What are the responsibilities and job description for the Quality Engineer position at 9992?
This position is responsible for performing change controls, creating and updating quality management procedures, managing records, and performing internal audits in compliance with the Quality Management System. Assists with the analysis of data for quality management system metrics, regulatory activities and supports quality management system projects and tasks.
Description of Work:
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.
Minimum Qualifications:
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).
Skills/Experience:
Previous experience using ETQ software 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.
Salary : $45 - $47