Quality Assurance Manager
About The Position
Molecular Products makes specialized air-treatment and gas-processing products, including CO₂ absorbers, oxygen generators, and activated carbon filters for healthcare, defense, and industrial use. They are a global leader focused on maintaining safe, breathable air in high-risk and enclosed settings. The purpose of this job is to evaluate Quality Management System (QMS) processes and ensure they are efficient and scalable with the business growth for both MPI and OC Lugo businesses. The role involves leading the maintenance and continual improvement of the QMS, ensuring the effectiveness and compliance of MPI with ISO, ITAR, and FDA requirements, educating staff on the QMS, and verifying product quality and record maintenance.
Requirements
- A minimum of 5 years of experience in Quality System management.
- A minimum of 5 years of experience maintaining an ISO 9001, ISO 13485, and MDSAP QMS.
- A minimum of 3 years of experience in conducting audits of an ISO 9001, ISO 13485, and MDSAP system.
- Bachelors degree ideally in Engineering.
- 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.
Responsibilities
- Evaluate QMS processes for efficiency and scalability.
- Lead the maintenance and continual improvement of the QMS.
- Ensure the effectiveness and compliance of MPI with ISO, ITAR, and FDA requirements.
- Lead in the education of staff regarding the QMS.
- Verify the quality of all products and ensure required records are maintained.
- Coordinate the operation of the QA laboratory to provide accurate, on-time quality control services.
- Schedule meetings and training sessions to ensure continued compliance with quality standards.
- Oversee 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 to drive continuous improvement of the QMS.
- Oversee the collection and reporting of product trending data.
- Ensure effective root cause analysis for corrective actions and supplier corrective actions.
- Schedule and conduct audits of the QMS to ISO 9001, ISO 13485, MDSAP standards, and ITAR requirements.
- Schedule supplier audits in coordination with the Logistics Manager.
- Approve purchases for supporting QA activities (training, documents, external testing) up to $1000.
- Approve purchases for laboratory-related expenses (equipment, repairs, supplies, contract testing) up to $1200.
- Meet regularly with the Business Unit Leader (monthly minimum).
- Conduct regularly scheduled quality group meetings and facilitate annual review of QMS effectiveness.
- Serve as a liaison with customers and suppliers regarding quality issues.
- Meet regularly with QA department and laboratory employees (informally monthly minimum, formally quarterly minimum).
- Work closely with all departments to lead the maintenance and improvement of MPI’s QMS.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
