SkyWater is partnering with an esteemed medical device client to recruit a Senior Quality Assurance Manager for their Glens Falls, New York location. Our client, a thriving small company with a commercial product and strong market presence, offers a collaborative culture, significant growth opportunities, and excellent healthcare benefits and stock. Relocation assistance is available.

We are seeking an experienced Quality Manager to oversee daily medical device manufacturing activities, including supplier control, quality inspections, NCR/CAPA/Complaint reviews, and product releases. This role provides direct Quality support for multiple projects, ensuring the development, launch, and maintenance of medical devices.

Responsibilities

• Develop and execute quality and regulatory strategies with the Head of Quality to ensure compliance with US and Global Standards.
• Manage and maintain the Quality Management System at NY location, resolving quality concerns and acting as the Deputy Management Representative.
• Ensure regulatory compliance with FDA, international regulatory authorities, and notified bodies in day-to-day QA processes.
• Oversee product releases, including finished products, raw materials, packaging, and labeling.
• Support the CAPA program, perform audits for the internal program, and support supplier quality with on-site quality audits.
• Investigate customer complaints, ensuring records are maintained, followed up, and closed.
• Provide Quality leadership to development teams and support sustaining engineering.
• Work with the Regulatory Team to implement regulatory strategies for product line extensions, ensuring development activities align with overall regulatory strategy.
• Review and interpret technical data to meet regulatory requirements, document Quality disposition of product/design and process changes.

Desired Skills And Experience

• Bachelor’s degree in a technical or scientific field, preferably engineering (or 15 years of relevant experience in medical device quality and operations)
• In-depth knowledge of regulations and standards, including FDA QSR, ISO 13485, MDR, and other global regulatory requirements
• At least 8 years of relevant experience, with a minimum of 3 years in a managerial role; ideally 10 years in the industry with 5 years in management
• Strong leadership and management skills, with the ability to inspire and motivate teams to achieve results