Top 23 Comrise Jobs | SimplyHired

Senior Quality Systems Specialist
Comrise —Cary, IL
- $50 - $55 an hour
- Contract
- Hybrid work
- Microsoft Excel
- Engineering
- Mentoring
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10d
HRBP (Bilingual English and Mandarin/Spanish) - 28020 - CJ
Comrise, Inc. —San Jose, CA
- $85,000 - $95,000 a year
- Full-time
- Background check
- Spanish
- 5 years
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Autonomous Vehicle Systems Technician
Comrise —San Francisco, CA
- $35 - $50 an hour
- Schematics
- Mid-level
- High school diploma or GED
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12d
HR Generalist (Biopharma/Biotech)
Comrise —Princeton, NJ
- $85,000 - $95,000 a year
- 5 years
- Mid-level
- Bachelor's degree
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Regional Manager - 28098 - SX
Comrise —Albany, NY
- Up to $60,000 a year
- Full-time
- Background check
- Customer service
- Mid-level
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5d
Talent Acquisition Specialist (Bilingual English and Mandarin/Spanish) - 28021 - SX
Comrise, Inc. —San Jose, CA
- $85,000 - $95,000 a year
- Full-time
- Background check
- Spanish
- Office
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Construction Site Project Manager (Bilingual Mandarin) - 28031 - CJ
Comrise —New York, NY
- $90,000 - $100,000 a year
- Full-time
- Background check
- Construction site
- Mid-level
- Opportunities for advancement
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7d
Bilingual Mandarin Fleet Support Supervisor - 28097 - SP
Comrise —Carteret, NJ
- $70,000 - $80,000 a year
- Full-time
- Background check
- English
- Mid-level
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5d
Setup Machinist (CNC) - 28066 - SP
Comrise —West Chester, PA
- $27 - $35 an hour
- Full-time
- Background check
- Mid-level
- 3 years
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11d
Operations Manager - Beverage (Bilingual Mandarin) - 28010 - CJ
Comrise, Inc. —San Gabriel, CA
- $90,000 - $100,000 a year
- Full-time
- Background check
- 5 years
- Merchandising
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Operations Manager - Sushi (Bilingual Mandarin) - 28010 - SX
Comrise, Inc. —San Gabriel, CA
- $90,000 - $100,000 a year
- Full-time
- Background check
- 5 years
- Merchandising
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HRBP (Bilingual English and Mandarin/Spanish) - 28020 - CJ
Comrise, Inc. —San Jose, CA
*Compliance:* Ensure adherence to federal, California state, and local employment laws (e.g., wage and hour, meal/rest breaks, leave requirements).
$85,000 - $95,000 a year
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Senior Quality Systems Specialist

Comrise -
Cary, IL

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Job Details

Contract
$50 - $55 an hour
10 days ago

Qualifications

Project team coordination
Microsoft Excel
Content creation for technical audiences
Coaching
Regulatory compliance
Change management
Mentoring
Microsoft Teams
SharePoint
Biomedical regulatory compliance
Productivity software
International corporation experience
Technical writing experience within technology
Technical Proficiency
Cross-functional communication
FDA regulations

Full Job Description

QMS, Change Control, Medical Device, and Integration Project
Location: Cary, IL
Schedule: Hybrid (3 days onsite / 2 days remote)
Duration: 18-Month Contract
Hours: Monday Friday, 8:00 AM 5:00 PM (flexibility required to collaborate with international teams)

Pay range: $50-$55/hour

We are seeking a highly motivated Staff Quality Systems Specialist (Contractor) to support QMS integration activities by leading and owning the Change Control process within a regulated medical device environment.

In this role, you will ensure that all changes are appropriately documented, assessed for impact, and effectively implemented in alignment with quality and regulatory requirements. You will also mentor cross-functional stakeholders on proper change execution and support the integration of quality system processes across the organization.

This position is ideal for a detail-oriented professional with strong technical writing skills and a deep understanding of how quality system processes interact (e.g., change control, document control, training, and records management).
This role requires close collaboration with teams in Germany and flexibility to align with CET/CEST working hours.

Own and manage the Change Control process to ensure compliance, consistency, and effectiveness
Review and approve change records for completeness, accuracy, and appropriate impact assessments
Ensure changes are implemented appropriately, including verification of downstream activities (e.g., documentation updates, training completion, record retention)
Drive process improvements and standardization to support integration efforts
Evaluate process gaps and define compliant, scalable solutions
Collaborate with cross-functional teams to align change activities with integration timelines and business needs
Mentor and guide change owners and stakeholders on proper change control processes
Provide coaching on impact assessment, documentation expectations, and process requirements
Promote consistent and high-quality execution of change activities across the organization
Develop and revise quality system documentation, including procedures, work instructions, and change records
Ensure documentation is clear, accurate, and compliant with internal and regulatory requirements
Partner with Quality, Regulatory, R&D, and Operations teams to ensure alignment on changes and integration efforts
Act as a quality representative in project discussions and integration activities
Communicate progress, risks, and recommendations to key stakeholders

Qualifications:

Bachelor's degree in engineering, science, or a related field
5+ years of experience in a regulated environment (medical device preferred)
Proven experience with Change Control processes and quality system integration or harmonization
Experience supporting integration of products, systems, or acquired businesses is strongly preferred

Required:

Strong knowledge of Quality Management Systems (QMS) and applicable regulatory requirements (e.g., FDA, ISO 13485, EU MDR)
Deep understanding of interactions between Change Control, Document Control, Training, and Records processes
Excellent technical writing and documentation skills
Strong organizational, problem-solving, and project coordination abilities
Ability to influence, mentor, and drive consistent process execution across cross-functional teams
Ability to manage multiple priorities in a fast-paced, integration-focused environment
Strong attention to detail and commitment to quality and compliance
Collaborative mindset with a proactive, solution-oriented approach
Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, Teams, and SharePoint
Business-level fluency in English (written and verbal)
Ability to work flexible hours to accommodate German time zones

Preferred:

Experience supporting QMS integration in a global environment
German language proficiency (written and verbal)

#ESJ

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Refine Your Search

Comrise jobs

Senior Quality Systems Specialist

HRBP (Bilingual English and Mandarin/Spanish) - 28020 - CJ

Autonomous Vehicle Systems Technician

HR Generalist (Biopharma/Biotech)

Regional Manager - 28098 - SX

Talent Acquisition Specialist (Bilingual English and Mandarin/Spanish) - 28021 - SX

Construction Site Project Manager (Bilingual Mandarin) - 28031 - CJ

Bilingual Mandarin Fleet Support Supervisor - 28097 - SP

Setup Machinist (CNC) - 28066 - SP

Operations Manager - Beverage (Bilingual Mandarin) - 28010 - CJ

Operations Manager - Sushi (Bilingual Mandarin) - 28010 - SX

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