all personnel to ensure continued compliance with established quality standards.
• Oversee various processes including Internal Auditing, Customer Feedback, Change Orders/Document Control, Non-conforming Material, Deviations, Employee Training, Product Acceptance, Corrective Action and Preventive Actions, and calibration.
• Establish focus groups and ensure their effectiveness to drive continuous improvement of the QMS.
• Oversee the collection and reporting of product trending data to monitor for negative trends or process improvements.
• Ensure effective root cause analysis in regards to corrective actions or supplier corrective actions and recommend supplementary actions.
• Schedule and conduct audits of the QMS to ISO 9001, ISO 13485, MDSAP standards and ITAR requirements as required, including those requested by customers.
• Schedule supplier audits as necessary to ensure continued supply of high-quality raw materials to MPI.
• Award purchases for supporting QA activities including training, documents, and external testing up to $1000.
• Award purchases for laboratory related expenses up to $1200, including laboratory equipment, repairs, supplies, contract laboratory testing, etc.

Qualifications

• A minimum of 5 years of experience in Quality System management.
• A minimum of 5 years experience maintaining an ISO 9001, ISO 13485 and MDSAP QMS.
• A minimum of 3 years experience in conducting audits of an ISO 9001, ISO 13485 and MDSAP system.
• Bachelor's degree ideally in Engineering.
• Demonstrate a working knowledge of ITAR restrictions, Technical Data protection, and restricted visitor protocols.
• Intermediate to Expert knowledge of MS Office.