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Baxter Healthcare - Welch Allyn De Mexico, S. De R.L. De C.V. is seeking a highly skilled Senior Quality Assurance Specialist to join our team. As a key member of our quality assurance department, you will be responsible for ensuring compliance with quality objectives and regulatory requirements.
Key Responsibilities- Lead and participate in NCR, SNCR, CAPA activities in accordance with established procedures.
- Oversee validation activities, including IQs, TMVs, OQs, and PQs, for designated areas.
- Assist management and departmental staff in implementing statistical quality control techniques to improve operational efficiency and effectiveness.
- Analyze data obtained from the field to investigate and resolve issues identified through Post Market Surveillance Reports.
- Participate in project transfers, identifying and closing gaps in the quality system and manufacturing processes.
- Support the implementation of quality controls and project deadlines.
- Contribute to Value Stream projects focused on quality improvements, cost savings, and productivity gains.
- Validation experience (IQ, TMVs, OQ, PQ)
- Formal education or training in quality control techniques, including quality system audits, statistical tools, design of experiments, statistical sampling methods, and testing methods.
- Desired knowledge in medical device regulations and standards, including FDA medical device regulations (21 CFR Part 820) and European Medical Device Directive (93/42/EEC / EU MDR).
- Baxter Healthcare - Welch Allyn De Mexico, S. De R.L. De C.V.
- Job Type: Permanent
- Work Mode: On-site
- Shift: Day shift
- Work Schedule: Full-time
- Education: Bachelor's degree
- Sex: Non-discriminatory
- Travel Availability: Yes
