Design Quality Assurance Engineer II

*REMOTE POSITION - Massachusetts/New England based preferred.

Company Overview:

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.

General Summary

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.

Primary Responsibilities

• 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 activities.
• Participate in Corrective and Preventive Actions (CAPA) and QMS continuous improvement projects as they relate to Design Assurance and Complaint Review Board Process.
• Ownership of risk management process and risk management files. Updated regularly according to QMS and performing ad-hoc risk reviews as necessary.
• Support of Safety & Compliance testing (IEC 60601) by providing risk and validation documentation and highlighting gaps where appropriate.
• Provide direct support to Regulatory during product submissions by reviewing DHF documents to close submission gaps where possible.
• Ownership of HRA kick-off process & technical investigations due to adulterated product in the field or safety issues.
• Ownership of biocompatibility process including the creation of the Biological Evaluation Plan, oversight of ISO 10993 testing where appropriate, and creation of the Biological Evaluation Report.
• Support of the External Standards process. Acting as an SME for standards where DQA is directly accountable (ISO 10993, ISO 14971, ISO 11135, ISO 11137 etc.) and participating in gap analysis reviews and action plans as applicable.
• Develop and oversee the execution of TMV activities.
• Develop and oversee the execution of CSV activities.
• Represent CSV on software development and deployment teams as the software validation subject matter expert.
• Establish and enforce a Decision Tree for making Validation Change Assessments, and if Validation is required then how the protocol should be constructed.
• Partner with and/or lead business teams and IT to ensure that computerized quality systems are compliant with Candela procedures, FDAs 21CFR11, GAMP 5, and other relevant regulations.
• Act as a core team member on software validation projects across Candela.
• Monitor/Review/Approve Sterilization work conducted for Candela’s existing and future products by third party vendors and ensure compliance to current Candela procedures, ISO 11135, and ISO 11137 requirements.
• Coordinate sterilization qualification for new products and/or changes to existing products.
• Partner with Candela’s external vendors on sterilization validation for radiation sterilized products including dose setting and quarterly dose audits.
• Partner with Candela’s external vendors on sterilization validation for ethylene oxide sterilized products including but not limited to new product qualification, annual revalidations, residual EO studies.
• Other projects as assigned.

Knowledge/Educational Requirements

• Bachelor’s degree in engineering or related field, plus a minimum of 2-4 years of related experience in the medical device or another regulated industry
• Expert understanding of appropriate global medical device regulations, requirements and standards, including Quality Management System (ISO 13485) and Medical Device Regulations (21 CFR 820) is a must
• Expert level understanding of Risk Management (ISO 14971), Biocompatibility (ISO 10993), and EO/Gamma Sterilization (ISO 11135 & ISO 11137)
• Working knowledge of IEC 60601, IEC 62366 (HFE), IEC 62304, and IEC 81001-5-1
• Familiarity with SW and System automated test tools – strong advantage
• Project Management (development of project plans, status meetings, project reporting, etc) and organizational change movement
• Ability to analyze information and come to conclusions based on presented data
• Ability to communicate effectively both orally and in writing
• Self-motivated and ability to manage time working on multiple projects simultaneously
• Demonstrated competency in computer skills: MS office applications, query tools, and enterprise database systems, ServiceMax and Oracle is a plus
• Must be able to communicate appropriately and adequately to all management levels, including group presentation experience

This job description is not all inclusive and is intended to capture a majority of the job functions. Special projects and other tasks may be required by management.