Quality Specialist

Net2Source Inc.; Salt Lake City (UT); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading company in medical equipment manufacturing is seeking a Specialist I in Quality Systems for a 12-month contract position. The successful candidate will coordinate document control activities, participate in audits, and ensure compliance with cGMP and FDA guidelines. Ideal candidates will have a Bachelor's Degree or significant experience in quality assurance, strong communication skills, and the ability to manage multiple tasks effectively.

Qualifications

• Ability to complete projects assigned by senior members.
• Familiarity with cGMP and FDA standards is crucial.
• Experience in documentation writing is preferred.

Responsibilities

• Coordinate and manage document change requests.
• Support regulatory audits and inspections.
• Participate in process improvement efforts.

Skills

Strong verbal and written communication skills

Excellent organizational skills

Knowledge of cGMP, FDA guidelines

Ability to learn industry best practices

Education

Bachelor's Degree from an accredited college or university

AAS with 10 years of experience in regulatory quality

Tools

Oracle

SQL

Power query

Visual Basic

Job description

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Duration: 12 months contract(Extendable)

Pay Rate: $21.37 per hour on W2.

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.

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• Assure accurate and orderly file maintenance of current and historical documents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

• 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

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Contract

Job function

• Job function

  Other

• Industries

  Medical Equipment Manufacturing

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