Generates, reviews, and maintains division level quality system documents including procedures, work instructions, job aids, certificate of conformances, etc. in compliance with ISO 13485, ISO 9001, and 21 CFR 820 standards.
Initiates Change Controls and Document Change Requests to update procedures and processes.
Collaborates with manufacturing and distribution sites to assess the impact of changes to site level processes.
Assists with monitoring and assessing quality system metrics to ensure maintained compliance.
Acts as a lead auditor for division internal audit program.
Assists with completing quality projects and uses root cause analysis to assist in the completion of CAPAs.
Supports or leads continuous improvement initiatives for quality management system processes.
Assists with regulatory activities.
Requirements:
Bachelor's Degree, 3+ years of work equivalent experience (work in a manufacturing environment is preferred).
Master's Degree, 1+ years of work equivalent experience (work in a manufacturing environment is preferred).
Proficiency in Microsoft office.
ISO 13485 and 21 CFR 820 Quality Management Systems knowledge.
Internal auditor experience and/or training.
Must be detail oriented and accurate.
Ability to apply basic mathematical concepts such as percentages, ratios, and proportions to practical situations.
Ability to work across matrix organizations and external consultants.
Able to take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary.
How strong is your resume?
Upload your resume and get feedback from our expert to help land this job
How strong is your resume?
Upload your resume and get feedback from our expert to help land this job