Position: Quality Engineer II , Req#: CRNGJP00027740

Location: Oneonta, NY (100% Onsite)

Duration: 9+ Months Contract

Interview Process: Phone screen and then an onsite interview

M-F, 8 am - 5 pm

Job Description:

This position is to assist with a major project in Oneonta with changes to the documentation system and preparing for an audit. 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, and regulatory activities and supports quality management system projects and tasks.

Education and Experience:

• Associate 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

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 the 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.

Job Responsibilities:

• 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 the division's 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.