Quality Assurance Remediation Consultant (Medtech)

TL;DR

Quality Assurance Remediation Consultant (Medtech): Managing a backlog of 400 investigations and 70-100 CAPAs for a medical device client with an accent on aseptic and contamination control processes. Focus on executing remediation strategies and ensuring compliance within a large-scale QA team environment.

Location: Must be onsite in Hunt Valley, MD for the duration of the 6-18 month engagement.

Company

hirify.global provides expert consulting services across the product lifecycle for biotech, medical device, and pharmaceutical organizations.

What you will do

• Address a backlog of 400 investigations and 70-100 CAPAs.
• Apply aseptic and contamination control expertise to remediation efforts.
• Collaborate within a large QA team of 100 personnel.
• Ensure adherence to regulatory standards and compliance requirements.
• Execute remediation tasks to support high-profile medical device programs.

Requirements

• Must be able to work onsite in Hunt Valley, MD for the full duration of the engagement.
• Proven experience in quality assurance remediation.
• Strong background in investigations and CAPA management.
• Expertise in aseptic and contamination control.
• Ability to commit to a 6-18 month project timeline.

Culture & Benefits

• Commitment to diversity, equity, and inclusion.
• Supportive environment that encourages innovative and entrepreneurial spirit.
• Opportunity to work on high-profile drug and device programs.
• Holistic approach as an Equal Opportunity Employer.