About Us: Cutera 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. Read more at www.cutera.com

Position Summary:

As an integral member of the quality team, the Quality Systems Engineer is responsible for ensuring compliance of the Quality Management System to all applicable regulations and standards. This role is responsible for owning and implementing the post market surveillance system at Cutera.

Foster a ‘strong right first time’ compliance culture.

Duties and Responsibilities:

• Ensure Cutera Quality System conforms to 21 CFR Part 820, ISO 13485:2016, EU MDR, MDSAP and all other applicable regulatory requirements.
• Implement and maintain the post market surveillance system in the organization.
• Lead the PMS group to update PMS plans, gather post market data and construct Periodic Safety Update Reports for applicable device families.
• Perform analysis of current post market processes, draw conclusions, and make appropriate recommendations.
• Analyze, aggregate, and contextualize post market data trends to present it to the Quality Review Board.
• Lead recurring Quality Review Board meetings and initiate discussions around potential safety signals.
• Work with EU MDR inter-departmental core team to develop and maintain records for EU MDR requirements.
• Collaborate with cross-functional teams and compile data to present during Management Review meetings.
• Support external audits including FDA inspections and notified body audits, as required.
• Other duties as assigned.

• Bachelor’s degree in Science or Engineering or related discipline.
• Minimum 2-4 years’ experience working in a highly regulated medical device environment.
• Strong working knowledge of applicable medical device regulations such as EU MDR, 21 CFR 820, ISO 13485:2016, ISO 14971:2019 and MDSAP.
• Lead auditor certification preferred.
• Driven team player with the ability to lead multiple projects and activities assigned.
• Excellent planning, collaboration, and communication skills.
• Proficient in Microsoft Office suite, SPC tools.
• Ability to work in a fast-paced, team-oriented environment with strict deadlines.
• Significant attention to detail and highly organized.
• Demonstrates oral, presentation and technical writing skills.

All your information will be kept confidential according to EEO guidelines.

If you are ready to become part of our spectacular, growing, and FUN company, then apply today!

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.

Applicants responding to this posting must be able to provide proof of eligibility to work in the United States. Competitive salary, benefits, ESPP and stock options. Cutera is an Equal Employment Opportunity Employer.

If you are ready to become part of our spectacular, growing, and FUN company, then apply today!

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.

Applicants responding to this posting must be able to provide proof of eligibility to work in the United States. Competitive salary, benefits, ESPP and stock options. Cutera is an Equal Employment Opportunity Employer.