- Establishes quality and reliability standards by studying product and consumer requirements with other members of management and with production operators, technicians, and engineers.
- Establishes product quality documentation system by writing and updating quality assurance procedures.
- Maintains product quality by enforcing quality assurance policies and procedures and government requirements.
- Completes quality assurance operational requirements by scheduling and assigning employees; following up on work results.
- Maintains quality assurance staff by recruiting, selecting, orienting, and training employees.
- Maintains quality assurance staff job results by coaching, counseling, and disciplining employees; planning, monitoring, and appraising job results.
- Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.
- Achieves financial objectives by preparing the quality assurance budget; scheduling expenditures; analyzing variances; initiating corrective actions.
- Contributes to team effort by accomplishing related results as needed.
- Implementation and management of Quality System
- Responsible for FDA and government regulations
- Ensure that all requirements are met to pass quality audits from suppliers or regulatory authorities.
- Handling customer complaints for all products sold in North American countries and MDR reporting.
- Contact person to correspond with FDA about RA, QMS, PMS, MDR reporting and Recall matters.
- Other duties as required by supervisor.
1. People Management
2. Analyzing Information
3. Reporting Research Results
4. Technical Understanding including FDA 21 CFR 820
5. Promoting Process Improvement
6. Developing Standards
7. Managing Processes
8. Manufacturing Methods and Procedures
9. Dealing with Complexity
10. Problem Solving
11. Process Improvement
- 1. Knowledge of quality systems and regulatory affair
- 2. Ability to travel 10% of the time
- 3. Previous R&D medical device experience a plus
- 4. Excellent verbal and written communications skills with good command of English grammar and vocabulary
- 5. Good organization skills and ability to multi-task
- 6. Ability to work with mathematical concepts such as percent change, profitability, margin analysis, fractions, ratios, etc.
- 7. Extensive experience with MS office suite and internet
- 8. Strong and fast learner
- 9. RAPS（Regulatory Affairs Professionals Society）member is a plus
Physical Requirements and working environment:
This position requires the employee to frequently sit. In addition the employee is occasionally required to stand, walk, use hands and fingers and reach with hands and arms.
Must be able to occasionally lift and /or move up to 15 pounds.
Ability to read and analyze hard written copy and information on a computer screen, in addition requires vision abilities such as close vision, peripheral vision, depth perception, and the ability to adjust focus.