To support the implementation and maintenance of facility level quality systems which are in full compliance with corporate policies and procedures, government regulations, and international standards. To support the design implementation of new products and related manufacturing processes.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
•Assist Q.A. Manager in the development, documentation, implementation, and maintenance of quality system procedures, instructions, and records.
•Can perform routine internal quality system audits, supplier audits and supplier qualifications in compliance with procedures. Reports audit findings to management.
•May lead or participate with organizational and group operations’ management in CAPA activities by conducting, determining and verifying corrective actions necessary to ensure continued compliance with division policy and procedures, Federal regulations under Title 21 CFR Part 820, and ISO 13485:2016.
•Assists departmental management and personnel in the implementation of statistical quality control techniques for the purpose of improving operational efficiency and effectiveness.
•Works with the appropriate department management to initiate corrective action necessary to resolve quality related problems identified as a result of the routine analysis of product performance data.
•Participates in CPE projects, and product and process validation and verification according to quality system procedures.
•Responsible for monitoring, identifying tendencies, investigating and solving problems submitted through customer complaints.
•Works with suppliers to improve component quality.
•Can lead or participate in project transfers and process controls, establishing acceptance criteria of the product, quality and calibration.
•Establish Incoming Inspection plans, component qualification, sampling plans, and component criteria.
•Lead or participate in Value Stream projects (quality improvements, cost savings, increase of productivity).
B.S. Degree in Engineering or technical discipline.
Five years of experience in manufacturing operation.
Formal education or training in quality assurance techniques including quality system auditing, statistical tools, design of experiments, regression analysis, and statistical sampling methods, Lean principles.
Experience desirable in medical device regulations and standards, including FDA’s medical device regulations covered under Title 21 CFR Part 820, European Medical Device Directive 93/42/EEC are preferred.
Bilingual: Oral and written communications in English and Spanish required.
|Área||Control de Calidad|
|Horario||7:00 - 17:00 hrs|