Manage day to day quality control, quality engineering and document control activities for in-house production and contract manufacturing of all products. Responsible for planning activities concerned with application and maintenance of quality standards and development of procedures for qualification of manufacturing processes, materials and products. Resolve quality problems and improve areas of high-quality costs. Monitor and report on facility quality systems and programs. Represent quality interests and concerns on project teams.
Assure that the Quality System is in compliance with applicable standards and regulations, including cGMP, ISO 9001.
Perform facility internal and external audits and oversee Corrective Action program. Responsible to recommend corrective action to the Quality System based upon internal or external quality reports.
Responsible for the document change control process.
Interface with R&D to ensure that products are designed for patient safety in terms of FMEA, hazard analysis, Quality System compliance and manufacturability.
Develop, refine and document quality control test and inspection procedures.
Support activities related to product verification and validation processes.
Support implementation of sterility and biological test/validation requirements.
Coordinate and assist in the qualification of internal and external manufacturing operations.
Responsible for investigation of product complaints.
Perform other quality engineering duties when requested.
Technical background, scientific judgment, exhibit initiative.
Knowledgeable in application of quality principles and industry guidelines for quality systems.
Strong communication skills.
Ability to conduct an audit and to undergo audit.
Excellent interpersonal skills and ability to motivate others who are not in the department.
Computer literacy, proficiency in MS Office, Excel, PowerPoint, etc.
Excellent organizational skills and attention to detail.
ASQ certification (i.e., CQA, CQE) a plus.