134 applicantsPosted by Agency

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Company

Compunnel Inc. · 1 day ago

Quality Management Systems Specialist

United States

Contract

Remote

Mid Level

$45/hr - $50/hr

3+ years exp

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Information Technology & Services

Growth Opportunities

H1B Sponsor Likely

Hiring Manager

Chirag Soni

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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 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.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

ISO 1348521 CFR 820ETQ softwareInternal auditingMicrosoft OfficeMathematical conceptsOwnership of assignmentsCross-functional collaboration

Required

Bachelor’s Degree, 3+ years of work equivalent experience (work in a manufacturing environment is preferred)

Master’s Degree, 1+ years of work equivalent experience (work in a manufacturing environment is preferred)

Proficiency in Microsoft office

ISO 13485 and 21 CFR 820 Quality Management Systems knowledge

Internal auditor experience and/or training

Must be detail oriented and accurate

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

Preferred

Previous experience using ETQ software

Company

Compunnel Inc.

Glassdoor

4.2

Compunnel, Inc., founded in 1994 and headquartered in New Jersey, is at the forefront of providing customized workforce and digital transformation solutions, enhancing the total experience for our valued business allies.

Founded in 1994

Plainsboro, New Jersey, US

5001-10000 employees

http://www.compunnel.com

H1B Sponsorship

Compunnel Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2023 (1572)

2022 (2192)

2021 (2385)

2020 (2157)