What are the responsibilities and job description for the Quality Management Systems Specialist position at DivIHN Integration Inc?

DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.

Visit us at

https : / / divihn.com / find-a-job /

to learn more and view our open positions.

Please apply or call one of us to learn more

For further information please contact one of our Talent Specialists :

Meghna at

224 369 4230

Infant at

224 507 1261

Title : Quality Management Systems Specialist

Location : Oneonta, NY

Duration : 9 Months

Working Hours : M-F, 8am - 5pm

Description

Interview Process : Phone screen and then onsite interview
Position could be extended, but that won't be determined until closer to November.
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.

About us :

DivIHN , the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.

Apply for this job

Receive alerts for other Quality Management Systems Specialist job openings

Quality Management Systems Specialist

What are the responsibilities and job description for the Quality Management Systems Specialist position at DivIHN Integration Inc?

What is the career path for a Quality Management Systems Specialist?

Job openings at DivIHN Integration Inc

Not the job you're looking for? Here are some other Quality Management Systems Specialist jobs in the Oneonta, NY area that may be a better fit.

We don't have any other Quality Management Systems Specialist jobs in the Oneonta, NY area right now.

AI Assistant is available now!