Quality Assurance Manager

Purpose of job

• To 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 QMS
• To lead the effectiveness and compliance of MPI with ISO, ITAR and FDA requirements
• To lead in the education of staff and ensure their knowledge of the QMS
• To verify the quality of all products and that all required records are being maintained

Organization

• The 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 Manager

Scope

• The 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 review

The success of this role will be measured via the delivery of the following:

• Maintenance of ISO 9001, ISO 13485 and MDSAP registration
• Effectiveness of the QMS (as evidenced by successful audits)
• Timely completion of corrective actions
• Customer Feedback Metrics
• Awareness and understanding of the QMS and quality standards by all staff
• Quality Goals as defined by the Management Team
• Compliance to company policies including EH&S, ITAR and QMS

• A minimum 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
• Bachelors degree ideally in Engineering
• Must demonstrate a working knowledge of ITAR restrictions, Technical Data protection, and restricted visitor protocols.
• MS Office ¾ Intermediate to Expert knowledge
• Excellent written and verbal communication skills

Pay: $120,000 - $140,000 USD Annual + 15% annual bonus potential

Location: This position is fully onsite in Louisville CO. Travel once a quarter to the facility in PA.