Senior Quality Engineer

Location:
Marlborough, MA - Hybrid, required 3 or 4 days in office in

Duration: 12+ Months

This role ensures that Client 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
• 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 as well as Client policies
• 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
• Perform other duties as assigned

Required

Work Experience:

• 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

Preferred

Work Experience:

• 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)

Knowledge:

• Experience with quality management system development, Design Controls, and risk management

Skills:

• 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

Business Process Skills

• Able to effect Quality Improvement through problem solving skills and knowledge of quality tools
• Able to lead and drive change
• 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, journal/document review)
• Walking or standing within the office area to operate other office equipment
• 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

Bachelor’s Degree (Required)

• ASQ Certification preferred
• Regulatory Affairs Certification (RAC)

Experience in Medical Devices and/In Vitro Diagnostics (IVD) design and development with a strong focus on design control and risk management is preferred