Quality Assurance Specialist


Quality Assurance Specialist - Top rated Medical Products and Devices Company



JOB OVERVIEW:

This position is responsible for executing Quality Management System processes and conducting quality assurance audits of the quality management system to ensure compliance with ISO 13485:2016 standard and applicable regulatory requirements.

KEY RESPONSIBILITIES:


Conduct Quality Assurance audits of suppliers of Medical Devices products and services and for the issuance of reports to management.
Conduct Internal Quality Assurance Audits as scheduled and ensure the effective and timely facilitation of suppliers and internal quality audits and follow-up on CAPAs/Observations.
Research applicable FDA, ISO and ASTM standards to ensure the company’s ongoing compliance with U.S. Regulatory Requirements
Provide assistance to Quality Auditors with the most up-to-date regulations, and quality tools.
Review and revise then execute Quality Agreements with suppliers in accordance with ISO, cGMP and 21 CFR regulations.
Author and, review standard operating procedures through Power DMS, cloud based document control system.
Support the Corrective Action and Preventive Action process and the Non-Conforming Material process.
Participate in special projects and perform other duties as required.



Qualifications:


MINIMUM WORK EXPERIENCE:
Typically 2 to 4 years of related professional experience.

PREFERRED EDUCATION:
Typically a Bachelor's Degree or global equivalent in related discipline




GENERAL SKILLS & COMPETENCIES:


Basic understanding of industry practices
General proficiency with tools, systems, and procedures
Basic planning/organizational skills and techniques
Good decision making, analysis and problem solving skills
Good verbal and written communication skills
Basic presentation and public speaking skills
Basic interpersonal skills
Developing professional credibility


SPECIFIC KNOWLEDGE & SKILLS:

General knowledge of ISO 9001 and 13485 certification and maintenance.
21 CFR 820 regulations.


TRAVEL / PHYSICAL DEMANDS:

Travel typically less than 35%. Office environment. No special physical demands required.

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Reference number US_EN_2_022924_141048