Director of Quality
Brisbane, CA, USA | Cutera, Inc.
Job Description:78 people have viewed this job
The Director of Quality will lead the implementation of the company’s quality management system. He/she will work collaboratively with project leadership and other team members to develop, coordinate, and own the quality and compliance elements of a project. These will include all applicable quality assurance and quality control activities related to product planning, design and development, engineering builds, clinical builds, and transfer to manufacturing.
Duties and Responsibilities:
Build and drive a Quality vision and strategic objectives that aligns with the company’s corporate quality mission statement.
Lead and inspire a strong quality team by hiring and developing strong quality leaders, establishing and actively managing performance expectations, and providing development and training opportunities.
Coach and motivate the Quality Assurance team with a mix of ISO 13485, EU MDD, and GMP (21CFR820).
Drive operational excellence by effectively using continuous improvement skills and tools to prioritize and drive projects and improvements/standardization across the network to improve Quality service levels, reduce costs, and align with strategic objectives.
Establish QA/QC priorities and key objectives to reduce turnaround time, the cost of poor quality and improve the compliance to regulations and the site Quality Management System.
Ensure global training is effective and operates within the required regulatory guidelines.
Ensure effective management of the network / site Quality Management System including assuring effective management reviews, complaint handling, CAPA system, change control, supplier management, calibration maintenance, process validation, internal auditing, R&D transfers, and manufacturing area support.
Drive the continuous improvement of Quality Management Systems, including assuring effective management reviews, complaint handling, CAPA system, change control, calibration maintenance, internal auditing, R&D transfers, validation, and manufacturing area support.
Support product testing according to IEC 60601-1 and IEC60601-1-2 standards.
Support the commercialization of New Product Introductions by working with product development team members.
Collaborate with the Global Regulatory organization to ensure compliance to applicable regulations.
Maintain compliance with FDA, GMP/QSR, Manufacturing process/Work Instructions and ISO 13485.
Other duties as assigned.
Bachelor’s degree in Science or Engineering Disciplines, or equivalent experience
ISO 9000/2000 or ISO 13485 auditor training.
Experience in quality planning, project management, verification, validation, and process validation.
A minimum of 10 years of Quality experience within the Medical Device industry.
Decisive leader who’s successfully managed larger teams in a highly matrixed organization.
Demonstrated experience working with external customers and commercial teams creating strategies that address customer needs and product specification.
Proven experience with Project Management and Lean Six Sigma methodology.
Previous experience supporting Medical Device New Product Introductions preferred.
Customer focus – Puts the customer at the front of every decision, including work prioritization, resource investment, and process improvement
Quality systems – Ability to practically implement strong quality systems that provide only the necessary controls as defined by marketplace and our customers
Transformation – Understand the levers necessary to elegantly transform a traditionally research based business to a mixed research and clinically focused business
Building a team – Builds a strong team and has a compelling capability to marry strategy, organizational structure, and talented leaders
Operational execution – Clear view of the mechanisms necessary to manage a global quality organization efficiently and effectively
Strong organizational skills and high quality standards
Ability to travel up to 25 percent.
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