Principal Quality Engineer Job Marlborough area,Massachusetts USA,Quality Assurance

Job Description:

This role ensures that our IVD products meet stringent regulatory requirements and quality standards.
The Staff Quality Engineer will lead quality engineering initiatives, support product development and manufacturing processes, and drive continuous improvement in the quality management system.
Develop, implement and maintain quality systems and processes in compliance with FDA CFR Part 820, ISO 13485, IVDR 2017/746, ISO 14971 and other regulations, as appropriate, for IVD products
Conduct hazard analysis and risk assessments for IVD products according to ISO
14971 throughout the IVD product lifecycle
Lead internal and external audits, including preparation, execution, and follow-up to ensure adherence to quality and client standards and regulatory requirements
Oversee corrective and preventive action (CAPA) processes, non-conformance investigations and deviations to resolve quality issues
Collaborate with cross-functional product development teams to integrate quality requirements into product design, verification and validation activities according to Design Controls
Review and approve design control documentation including design inputs, design outputs, verification/validation protocols and reports, and risk management documentation.
Assess and qualify new suppliers in product development and throughout the product lifecycle.
Establish and maintain Design History File for IVD products
Establish, monitor and analyze quality metrics, trends and performance data to identify areas of improvement
Support regulatory submissions and activities for IVD product approvals
Support complaints process (review, process, investigate, trend quality data, etc.) and post-market incident activities.
Support post-market incident activities
Manage post-market incident activities (field action, MDRs, EU incident decision/reporting, field failure trending).
Maintain knowledge of laboratory regulatory requirements, including accrediting bodies, federal, state, and local requirements
Drive continuous improvement initiatives in design control and risk management processes, leveraging industry best practices, lessons learned, and feedback from audits and post-market surveillance data
Stay current with evolving regulatory requirements, standards, and industry trends
Proactively update internal processes, policies and procedures, and training materials as needed
Drive continuous improvement initiatives in design control and risk management processes, leveraging industry best practices, lessons learned, and feedback from audits and post-market surveillance data
Stay current with evolving regulatory requirements, standards, and industry trends
Proactively update internal processes, policies and procedures, and training materials as needed
Follow corporate policies and procedures

Qualifications

Bachelor's Degree (Required)
ASQ Certification preferred
Regulatory Affairs Certification (RAC)
8+ years of experience in Medical Devices and/In Vitro Diagnostics (IVD) design and development with a strong focus on design control and risk management
Experience in working effectively in an FDA-regulated environment
Experience working with IVD products
Analytical mindset with attention to detail and a commitment to integrity, product safety, and Quality
Demonstrated Experience applying medical device regulations (e.g.IEC 62304, FDA 21 CFR Part 803, 21 CFR Part 806, 21 CFR Part 820, ISO 13485, ISO 14971, IVDR, CAP, and CLIA).
Experience with quality management system development, Design Controls, and risk management
Communication (verbal and written), ability to build and manage an effective team, being able to influence others and drive for results, effective presentation skills, problem solving
Demonstrate ability to influence and create change
Strong interpersonal communication skills
Demonstrate strong writing and composition skills
Demonstrate success in motivating team members to reach objectives
Able to effect Quality Improvement through problem solving skills and knowledge of quality tools
Able to lead and drive change
Organization skills
Project and team management skills
Analytical and problem-solving skills
Proficient in Microsoft Word, Excel, and Powerpoint
Able to function in a matrix organization
Flexibility to meet continuously changing priorities and challenges
Requires ability to understand, interpret and apply quality and regulatory requirements.
Prolonged sitting at a desk (i.e., operating a computer, telephone use, document review)
Walking or standing within the office area to operate other office equipment (i.e. printer / fax) or within the laboratory
Required to wear PPE as appropriate when visiting testing locations
Must frequently respond to text/email communications and will be required to be aware of ergonomic principles
May be required to travel by airplane /train or drive long distances
Ability to follow verbal or written instructions and use effective verbal and written communication
Experience in Medical Devices and/In Vitro Diagnostics (IVD) design and…


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