Connexion Systems & Engineering, a Boston based IT and Engineering Solutions Company immediately seeks individuals with the following skills:
Date Posted: 4/5/2019
Hiring Organization: Connexion Systems & Engineering
Job Title: Design Quality Assurance Engineer
Industry: Medical Device
Location: Waltham, MA 02454
Employment Type: Full Time, Permanent
Pay Range: 100-110K
Design Quality Assurance Engineer – Medical Device
The Sr./ DQA Engineer is responsible to lead Design Quality Assurance activities in New Product Development and Sustaining efforts across the company.
The Senior Design Quality Assurance Engineer is responsible to lead 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 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.
- 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 co-ordination 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.
- Coordinate and support for release of Pilot batches for studies.
- Ensure FDA and other regulatory knowledge and experience is applied to risk assessments
- Work with manufacturing engineering to ensure necessary process 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
- Analyze complaint data, post market surveillance and risk analysis to assist in the identification of potential product improvements based on sound engineering principles.
- Lead 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 5 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
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ConneXion Systems & Engineering
490 Boston Post Road
Sudbury, MA 01776