What are the responsibilities and job description for the Manager, Quality Assurance position at Cutera, Inc.?
Position Summary
The individual is responsible for activities that lead to, and maintain compliance to/with Cutera’s Quality Management System and maintains regulatory approval to market devices. Additionally, the individual is responsible for the assessment of device changes for quality and regulatory implications and developing strategies for submissions and maintenance of documentation within the framework of regulatory requirements in an efficient manner.
Duties & Responsibilities
Minimum Requirements & Qualifications:
The individual is responsible for activities that lead to, and maintain compliance to/with Cutera’s Quality Management System and maintains regulatory approval to market devices. Additionally, the individual is responsible for the assessment of device changes for quality and regulatory implications and developing strategies for submissions and maintenance of documentation within the framework of regulatory requirements in an efficient manner.
Duties & Responsibilities
- Manage and maintain Cutera’s Quality System to ensure continued compliance with global regulatory and customer requirements.
- Lead and manage Cutera’s Quality Assurance department and employees to achieve organizational goals and employee development and growth.
- Promote the recognition of quality programs within the company to create a shared continuous improvement mindset across functional departments.
- Prepare and maintain organizational readiness for FDA, ISO and other agency audits of our quality system.
- Lead and manage compliance processes (CAPA, Internal Audit, Material Review board, Supplier Quality) and implement improvements.
- Formulate, document and maintain quality metrics and on-going objectives.
- Serve as a Lead Auditor, develop and manage internal audit systems, address non-conformities from internal and external audits.
- Oversee calibration and testing systems.
- Participate and provide input into the design and development of new products, including risk analysis and quality planning to transition new products to production.
- Participate in supplier qualification and oversight, including perform supplier audits.
- Train and support manufacturing personnel on quality system requirements, and safety and hazardous material handling processes.
- Maintain compliance with FDA, GMP/QSR, Manufacturing process/Work Instructions and ISO 13485.
- Other duties as assigned.
Minimum Requirements & Qualifications:
- Master's or Bachelor's degree in a technical field, or equivalent experience with a minimum of 5 years of experience with Quality System Management for an ISO certified Technology Company (medical device or electronics devices preferred).
- Extensive knowledge of ISO 13485 compliance.
- Experience in quality planning, project management, verification, validation, and process validation.
- Strong organizational skills and high-quality standards
- Hands on ability to lead a group of individuals and various cross-functional project teams on collaborative projects and the ability to work as a member of a team.
- Ability to link functional responsibilities to overall business goals, and to manage and prioritize multiple projects simultaneously.
- Proficient in use of MSWord, Excel, PowerPoint and other technical tools for QMS / PLM management is required.
- Strong writing skills and formatting skills.
- Ability to work well under pressure while managing multiple projects and meeting deadlines.
- Provide detailed reports to Senior Management on critical projects as well as provide quarterly updates to the BoD.
- Ability to read and understand regulations, standards and procedures.
- Good leadership, analytical and interpersonal skills.