Supervision (May supervise any or all of the following): Quality Technicians, Quality Supervisors, Quality Engineers.
The incumbent is responsible for working with Production, Sales, Support Services and management representatives to facilitate ongoing quality improvement activities in support of the Company’s goals and customer quality requirements. Ensures that appropriate quality controls are in place to conform and comply with ISO operating standards as well as OTC pharmaceutical and medical device manufacturing.
- Implement and maintain quality systems and programs to ensure compliance with internal and customer defined quality standard requirements.
- Evaluates and advises on the impact of long range planning, introduction of new programs/strategies and regulatory interaction as such applies to ISO operating standards.
- Implement and maintain meaningful product and process quality management systems and summary reports for the manufacturing and support process. Provides corresponding reports for management review on a monthly basis.
- Ensure product consistency by developing and maintaining an effective process control system that includes writing and conducting product and process capability studies for new equipment and purchased raw materials and finished products.
- Identifies critical process issues/concerns and implements appropriate monitoring where applicable. Takes the necessary corrective action in a timely, efficient and supportive manner conferring with other employees as necessary to achieve optimum resolutions whenever and wherever necessary.
- Ensure that all required employee’ training is completed as required by the ISO operating standards. Maintains appropriate training records for all employees as such relate to ISO standards and operating requirements.
- Review and audit a documentation system that includes operating procedures, product specifications and raw material specifications.
- Coordinate all external audits required of the Company’s quality assurance program.
- Develop and maintain all ISO operating standards.
- Develop and maintain credibility for the Quality Management Function by providing timely and accurate analysis of product flow and customer issues/concerns that will assist senior management representatives in managing their assigned responsibilities.
- Enhance and/or develop, implement and enforce Quality Management policies and procedures of the organization by way of systems and other means that will improve the overall operation of the Company.
- Assess employee talent and capabilities.
- Performs other related duties as assigned or requested.
Job Knowledge & Skills
- Bachelors Degree with 5 to 7 years related experience or equivalent combination of education and experience.
- Medical Device background with thorough understanding/experience with FDA compliance preferred.
- Applied knowledge of cGMP.
- Audit experience and competence.
- Must have demonstrated leadership skills as well as communication skills with all levels.
- Knowledge of Quality Management systems and planning techniques.
- Advanced ability in working with MS office.
A little about us:
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