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Title: Design Quality Engineer
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration – Permanent
- Pay rate: $75-85K
- Job Location: Marlboro, MA
- Job# bh12411
- Design Quality Assurance Engineer
- The Design Quality Assurance Engineer is responsible to support Design Quality Assurance activities in support of Product Development and Life Cycle processes including design controls, quality planning, risk assessments/analysis/management.
- General Summary
- The Design Quality Assurance Engineer is responsible to support Design Quality Assurance activities in support of 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 this position you will be the contact person for quality related issues for R&D. Additionally, you will work closely 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 qualifications as well as validation protocols, reports, and participate in other QA tasks as needed.
- Essential Job Functions:
- 1. Responsible for Review and Approval of protocols and reports, SOPs and Master Documents pertaining to Research and Development activities and its compliance.
- 2. Responsible to provide Quality support at various stages of Product Development.
- 3. Responsible for the co-ordination with internal and external customer and R&D team to resolve Development related product quality issues.
- 4. Responsible for review of Product Development Reports and relevant data.
- 5. Coordinate and support for release of Pilot batches for studies.
- 6. Ensure FDA and other regulatory knowledge and experience is applied to risk assessments
- W7. Work with manufacturing engineering to ensure necessary process controls are in place for design changes.
- 8. 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
- 9. 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
- 10. Develop statistically sound sampling plans and perform data analysis
- 11. Understand and help implement global processes of the QMS related to Design Controls
- 12. Work with product development teams and other QEs to assure compliance to the QMS
- 13. Analyze complaint data, post market surveillance and risk analysis to assist in the identification of potential product improvements based on sound engineering principles.
- 14. Participate in Corrective and Preventive Actions (CAPA) and QMS continuous improvement projects as they relate to Design Assurance and Complaint Review Board Process
- 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
- 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, Service Max and Agile is a plus
- Must be able to communicate appropriately and adequately to all management levels, including group presentation experience
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
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