Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our custom-made devices continue to make a huge difference in the lives of medical professionals and their patients. Our employees are actively involved in the design, engineering and manufacture of technologically advanced medical devices that ensure that we meet our customer’s quality specifications for each product we produce.
This role requires the candidate to lead the oversight and integrity of the Quality System and establishes product quality and compliance strategies. The role also acts as a liaison between the company and various governmental agencies and notified bodies to assure compliance to all quality and regulatory standards.

WHAT YOU’LL DO:

• Provides vision and leadership for quality for the site by determining quality objectives and linking those objectives to company and corporate objectives
• Develops, establishes, and maintains quality assurance programs, policies, processes, procedures, and controls ensuring that performance and quality of products conform to established company, international (ISO), and governmental regulatory standards and agency guidelines, and to ensure customer satisfaction
• Acts as the Quality Systems Management Representative for the site
• Maintains compliance and effectiveness of the Quality Management System
• Represents the business/site to outside regulatory bodies
• Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance and drives implementation for the site
• Manages quality assurance efforts and is responsible for all regulatory compliance issues
• Develops and directs quality programs involving methods, devices, and controls
• Maintains quality system through establishing a system for internal and external inspection of raw materials and finished items purchased and production operations and processes
• Determines and establishes assigned quality organizational structure and supervisory relationships. Coaches, develops, and mentors employees in work group
• Collaborates with cross-functional colleagues to ensure achievement of standards and regulations
• Manages both sustaining and new product introduction quality teams
• Responsible for the overall direction, coordination, and evaluation of quality employees for worksite. Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems
• Other duties may be assigned.

WHAT YOU WON’T DO:

• Feel stuck – we offer great opportunities to advance and learn
• Get bored – we make a high variety of products, so no day is the same
• Feel like a number – we’re a close-knit bunch and always have each other’s backs