QA Specialist (Post-Market Surveillance)

Job Title: QA Specialist (Post-Market Surveillance)

Location: Arden Hills, MN (4 days onsite / 1 day remote per week)

Employment Type: W2 Contract

Duration: 12 months, with potential extensions

Salary/Rate: $30–$35 per hour on W2

This is a good-faith estimate of the anticipated pay range for this position. Actual compensation may vary based on relevant experience, qualifications, skills, and other job-related factors, consistent with applicable law.

Benefits: No employer-provided benefits.

About the Role:

Our client, a leader in the medical device industry, is seeking a QA Specialist to join their Post-Market Surveillance team in Arden Hills, MN. This role is responsible for analyzing complaint and adverse event data, leading root cause investigations on escalated product signals, and driving continuous improvement across quality processes. The ideal candidate has strong hands-on investigative experience and is comfortable presenting findings to leadership and cross-functional design teams.

Key Responsibilities:

• Analyze post-market surveillance data (complaints, adverse events) to drive timely investigation and resolution of safety and quality issues
• Lead root cause investigations on escalated product signals and document findings within the quality system
• Own Non-Conforming Event Reports (NCEPs) and CAPAs directly, as assigned
• Present product performance insights to leadership and design teams; support published performance reports
• Mentor product investigators and promote effective utilization of investigative equipment such as X-Ray, FTIR, and SEM
• Champion continuous improvement initiatives across local and global Post Market teams

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or related technical field
• Prior experience in a medical device or regulated manufacturing environment
• Hands-on experience with root cause investigation methodologies (e.g., 5 Why, Fishbone, FMEA)
• Experience with CAPA and NCEP documentation within a quality management system
• Familiarity with investigative/failure analysis equipment (X-Ray, FTIR, SEM) preferred
• Working knowledge of 21 CFR 820, ISO 13485, and post-market surveillance requirements
• Strong written and verbal communication skills, with experience presenting to leadership
• Ability to work onsite in Arden Hills, MN 4 days per week

Work Requirements:

• Ability to work onsite in Arden Hills, MN, 4 days per week, with 1 remote workday per week.
• Must be available to work the agreed-upon W2 contract schedule.
• Must provide 2 professional manager references from prior employment.
• Ability to work effectively with local and global Post Market, Quality, Engineering, and Design teams.
• Work must be performed in accordance with applicable company quality procedures, regulatory requirements, and workplace policies.

Equal Opportunity Employer:

Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made based on job-related qualifications, merit, and business needs, consistent with applicable federal, state, and local laws. We do not discriminate on the basis of any legally protected characteristic.

Application:

Qualified candidates may submit their resume and relevant professional experience for consideration. Please include contact information for two professional manager references when requested during the hiring process.