Senior Quality Engineer

MCRA, an IQVIA business; East Providence (RI); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading medical device company is seeking a Quality Engineer to ensure product quality and safety for new and existing products. The role involves investigating product complaints, managing regulatory compliance, and collaborating with engineering teams. Candidates should possess a Bachelor’s degree in Engineering or Natural Science and have 4–10 years of relevant experience in medical device quality or engineering procedures. The position requires strong knowledge of CAPA, ISO 14971, and proficiency with MS Office and SolidWorks. This is an on-site role in East Providence, Rhode Island.

Qualifications

• 4–10 years in medical device quality or engineering required.
• Experience with complaint investigations preferred.
• Must have strong knowledge of CAPA and ISO 14971.

Responsibilities

• Investigate product complaints and manage returns.
• Support new product development ensuring regulatory compliance.
• Collaborate with engineering teams on product design reviews.

Skills

Complaint investigation

Root cause analysis

Regulatory compliance

Statistical techniques

Project management

Education

Bachelor’s in Engineering or Natural Science

Tools

MS Office

SolidWorks

Job description

Notice: MCRA’s Talent Solutions division works to untie top talent with opportunities on our clients’ teams. This posting is not for a position directly at MCRA, but rather for a position with a MCRA client that our team is helping to recruit and fill.

Summary

Responsible for ensuring product quality and safety for both new product development and existing products. Applies engineering and statistical techniques to support design, manufacturing, and post-market activities. Manages multiple projects and collaborates across teams to meet quality objectives and regulatory requirements.

Duties and Responsibilities

Quality Engineering – Post Market & Manufacturing Support

• Investigate product complaints, manage returns, and perform root cause analysis.
• Track and report post-market data and update risk management files.
• Execute CAPA investigations and corrective actions.
• Maintain supplier quality through evaluations and audits.
• Ensure compliance with FDA, ISO 13485, MDD, and MDR standards.
• Support manufacturing changes, non-conformance reports, and device history reviews.
• Maintain sterilization validations and microbiological control programs.

Quality Engineering – New Product Development

• Serve as Quality representative on development teams.
• Ensure new products meet regulatory and quality standards.
• Develop inspection and quality plans; provide statistical guidance.
• Collaborate with Engineering on design reviews, verification/validation testing, and risk management (FMEAs).
• Support process capability, equipment qualification, and validation activities.

Quality Systems

• Support complaint processing, recalls, supplier quality, CAPA, audits, and management reviews.
• Assist with regulatory inspections and EU MDR transition.

Education & Experience

• Bachelor’s in Engineering (preferred) or Natural Science.
• 4–10 years in medical device quality or engineering (or 2 years with advanced degree).
• Complaint investigation experience preferred.
• Strong knowledge of validation, root cause analysis, CAPA, and ISO 14971.
• Adaptable, organized, and effective in fast-paced environments.
• Proficient in MS Office; SolidWorks preferred.

Special Requirements

• Onsite