The Design Quality Assurance Engineer is responsible for supporting Design Quality Assurance activities in Product Development and Life Cycle processes including design controls, quality planning, risk assessments/analysis/management, design reviews, approval of test methods, design and process verification and validation test plans and reports. You will play an important role in reviewing and approving design changes and in developing/ improving risk-based product controls.
In the position you will be the contact person for 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.
Essential Job Functions
Responsible for Review and Approval of protocols and reports, SOPs and Master Documents pertaining to Research and Development activities and its compliance.
Responsible to provide Quality support at various stages of Product Development.
Responsible for the cooperation with internal and external customer and R&D team to resolve Development related product quality issues.
Responsible for review of Product Development Reports and relevant data.
Ensure FDA and other regulatory knowledge and experience is applied to risk assessments
Work with manufacturing engineering to ensure necessary design controls are in place for design changes.
Act as an effective 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 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
Participate in analysis of complaint and post market surveillance data and risk analysis to assist in the identification of potential product improvements based on sound engineering principles.
Participate in Corrective and Preventive Actions (CAPA) and QMS continuous improvement projects as they relate to Design Assurance and Complaint Review Board Process
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
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 Agile 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.
Candela Corporation is proud to be an Equal Employment Opportunity and Affirmative Action Employer and is committed to creating a diverse and inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.