QA Specialist II (Medical Device) - Intellectt INC

Role:QA Specialist II (Medical Device)
Location: Austin, TX - 78759 (Onsite)
Duration: 13 Months (Possible extensions) on W2
Shift Timings: 8:00 AM to 6:00 PM, Wednesday through Saturday

Job Description:

The QA Specialist II is responsible for assuring the quality of manufactured products and processes in accordance with Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMPs). The position will be primarily focused on batch record review and quality documentation approvals in support of medical device production.

Responsibilities:

• Perform batch reviews and manage quality documentation approvals.
• Review device history records and handle documentation for third-party medical devices.
• Ensure compliance with procedures and escalate issues when necessary.
• Work closely with cross-functional teams to maintain product and process quality.
• Support CAPA (Corrective and Preventive Action) processes and address nonconformance reports when applicable.

Qualifications:

• Education: Bachelor's degree in STEM (Science, Technology, Engineering, Mathematics) preferred.
• Experience: Minimum 3 years of experience in a regulated medical device or pharmaceutical environment, preferably in manufacturing.
  (Internships, co-ops, and schooling will not be considered. Master's degrees will not replace the required experience.)
• Strong experience with documentation (batch reviews, quality document approvals, lab notebooks related to design, manufacturing, or release).