Spec, Quality

Responsibilities:

1. Leads or participates in NCR, SNCR, CAPA activities in accordance with established procedures and ensures compliance with quality objectives.
2. Leads/oversees validation activities, IQs, TMVs, OQs, PQs, for designated areas.
3. Assists management and departmental staff in the implementation of statistical quality control techniques in order to improve operational efficiency and effectiveness.
4. Responsible for the analysis of data obtained from the field to investigate and resolve issues identified through Post Market Surveillance Report.
5. Participates or leads project transfer, through the identification and closing of gaps from the quality system and manufacturing processes, establishing product acceptance criteria, ensuring quality controls and supporting project deadlines.
6. Participates in Value Stream projects (quality improvements, cost savings, productivity gains).

Minimum Requirements:

1. Validation Experience (IQ, TMVs, OQ, PQ).
2. Formal education or training in quality control techniques, including quality system audits, statistical tools, design of experiments, statistical sampling methods and testing methods, Lean principles, etc.
3. Desired Knowledge in medical device regulations and standards, including FDA medical device regulations covered by Title 21 CFR Part 820, European Medical Device Directive 93/42/EEC / EU MDR.