Quality Assurance Manager IMMCO Diagnostics, Inc.
Reports to: Chief Regulatory Officer
Summary: Individuals serving in this position will be responsible for managing both departmental objectives in maintaining compliance with the quality management system (cGMP/ ISO13485) and direct report performance objectives.
Maintain Immco Quality Management System (QMS) in compliance with relevant external standards, including:
FDA Quality System Regulation (QSR)
Clinical Laboratory Evaluation Program (CLEP)
Canadian Medical Device Regulation (CMDR)
EU Medical Device IVD standards
Management Representative Designee with responsibility and authority to manage, monitor, evaluate and coordinate the organization's quality management system as necessary to meet customer and other requirements and achieve specified quality objectives.
Responsible for communicating regarding QMS compliance to Top Management, as well as the customer and other interested parties on matters pertaining to the organization's quality management system.
Ensure that the processes needed for the organization's QMS are established, implemented, and maintained
Ensure the promotion of awareness of customer requirements throughout the organization
Oversee internal and external (regulatory, customer and vendor) audits
Conduct/review quality system and job specific training program company wide
Review compliance with procedures for the manufacture of products and reference laboratory testing in accordance with quality requirements
Execute quality system planning
Manage complaint handling and corrective and preventative action systems
Validates quality processes by establishing product specifications and quality attributes;
Measuring production and determining operational and performance qualification
Writing and updating quality assurance procedures.
Collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations
Manage medical device licensure and annual establishment licensure for US and Canada
Maintain and update all regulatory documents
Oversee inspections on finished product, labels and associated documents
Mentor, train and manage the day-to-day activities of direct report personnel
Ensure staff growth and development through performance reviews, cross training, goal setting and new hire training.
Provide recommendations for and facilitate the improvement of existing processes in order to reduce departmental expenditures and expenses.
This position requires, at a minimum, a 2 year college degree along with specific experience to assess effectiveness of quality management system implementation and/or certification and 4 years experience in related field with cGMP and ISO9001/13485 IVD compliance requirements
In-depth knowledge of cGMP and ISO 9001 / 13485 systems
2-3 years supervisory experience.
General MS Office computer skills including experience with inventory management systems
Accuracy in recordkeeping and in sorting, checking, counting and verifying items
Problem solving skills and troubleshooting abilities.
Knowledge of export regulations and procedures a plus.
Ability to work cooperatively as a member of a team - position will interact with multiple operational units
Detail oriented and good time management skills
Excellent interpersonal, written, and oral communication skills with ability to articulate with accuracy and detail
||Buffalo, NY |