Senior Quality Assurance Analyst

X4 Life Sciences; New Jersey; Hybrid; USD 70,000 - 100,000; Full time

Job summary

A leading medical device company is seeking a Senior Complaints Analyst to join their Regulatory Affairs team in New Jersey. This hybrid contract-to-perm role focuses on post-market activities, including complaint handling and regulatory compliance, offering the chance to contribute to impactful healthcare products.

Qualifications

• 3+ years of experience in the medical device industry.
• Strong knowledge of 21 CFR Part 820 and ISO 13485.
• Detail-oriented with a collaborative mindset.

Responsibilities

• Investigate and process product complaints and Medical Device Reports (MDRs).
• Support root cause investigations with quality and engineering teams.
• Assist with regulatory tasks such as recalls and documentation.

Skills

Attention to detail

Proactiveness

Education

Bachelor’s degree or equivalent experience

Job description

Direct message the job poster from X4 Life Sciences

Empowering Digital Health & Medical Device Organizations Across the US | Engineering (Software, Mechanical) Quality Assurance, Regulatory Affairs.

Senior Complaints Analyst / RA Associate

Medical Devices | Contract-to-Perm | New Jersey (Hybrid)

We’re working with a leading medical device company seeking an experienced Senior Complaints Analyst to join their Regulatory Affairs team. This is a contract-to-perm opportunity with a hybrid working model, offering the chance to contribute to products that directly impact patient care.

This role sits within the Regulatory Affairs team and focuses heavily on post-market activities, particularly complaint handling, with additional exposure to MDR submissions, recall coordination, audit support, and broader regulatory responsibilities across the U.S. and Canada.

Key Responsibilities:

• Investigate and process product complaints and associated Medical Device Reports (MDRs)
• Source and analyze technical and historical quality data
• Support root cause investigations in collaboration with quality, engineering, and clinical teams
• Assist with regulatory tasks such as recalls, state licensing, and documentation
• Continuously contribute ideas to improve processes and maintain compliance

What We’re Looking For:

• 3+ years of experience in the medical device industry
• Strong knowledge of 21 CFR Part 820 and ISO 13485, particularly around complaint handling
• Highly detail-oriented with a collaborative, proactive mindset
• Bachelor’s degree or equivalent experience.

If this sounds like the right fit, or you know someone who could be a match, please reach out or send your CV to [e-mail].

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance and Analyst

• Industries

  Medical Equipment Manufacturing and Staffing and Recruiting

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