QA Specialist II - Intellectt : Job Details

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Hello,

One of my clients is currently seeking a QA Specialist II. If this role aligns with your experience or interests, I'd love to connect with you. Please share your updated resume with me at [email protected], or feel free to call me directly at (732) ###-#### to discuss further.

Job Title: QA Specialist II

Location: Alameda, CA

Duration: 12 Months

Shift: Monday – Friday, 8:00 AM – 5:00 PM

Interview Process:

• Initial Phone Screening with Hiring Manager
• Second Round Onsite Interview with Hiring Manager & Team

Position Overview:

We are seeking a skilled QA Specialist II with deep experience in customer complaint handling within a manufacturing QA environment. This role is critical in ensuring the integrity of the post-market quality system by assessing complaints and supporting regulatory compliance across global markets.

Key Responsibilities:

• Serve as a subject matter expert in complaint handling processes.
• Perform complaint evaluation, pre-assessment, and closure in accordance with internal procedures and regulatory requirements (FDA, ISO, OUS standards).
• Conduct reportability assessments for global markets.
• Participate in CAPA investigations and deviation management.
• Contribute to redlining and creating complaint-handling procedures, managing a large library (250+ procedures).
• Ensure Good Documentation Practices (GDP) and maintain complaint records aligned with compliance standards.
• Collaborate cross-functionally with Quality, Regulatory, and Manufacturing teams.
• Support post-market surveillance activities through analysis and trending.

Required Qualifications:

• 3–7 years of hands-on experience in complaint handling within a regulated industry.
• Strong understanding of quality systems, complaint evaluation, and documentation practices.
• Experience in redlining procedures, creating or revising complaint-related SOPs.
• Familiarity with ISO and OUS regulatory standards.
• Experience working with CAPAs and deviation records.
• Ability to work cross-functionally and communicate effectively.

Preferred Qualifications:

• Experience with post-market surveillance in the medical device or life sciences industry.
• Exposure to manufacturing QA processes.
• Background in medical devices (preferred but not required).

Education:

• Associate Degree is acceptable; Bachelor's Degree is a plus but not required.
• Education is secondary to relevant experience.

Seniority level

• Seniority levelMid-Senior level

Employment type

• Employment typeContract

Job function

• Job functionQuality Assurance
• IndustriesMedical Practices and Medical Equipment Manufacturing

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