Change Control Quality Specialist - Medical Device

Job Title: Quality Specialist

Location: Salt Lake City, UT 84123

100% onsite

Duration: 12+ Months contract

Pay Rate: $25.00-$28.95/hour on W2

Job Description:

Position Summary

The Specialist I, Quality Systems will support functional activities associated with electronic document and record control, including periodic review, retention, storage, and change control. This position will coordinate, manage, initiate and route document change requests. This position will also be responsible for reviews and formatting of draft documents, procedures, and records using the change control system.

Essential Duties & Responsibilities

• Evaluate Change Orders acting as Change Analyst based on Procedure Requirements and Standards related to Change Control

• Track and provide product documentation status reports and analyze data from QMS processes.

• Perform various types of documentation information queries through computerized systems

• Assure accurate and orderly file maintenance of current and historical documents

• Provide back up for specification control and batch record maintenance activities

• Perform or support periodic documentation audits (planned or unplanned)

• Participate in process improvement efforts

• Review and revise departmental operating procedures as required

• Participate in meetings and activities to support new product introduction or conversions

• Support site with creation of learning content

• Provide troubleshooting and training support for employees about Change Control requirements for Quality Procedures, Work Instructions, Parts and Specification.

• Maintain paper records per record retention procedures and standards

• Support Regulatory Audits and Inspections as needed.

• Work on special assignments as they arise

Knowledge, Skills & Qualifications

• Ability to complete basic projects assigned by senior team members and managers

• Ability to learn the function and industry best practices

• Working knowledge of all functions of Distributed Documentation preferred

• Product component knowledge preferred

• Understanding of structure and role of product specifications

• Ability to become knowledgeable in departmental procedures, GMP's, Specifications/Guidelines, product lines/processes and commodities

• Familiarity with cGMP, FDA, and guidelines governing medical devices.

• Strong verbal and written communication skills

• Excellent organizational skills

• Knowledge of Oracle, SQL, Power query, Visual Basic

• Experience in documentation writing, to create clear/concise written materials to help users understand a product, process, or subject.

Education and Experience

• Bachelor's Degree from an accredited college or university (business, teaching, science/biology)

OR

• AAS with 10 years of experience, preferably in a regulatory, quality or compliance position

Minimum Qualifications

• Must be 18 years of age

Travel Requirements

• Typically requires travel less than 5% of the time

Physical Requirements and Work Environment

• This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers and filing cabinets.

• While performing the duties of this job, the employee may be required to sit or stand for long periods of time.

• Must be able to occasionally move and lift objects of up to 25 pounds.