Summary
The Manager of Quality Assurance and Regulatory Affairs works closely with the Global HCTM/QMM to ensure a compliant and efficient medical device quality system is maintained in Utica, New York and Vienna, Virginia which will easily withstand audits by regulatory agencies and third parties.
This position is responsible for managing the quality systems requirements of the Company. The individual must work well in a rapid paced environment in the areas of quality control, quality assurance, validation, compliance, and regulatory affairs. The position requires the candidate to be flexible, and have the ability to coordinate many projects at a time. Demonstrated experience with development, implementation and management of company-wide Quality Systems. The position plays a key cross-functional liaison role with Product Development, Sales, Marketing, and Manufacturing, assuring compliance to all applicable regulations.
Hands-on experience with implementing change in an organization. Highly developed written and oral communication skills. The position is responsible for assuring compliance to applicable medical device domestic and international standards and laws, including US FDA QSRs, EU Medical Device Directive, ISO13485:2003, CMDCAS, and other ISO/EN standards, and AAMI/ANSI standards.
The Manager of QA/RA is a strong advocate of not only medical device quality system and process excellence, but best industry practices from all allied areas. Familiarity with FMEA and Six Sigma is important but more important the wisdom to judiciously use relevant metrics and process improvements. Verification and Validation in both medical device product development and process, will not only be familiar but are sujects which the Manager can analyze and explain in clear and concise terms.
Will coordinate the regulatory approval process for the region with the Global Regulatory Affairs Specialist, including the post-approval regulatory suport for marketing activities, medical device clearances 510(k)s, Technical Files, etc), and reporting of medical device complaints and recalls are all within the scope of responsibility.
Key Responsibilities
1. Maintain up-to-date knowledge of domestic (USA)d international quality system regulations and standards
2. Develop and direct Quality Systems Program including: Complaint Investigation and MDR System, Vigilance System for the European Community, Corrective and Preventive Action Program, Monitor Production & Process Controls, Ensure Effective Calibration & Preventive Maintenance systems, Provide Guidance for Qualifications and Validations, Provide Guidance on Design and Process Risk Management activities, Statistical Applications Program Product Release - Failure Investigation Program, Capable of representing Quality Systems in Product Project Meetings, Manage the Design History Files for product development activities
3. Supervise Document Services and staff (when applicable)
4. Supervise Training records and staff (when applicable)
5.Administer Employee Performance Evaluations (when applicable)
6. Provides supplier Quality System assessments and maintains supplier audit program
7. Conducts or manage internal audits, or makes arrangements with 3rd party auditors to perform internal audits
8. Establish and generate management reports regarding quality activities
9. Identify and implement continuous process improvement methodologies and tools to effect efficiency change and cost reduction
10. Responds and resolves general quality issues
11. Follow established quality system procedures
12. Assist in maintaining the established quality system under the CMDR, EU MDD, ISO13485 and 21 CFR 820 (QSR) requirements
13. Complete training in accordance with company procedures
14. Perform other activities, as required
Supervisory Responsibilities
This is a senior level position This position may require supervision of other quality specialist positions.
Knowledge and Skill Requirements
1. 5 or more years of quality experience in a medical device company, with 3 years of direct management and quality assurance experience
2. Must have thorough understanding of US FDA Quality System Requirements, ISO/EN 13485:2003, EU MDD and Canadian CMDCAS requirements
3. Ability to think strategically and plan for a 3-5 year time span to sustain growth
4. Must have experience performing internal process and system audits
5. Individual must be hands-on, results-oriented manager and leader, who is a strong team player, excellent communicator, and comfortable in an entrepreneurial environment
6. Requires strong written, oral, interpersonal, group, and telephone communication skills
7. Position works closely with executive management, engineering, other departments within the company, and contract manufacturers
8. Demonstrated ability to deal with unresolved situations, frequent changes, delays or unexpected events
9. Must be able to follow established policies and procedures, create new procedures, and comply with regulatory requirements
10. Ability to recognize problems, recommend and implement solutions
11. A logical and organized thought pattern is required
12. Computer skills are needed, with experience using Microsoft Access, Word, Excel, PowerPoint, and software programs
13. Knowledge of statistics and application of statistical methods and analyses is recommended, as the position requires trend analyses is recommended, as the position requires trend analysis to be performed
14. Experience working with computer-based, software controlled medical devices is preferred
15. The ability to communicate articulately, both verbally and written
Education
Bachelor's Degree in the natural or biological sciences, or equivalent BS/MS IE, ME, QA, BME. CQE, RAC, RAB, or any other quality and regulatory certificates a plus.
