Quality Assurance Manager I

About the role

Are you looking for a challenging and rewarding opportunity in a fast-paced environment? Do you take an analytical approach to design complex and innovative solutions that exceed customer expectations and directly impact a growing business? Do you enjoy being part of a passionate team that works with stakeholders from across the business to create and implement the best solutions for our customers?

Responsibilities

• Manage and coordinate all aspects of quality assurance activities with various levels of risk and complexity within a variety of scopes across a single site / multiple sites and / or single or multiple customers.
• Confirm requests for quality support from the site and communicate policies and procedures.
• Act as an expert regarding selected governmental regulations for the site(s).
• Serve as a proactive liaison with customer for quality assurance across site(s).
• Develop, manage, and oversee site quality resources.
• Support global and cross-sector Quality and Regulatory initiatives, as required.
• Support validated processes as applicable for regulated hardware, equipment, and software systems.
• Oversee the maintenance and continuous improvement of the overall quality system, including management review, CAPA management, internal quality audits, quality self-assessments, change control, document control, and standard operating procedures/work instructions.
• Oversee the licenses, permits, and registrations process.