Job DetailsJob Location: BRISBANE, CA 94005Position Type: Full TimeSalary Range: $120,000.00 - $150,000.00 SalaryPosition Summary: The individual is responsible for activities that lead to, and maintain compliance to/wit…
Skills: Quality System Management, ISO 13485 Compliance, CAPA, Internal Auditing, Risk Analysis
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$120k–$150k/yr
Full-time
bachelor degree, postgraduate degree
Posted 14d ago
~40 hrs/week
Responsibilities
Manage and maintain the Quality Management System to ensure global regulatory compliance and market approval for devices. Lead the Quality Assurance department, overseeing compliance processes such as CAPA, internal audits, and supplier quality.
Requirements
Requires a Bachelor's or Master's degree in a technical field with at least 5 years of experience in Quality System Management for an ISO certified company. Must possess extensive knowledge of ISO 13485 and proficiency in QMS/PLM management tools.
Full job description
Job DetailsJob Location: BRISBANE, CA 94005Position Type: Full TimeSalary Range: $120,000.00 - $150,000.00 SalaryPosition 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
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.
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.
Cutera, Inc. is a leading global aesthetics device company with a comprehensive product portfolio and a global distribution footprint. We are a fast-paced, high-tech medical device company looking for the right person to help grow our business and reap the rewards of doing it! We hire the best people and provide them the best comp and benefits to help improve their lives. Learn more on our company website.
Offices: 3240 Bayshore Blvd., Brisbane, CA 94005, US · 15/1 O'Connell St, Sydney, New South Wales 2000, AU · Boulevard Auguste Reyers 80, Schaerbeek, Brussels Region 1030, BE · 1, Rue Georges Charpak, Lieusaint, Ile-de-France 77127, FR · Prielmayerstraße 3 d, Munich, Bavaria 80335, DE
Medical DevicesAesthetics ProceduresDermatologyCosmetic ProceduresPlastic SurgeryLaser technologiesLight technologiesRF energy based technologiesLaser Hair RemovalLaser Tattoo Removal
How much do Science & Research jobs in California pay?
Based on 11631 listings with disclosed salaries, most science & research jobs in California pay between $103k–$250k per year. Individual offers vary with seniority, company size, and specialization.
How many Science & Research jobs are open in California right now?
There are currently 18,434 open science & research positions in California listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Science & Research roles in California?
Companies currently hiring include Applied Materials, Northrop Grumman, Apple, Google, Northrop Grumman Mission Systems, Inc., among others. Browse the listings above to see every active employer.
Are there remote or hybrid Science & Research jobs in California?
Yes — 3905 of the 18434 open science & research positions offer remote or hybrid work (998 remote, 2907 hybrid).
How do I apply for Science & Research jobs in California?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.