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
As an integral member of the quality team, the Design Quality Assurance Engineer will provide Quality representation and guidance to R&D in supporting projects for new and existing products in accordance with applicable regulatory requirements. This person partners with R&D, Regulatory and Operations in the development, verification, validation and approval of Cutera products.
Foster a ‘strong right first time’ compliance culture.
Duties and Responsibilities:
- Serve as a quality representative to R&D for all design controls and product development activities.
- Ensure new products are developed per state-of-the-art standards.
- Support design verification and validation, and review V&V test plans and reports to ensure the design outputs meet both system and customer requirements.
- Participate in design and phase gate reviews at all phases of product lifecycle process.
- Partner with internal customers to perform risk management activities including hazard identification, hazard analysis, DFMEA and risk mitigation consistent with ISO 14971.
- Provide guidance to the software team on the application of IEC 62304 to all Cutera software.
- Work closely with the NPI team to transfer design into manufacturing.
- Collaborate with cross-functional teams including R&D, Manufacturing, Operations, Service to develop Device Master Records.
- Audit DHFs to ensure compliance with Design Control Procedure.
- Initiate, review and approve Document Change Orders and Engineering Change Orders.
- Act as a technical resource to troubleshoot problems originating from customer complaints.
- Participate in internal and external audits (FDA, Notified Body, etc.)
- Develop standard operating procedures for processes in design controls as required.
- Other duties as assigned.
- Bachelor’s degree in Science or Engineering or related discipline.
- Minimum 3-5 years’ experience working in a highly regulated medical device environment.
- Detail-oriented with the ability to lead multiple projects and activities assigned.
- Excellent organizational skills, planning, communication and follow up skills.
- Proficient in Microsoft suite, SPC tools.
- Ability to work in a fast-paced, team-oriented environment with strict deadlines.
- Strong knowledge of design controls in medical device.
- Working knowledge of applicable medical device regulations such as 21 CFR 820, ISO 13485:2016, ISO 14971:2019, EU MDR and MDSAP.
- Experience with IEC 60601-1, IEC 62304 and IEC 62366 requirements.
- Significant attention to detail and highly organized
- Demonstrated oral, presentation and technical writing skills
- Strong analytical 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.
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City: Brisbane, CA, US
Employer reference: REF468R