Director, Quality Engineering
Position Overview
Lead Quality Engineering group to provide support for new product development, product design improvements and the enhancement of quality system compliance. Provide strategic direction for department activities based on company goals and objectives. Provide guidance on quality related topics to senior management in Quality, Manufacturing, R&D and Regulatory Affairs. Develop and implement company quality assurance processes to accommodate the growth of the company. Job duties:
- Develop and implement strategic objectives for department based on company goals and objectives.
- Lead Quality Engineering group that supports the development of new medical devices.
- Provide expertise and instruction in technical aspects of quality assurance including risk analysis, design verification, design validation, process validation, test method validation, and data analysis.
- Form and foster partnerships with management in other departments including Quality, Manufacturing, R&D and Regulatory Affairs. Establish and lead programs that enhance interdepartmental collaboration to achieve corporate innovation goals.
- Lead efforts with management in multiple departments to ensure corporation complies with US FDA regulations and international requirements for the development and manufacture of medical devices. Enhance department practices to ensure compliance with company procedures associated with product development and manufacturing.
- Ensure adequacy of Quality Engineering staff by providing leadership, appropriate assignments, individualized training, mentorship, performance assessment, and performance enhancement of staff where needed. Manage resource allocation.
- Develop Quality department staff. Identify and develop associates with the potential to advance into leadership roles.
- Define department goals and strategy for quality support activities associated with the development of medical devices.
- Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
- Perform additional duties as assigned
- Bachelor’s degree in science or engineering.
- A minimum of twelve (12) years of professional engineering experience in the medical device industry.
- A minimum of five (5) years of management responsibility.
- Strong experience in the design, manufacture, and distribution of medical devices.
- Strong experience in design control for medical devices.
- Excellent written and verbal communication skills.
- Proficient computer skills including MS Office (e.g., Word, Excel, Teams, Outlook, etc.) and Minitab.
- Advanced degree in a technical discipline.
- Excellent working knowledge of design control process for medical devices.
- Excellent working knowledge of statistical analysis techniques and validation requirements.
- Strong interpersonal and management skills.
- Strong working knowledge of US and foreign regulations related to: the design, manufacture, and distribution of medical devices and Quality systems and other standards for the medical device industry.
- Experience participating in FDA and notified body inspections, especially in discussions related to design control activities.
- Advanced abilities at reading and preparing technical documentation.