Oversees, directs and Manages activities of Team Members engaged in: Quality Assurance, Quality Control, Quality Engineering, Regulatory Compliance, Document Control and Records, Supplier Quality Assurance and by performing the following duties personally or through subordinate Management.
Principal Duties and Responsibilities
- Directs, oversees and manages the quality assurance departments to ensure the development of high quality products, the production of products to meet quality specifications, and ensure compliance with quality regulations
- Oversees Quality Engineering to ensure new products meet all quality specifications.
- Directs all efforts related to Quality System auditing whether internal or third party.
- Serves as the management representative for Quality Systems and Official Correspondent to FDA.
- Overseas efforts of Team Members engaged in the analysis of reports of complaint and nonconforming materials/processes data and trends. Coordinates and monitors corrective/preventative actions for appropriateness/effectiveness while considering nature of complaints and company interests and policies. As Management Representative, elevates appropriate information to executive level.
- Reviews governmental rulings to determine changes in legal stipulations and probable effects on company activities. Actively participates in and influences standards setting by groups/trade associations/ regulatory advisory groups.
- Interfaces with consultants on legal and regulatory matters. Proactively influences business to avoid liability.
- Ensures Quality Assurance participation in all due diligence and product development teams.
- Attend and contribute to Design reviews in conjunction with assigned projects.
- Directly supervises management Team Members engaged in Regulatory Compliance, Quality Assurance, Quality Control, and Document Control, Software Quality Systems, Quality Engineering and Supplier Quality.
- Carries out supervisory responsibilities in accordance with the organization's policies and applicable regulations. Responsibilities include interviewing, hiring, and developing employees; planning, assigning, and directing work; reviewing performance; providing appropriate rewards and recognition. Ensuring team members receive appropriate feedback and corrective action ensuring high standards of performance. Addresses complaints and resolves problems.
- Responsible for Management oversight of Quality systems for functional area in compliance with 21 CFR Part 820, ISO 13485 and other applicable international regulations.
- Responsible for integration of risk management into the quality system in compliance with ISO 14971.
- Performs related duties as required.
Expected Areas of Competence
- Possess a high degree of business acumen
- Outstanding written and verbal skills
- Successful track record managing direct reporting team members and experience working with Team Members across functions/departments
- Broad knowledge of FDA rules and regulations as they relate to medical device manufacturing
- Must be a self-starter, flexible and adaptable
- Possess proven negotiation and conflict resolution skills
- Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community
- Ability to effectively present information to senior management and Team Members
Bachelor’s degree (B. A. / B.S.) or equivalent; plus 10-15 years progressive related experience and/or training; or possess the equivalent combination of education and experience; Masters degree would be a plus. Proven experience in managing several projects simultaneously
Travel may be required 10% of the time.