Our client is seeking an experienced Quality Manager for a brand new facility within an established ISO 13485 regulated company. They are building a brand new, world class facility in Winston. You will be responsible for creating, developing and shaping the future of the quality team. It's a fantastic opportunity to take control of a project and further your career.
The role:
Direct and coordinate major quality projects provide significant guidance and approval regarding technical strategies and approaches.
Develop and monitor department budgets to maximize investments, increase efficiencies and ensure the quality of our product.
Drive the development of department tools and methodologies.
Establish long-range objectives and specifying the strategies and actions to achieve them (i.e. develop policies, procedures, methods, and/or standards).
Manage staff, preparing work schedules and assigning specific duties and tasks.
Coaching and developing your team - identifying the developmental needs of others and coaching, mentoring, or otherwise assisting/helping others to improve their knowledge, skills, attaining career goals.
Motivates individuals to achieve results, and recruits and maintains a high quality team.
Ensures processes needed for the QMS are established, implemented, and maintained.
You'll manage the following functions and tasks directly or through the team:
Management Review
Supplier Quality / SCAR
Calibration
Non-conformance
Document Control
CAPA
External QMS Audits (Customer; Notified Bodies)
Corporate Internal QMS Audits
In-process Inspection/Other duties and assignments as directed by Management
Education and/or Experience:
Degree in related discipline and 5+ years' experience in Medical Device / ISO13485 environment