Our client, a Global Medical Device Manufacture has an immediate opening for a Post Market Quality Engineer for a 12 Month Contract opportunity. Our client offers results-driven people a place where they can make a difference - every day!  You will also have the opportunity to work with other like-minded, self-directed and detail-oriented Top Talents in an extremely collaborative and professional environment.  

Position Description

This Sr. Quality Engineer role will join our clients integration team. This role will support post-market surveillance, complaint handling, and continuous improvement activities while ensuring compliance with regulatory requirements. As part of a recent acquisition of a software technology company, this individual will support activities to integrate this new business with an existing medical device quality system. Experience with software products and non-medical devices is preferred to assist in the post-market assessment activities and quality system integration.  

MAJOR DUTIES/RESPONSIBILITIES:

• Complaint Management and Issue Resolution:
  • Manage and analyze customer complaints, warranty claims, and field failures to identify root causes, drive effective corrective actions, and improve product reliability.
  • Support the development and assessment of product return process as part of complaint handling.
  • Collaborate with cross-functional teams to ensure timely closure and documentation of complaints.
  • Develop and deliver regular trend analyses and reports to identify systemic issues and areas for improvement.
• Quality System Management:
  • Support the maintenance and continuous improvement of the Quality Management System (QMS) in alignment with industry standards (e.g., ISO 9001, ISO 27001, TL 9000).
  • Create, review, and update quality procedures, work instructions, and best practices.
  • Consult with various Post Market stakeholders to create and propose process maps that may be used as part of procedure creation.

REQUIREMENTS

• Bachelor's degree in Engineering, Life Sciences, or related field (or equivalent experience). 
• 3+ years of experience in Quality Engineering within the medical device, pharmaceutical, or related regulated industry. 
• Strong knowledge of quality system regulations (ISO 13485, 21 CFR Part 820) 
• Experience with complaint handling, CAPA, and nonconformance management. 
• Excellent problem-solving, data analysis, and communication skills.