Performs a variety of tasks necessary to implement and maintain the Quality Management System including product complaint/feedback, document and record control, internal/external audits, equipment calibration/maintenance, training, product design, and corrective actions. Supports commitment to quality and trains other department personnel on QMS processes and procedures. Responsible for maintaining the safety program including training.
Primary Job Duties
- Assists the Quality Manager with the maintenance and implementation of QMS processes and procedures.
- Interprets and implements quality assurance standards and OSHA safety standards.
- Develops and writes QMS documents and procedures for approval by the Quality Manager.
- Conducts internal audits, evaluates findings and implements appropriate corrective actions.
- Prepares for and participates in external audits and responds to issues.
- Responsible for facility document control program.
- Responsible for the maintenance of the facility maintenance and calibration program.
- Investigates customer complaints and customer feedback.
- Participates in the product design process for new products.
- Analyzes quality data and logs to identify anomalies and trends.
- Assists the Quality Manager with the maintenance and implementation of Safety Program.
- Maintains database on required training, needs and participants.
- Utilizes computer and software necessary for the development of documents and recording of Quality records and data.
- Maintains accurate and complete documentation of all work performed for the establishment of methods and standards.
- Conducts training programs for Quality and in the use of quality processes and tools.
- Conducts training for safety programs.
- Creates QSR reports for review by management.
- Maintains and reviews maintenance and calibration schedules for Quality Control and Applications equipment.
- Responsible for pipet calibration/verification program.
- Maintains inventories of master lots/testing materials for Quality Control.
- Maintains product retain system.
- Assists other departments with procedure development and writing.
- A bachelor’s degree in a life sciences or related discipline and three years of related work experience which includes quality assurance experience preferably in the chemical or diagnostic industry, OR a combination of education and applicable work experience.
- Previous related work experience that provides the knowledge of and skill for technical writing.
- Good written and verbal communication skills
- Good planning and organizational skills and the ability to work independently.
- Good understanding of General Manufacturing Practices in the medical device industry.
- Requires the ability to work on more than one ongoing project at one time.
- Knowledge of ISO requirements and audits.
- Knowledge of OSHA safety standards.
- ISO Audits and Requirements: 2 years (Preferred)
- Laboratory: 2 years (Preferred)
- Quality Assurance: 2 years (Preferred)
- Bachelor’s (Preferred)