Quality Assurance Manager Sensors for Medicine and Science

Sensors for Medicine and Science, a clinical stage medical device company; seeks an experienced Quality Assurance Manager with a take charge attitude and initiative necessary to drive the Companys quality efforts.

Job Functions:

Implement and/or monitor programs to promote quality consciousness among employees and outside contractors, e.g. QSR training, quality teams, design controls, production/process controls, quality audits and "Good Manufacturing Practices" (GMP) inspections.
Monitor and supervise compliance of outside contractors to established manufacturing methods and procedures.
Establish and/or implement parent company product quality standards, specifications, parameters, testing methods, design controls and manufacturing methods.
Render product clearance decisions at different stages of the production process in order to authorize continuation of production until eventual release for sale or clinical trial.
Assume full responsibility for batch releases, approval of master documents, documentation of quality investigations etc.
Responsible for "QA-Validation" activities, quality audits, and quality training to ensure:
Compliance with quality standards by suppliers of materials and services
Efficacy of testing methods
Soundness of manufacturing practices
Effectiveness of support systems (water purification and climate controls)
Efficient application of machinery, plant and procedures in order to avoid mix-ups with materials, packaging components and batch identifications
Quality consciousness of all employees at the site
Analyze quality deviations and initiate appropriate remedial actions, such as reworks, retests and procedural improvements; or initiate product recalls when products with critical quality defects are already for sale on the market
Communicate, through management reviews, significant quality issues and corrective actions to upper management.

Qualifications:

B.S. in Engineering or related technical field of study.
Quality Engineering Certification (ASQ), preferred.
5 - 10 Years experience in manufacturing of Medical Devices
Working knowledge of ISO 13485, Medical Device Directive and FDA QSR/ GMP/GLP and CE mark
Excellent documentation and computer skills.
Leadership and managerial qualities, excellent communication and interpersonal skills
Comfortable working under limited supervision and direction.
Able to prioritize work, multi-task and work under deadline pressures.

Location:	12321 Middlebrook Road Suite 210 Germantown, MD 20874 United States