Design Quality Assurance II

Candela Corporation is a leading global aesthetic device company with a comprehensive product portfolio and a global distribution footprint. We are the market leader in the development, and distribution of medical and aesthetic laser and light-based technologies. The Company’s technology enables physicians to provide advanced solutions for a broad range of medical-aesthetic application including hair removal, wrinkle reduction, tattoo removal, improving the skin’s appearance through the treatment of benign vascular and pigmented lesions, and the treatment of acne, leg veins and other common indications.

The Company is headquartered in Marlborough, Massachusetts, USA, with an additional R&D facility in Yokneam, Israel and commercial locations across Asia Pacific, and Europe. Products are sold directly in 18 countries worldwide and are supported by capital sales, field service, clinical education, technical support and marketing development organizations. Candela maintains contracted distributors in over 60 other countries.

Design Quality Assurance (DQA) is accountable for maintaining expertise in Design Controls and ensuring the validation processes are operated in a way to achieve product performance/reliability targets in the field. The Design Quality Assurance Engineer (DQE) is responsible for supporting

DQA activities in Product Development and Life Cycle processes including design controls, risk assessments/analysis/management, design reviews, test method validation (TMV), and approval of V&V test methods/plans/reports. You play an important role in reviewing and approving design changes, supporting V&V testing, and in developing/ improving risk-based product controls. The Design Quality Assurance Engineer (DQE) also is responsible for overseeing Computer System Validation (CSV) activities and creating/maintaining the Sterilization Process.

You are the contact person on quality related issues for R&D. Additionally, you will closely work together with QA-colleagues, R&D, project leads and production. You will issue QA documents with sponsors, review the analytical methods/ results, production records, and qualification as well as validation protocols and reports and participate in other QA tasks as needed.

• Review and Approval of protocols and reports, SOPs and Master Documents pertaining to Research and Development activities and its compliance.
• Provide support as defined by SOP’s during/after Product Development projects.
• Lead efforts with internal and external stakeholders to resolve all product quality issues.
• Report, assess, investigate, and conclude/resolve all anomalies/trends in monthly product quality reviews. Lead analysis of post-market data to highlight impactful recommendations for improvement to product quality performance.
• Review and approval of Product Development Verification & Validation Protocols & Reports (and relevant data) to ensure testing coverage of all product & compliance requirements.
• Apply FDA and other regulatory expertise to risk assessments.
• Work with CMOs and supplier quality engineering to ensure appropriate design control mechanisms are in place for design changes and that proper monitoring/control mechanisms are established to ensure all product leaving the factory meets specification.
• Operate effectively as a team member in the execution of Quality functions in compliance with FDA QSRs (Design Control, CAPA, etc), ISO 13485 and other national and international quality and regulatory requirements and standards.
• Contribute to the design, development and implementation of product assurance plans providing feedback to corrective and preventative actions to engineering, manufacturing, service and field operations and supplier performance.
• Develop statistically sound sampling plans and perform statistical data analysis.
• Understand and help implement global processes of the QMS related to Design Controls.
• Work with product development teams and other QEs to assure compliance to the QMS.
• Use complaints, post market surveillance data, and risk analysis to identify product improvements and provide these as inputs to relevant design…