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Responsible for directing all Quality Assurance, Regulatory Affairs, and Quality Control related activities. Oversees the implementation and maintenance of Quality System insuring compliance with various regulation requirements or/and programs such as FDA, cGMP, ISO 9000, and state agencies. Develops and implements strategies for product submissions and registrations to enhance business growth. Acts as Company representative and interacts with regulatory agencies. Conducts both internal and external audits for continual improvements. Supports applicable regulations including ISO, Local, state, and/or Federal requirements.
DESCRIPTION OF POSITION RESPONSIBILITIES:
- Develops, implements, and maintains quality systems for the Company.
- Acts as representative of the Company for all inspections/auditing by various regulatory agents.
- Determines headcount requirements for Quality Systems.
- Development of long-range Quality plans.
- Ensures documentation system is compliant with regulatory agencies.
- Ensures the operations are in compliance with various regulatory requirements and development of long range Quality plan.
- Develops and achieves the budgets for the quality and regulatory affairs departments for the effective operations.
- Develops and implements strategies for product submissions and registrations.
- Identify and analyze opportunities for continual improvements in product/service quality, customer satisfaction, and company profitability.
- Conducts external and internal audits and provide the audit reports for continuous improvements.
- Provides quality system related training to employees
- Advises senior staff of regulatory trends and actions that must be incorporated into business and strategic planning.
- Responsible for performing assigned tasks in accordance with applicable safety regulations and instructions, as well as correcting unsafe work habits and practices and/or bringing to the attention of the Safety Team or a supervisor any practice or condition that may be detrimental to the safety and health of the employees. You also have a responsibility to cooperate in all safety or health-related programs and assist in solving safety and health problems. Violations of safety directives and procedures will be handled in accordance with the established Company disciplinary process.
- Performs other duties as assigned.
RELATED BUSINESS/ TECHNICAL SKILLS, KNOWLEDGE, ABILITIES:
- Accuracy and detail orientation extremely important.
- Ability to use independent judgment and to work independently.
- Solid organizational skills and time management skills.
- Excellent verbal and written communication skills.
EDUCATION AND EXPERIENCE REQUIREMENTS:
Requires a Masters degree in Science or equivalent to include a minimum 10 years experience in all aspects of Medical Device or Healthcare Industry. Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Ensure budgets and schedules are met. Regularly interacts with senior management on matters concerning several functional areas, divisions, and/or customers. Requires the ability to change the thinking of or gain acceptance of others in sensitive situations. Able to work with limited supervision and be detail-oriented.
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