What are the responsibilities and job description for the QA Specialist (Medical Devices position at TekOne IT Services Pvt. Ltd.?
Title: QA Specialist (Medical Devices)
Location: Abbott Park, IL - 60064-3500
Duration: 7 Months
Shift Timings: 8 AM to 4:30 PM
Core Job Responsibilities
Responsible for implementing and maintaining the effectiveness of the quality system.
Bachelor’s or master’s degree (or equivalent) in a science or closely related discipline and 2-3
years’ experience.
Location: Abbott Park, IL - 60064-3500
Duration: 7 Months
Shift Timings: 8 AM to 4:30 PM
Core Job Responsibilities
Responsible for implementing and maintaining the effectiveness of the quality system.
- CAPA - Investigates standard testing out of tolerance and out of specification (OOS) results including complaints. Supports ticket trending process and maintains quality records. Takes ownership and approves any OOS, invalid, and/or aberrant results. May write protocols for investigations.
- Communications - Communicate and collaborate effectively within the team and management.
- Documentation - Maintain relevant documents and records.
- Basic Requirements – Performs quality testing in a high-paced laboratory environment. Has multiple certifications and is cross trained in other types of assays.
- Manage Product and Process Improvements
- Participate in project and process improvement activities. Monitor performance of testing processes and implement required improvement activities.
- Suggests to manager and implements process improvements within own work area that fosters a culture of continuous improvement. Supports work area processes and product development/improvement projects.
- Provide quality support to key processes and product development/improvement projects. Takes a lead in the lab to ensure Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs) are executed and the lab is running efficiently.
- Management of Computer Systems - Maintain and update relevant computer applications. Become an SME on the computer systems.
- Quality/Compliance -Support manufacturing and testing operations as required; adhering to GMPs and GLPs. Possess a more involved understanding of the Quality System; including the subsystems and is familiar with the Quality System Key processes. Keep abreast of the standards that regulate our industry.
- Participate and take all trainings and reviews as required on the Electronic Training Management System
- ETMS. Conduct business in a manner that will protect human health; safety and the environment by complying with all applicable EHS laws; as well at the Abbott Global and Technical standards. Comply with Abbott Quality System (QS) requirements.
- Share Quality Knowledge - Shares quality knowledge; liaising with colleagues within team.
- Training - Undertake all trainings and reviews as required on the Electronic Training Management System - ETMS.
- Testing: Platform lab (Alinity s and/or ARCHITECT) and/or Biochemistry/Chemistry
- Complete quality testing as appropriate per product procedures and review all data to determine conformance with specifications.
- Provide information for tracking and trending of data as required. Take appropriate action per procedural requirements and schedule when test results specifications are not met.
- Redline documents and provide adequate feedback.
- Sample & File Storage - Ensure storage of samples and documents in the appropriate filling systems.
- Lab Safety – Participates in lab safety
- Individuals execute daily testing in a high-paced laboratory environment. Identify and escalate any potential non-conformances / issues to quality professionals. Work closely with product technical support.
- Perform activities as assigned by quality professionals / manager. Apply appropriate actions to resolve with support from quality professionals. Support relevant activities. Help with any data pulls or document red lines/updates. Become an SME on lab certifications. Leader within the lab. May also lead lab projects and be called on to attend meetings. Advanced computer skills (Word, Excel) are a must.
Bachelor’s or master’s degree (or equivalent) in a science or closely related discipline and 2-3
years’ experience.
