Quality Management Specialist - Compunnel : Job Details

Job Description:

This position is to assist with a major project in Oneonta with changes to the documentation system and preparing for an audit.

Experience/skills needed:

• Associates or Bachelor's Degree, 3+ years of work equivalent experience (work in a manufacturing environment is preferred).
• Previous experience using ETQ or other Document Management software preferred.
• Proficiency in Microsoft office.
• Experience in ISO 9001 or other Quality System standards.
• ISO 13485 and 21 CFR 820 Quality Management Systems knowledge highly preferred.

Summary:

• 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.
• Other duties as required.

Minimum Qualifications:

• Associates or Bachelor's Degree, 3+ years of work equivalent experience (work in a manufacturing environment is preferred).

Skills/Experience:

• Previous experience using ETQ or other Document Management software preferred.
• Proficiency in Microsoft office.
• Experience in ISO 9001 or other Quality System standards.
• ISO 13485 and 21 CFR 820 Quality Management Systems knowledge highly preferred.
• Internal auditor experience and/or training.
• Must be detail oriented and accurate in execution of work.
• 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.