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Device History Record Jobs (NOW HIRING)

Three Point Solutions

Medical Assembler

Brooklyn Park, MN · On-site

$18 - $20/hr

Complete accurate manufacturing records such as Device History Records and Lot Control documentation. * Communicate effectively with supervisors and team members; understand and execute verbal and ...

Cube Hub Inc.

Quality Inspector - III

Medina, NY · On-site

$20 - $25/hr

This role is responsible for reviewing Device History Records (DHR), inspecting products for compliance, documenting nonconformances, and ensuring products meet FDA and cGMP requirements prior to ...

Covenant Health

ASSEMBLY TECH I

Knoxville, TN · On-site

$16.75 - $21/hr

Responsible for appropriate documentation of Device History Record and the Non-Conformance Manual in accordance with department Standard Operating Procedure and FDA Regulations. * Required to aid in ...

Covenant Health

ASSEMBLY TECH I

Knoxville, TN · On-site

$16.75 - $21/hr

Responsible for appropriate documentation of Device History Record and the Non-Conformance Manual in accordance with department Standard Operating Procedure and FDA Regulations. * Required to aid in ...

Kelly Services

Quality Engineer

Austin, TX

$71K - $92K/yr

Develop and revise device history records, work instructions, validation protocols, and training certification documents for the new site. Collaborate closely with R&D, operations, manufacturing ...

New

Kelly Services

Quality Engineer

Austin, TX

$71K - $92K/yr

Develop and revise device history records, work instructions, validation protocols, and training certification documents for the new site. Collaborate closely with R&D, operations, manufacturing ...

New

Artech

MES Consultant - Critical Manufacturing

Boise, ID · On-site

$45 - $52/hr

... Device History Record (DHR) and traceability requirements • Develop and manage Master Batch Records (MBR) and Electronic Batch Records (EBR) Essential Skills: CMF Consultant MES Skills: EIS

Three Point Solutions

Medical Assembler

Brooklyn Park, MN · On-site

$20 - $22/hr

Maintains accurate production documentation (Device History Records, Data Sheets, Lot Control) * Follows priorities, schedules, assignments, job standards * Learns and adapts to new procedures and ...

millenniumsoft

Assembler - Urgent Need

Tempe, AZ · On-site

$15.25 - $19/hr

Essential Job Functions • Accurately complete Device History Records and associated paperwork • Assist with projects and qualifications concerning the process when needed • Communicate ...

SGS Consulting

Document Control Coordinator

Carlsbad, CA · On-site

... Device History Records as well as other quality system documents such as training records, monitoring records, authorized signature lists, etc. • Assist with new part number assignment process by ...

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Device History Record information

What is the difference between Device History Record vs Manufacturing Technician?

Device History RecordManufacturing Technician
Records detailed manufacturing data for each device, including process steps, inspections, and deviations.Performs manufacturing tasks, operates equipment, and ensures production meets quality standards.

Device History Records focus on documenting the manufacturing process for compliance and traceability, while Manufacturing Technicians execute those processes on the production line. Both roles are essential in regulated industries like medical device manufacturing, but they serve different functions: one is record-keeping, the other is hands-on production.

What are some common challenges faced when maintaining Device History Records, and how can they be addressed?

Maintaining Device History Records (DHRs) can be challenging due to the need for meticulous documentation and strict adherence to regulatory requirements. Common issues include incomplete entries, inconsistent data formats, and difficulty in tracking revisions. These challenges can be addressed by implementing standardized procedures, regular training for staff, and utilizing electronic record-keeping systems that ensure accuracy and traceability. Collaboration with quality assurance and manufacturing teams is also essential to ensure that all records are up-to-date and compliant.

What are the key skills and qualifications needed to thrive as a Device History Record (DHR) Specialist, and why are they important?

To thrive as a Device History Record (DHR) Specialist, you need a solid understanding of manufacturing processes, quality assurance, and regulatory compliance, typically supported by experience in the medical device or pharmaceutical industry. Familiarity with electronic documentation systems, Good Manufacturing Practices (GMP), and FDA regulations is essential. Attention to detail, organizational skills, and effective communication are critical soft skills for ensuring accurate and timely record-keeping. These skills and qualities are vital to maintain product traceability, ensure regulatory compliance, and uphold quality standards in highly regulated environments.

What are Device History Records?

Device History Records (DHRs) are detailed documents that track the manufacturing history of a medical device. They include information such as the dates of manufacture, the quantity manufactured, the lot or serial numbers, and records of inspection and testing. DHRs are required by regulatory agencies like the FDA to ensure each device is produced according to approved specifications and quality standards. Maintaining accurate DHRs helps ensure device traceability, supports recalls if necessary, and demonstrates compliance with quality system regulations.
What cities are hiring for Device History Record jobs? Cities with the most Device History Record job openings:
Infographic showing various Device History Record job openings in the United States as of May 2026, with employment types broken down into 2% As Needed, 78% Full Time, 14% Part Time, and 6% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution.
Medical Assembler

Medical Assembler

Three Point Solutions

Brooklyn Park, MN • On-site

$18 - $20/hr

Contractor

Posted 29 days ago

Job description

Job Title:         Medical Assembler
Client:              Medical Device Manufacturing Company
Location:         Brooklyn Park, MN 55445
Duration:         12 months, with possible extension
Shift:                1st Shift

Summary:
The Medical Assembler II supports manufacturing operations by assembling medical devices on multiple product lines, operating precision manufacturing and measurement equipment, and maintaining compliance with quality and cleanroom standards. The role requires adherence to documented procedures, accurate record keeping, and effective communication within the team.

Key Responsibilities:

  • Assemble medical devices at or above standard quantity rates across two or more product lines.
  • Operate equipment including microscopes, ultrasonic welders, soldering irons, dial calipers, and test instruments.
  • Follow and maintain adherence to Quality System Policies, Good Documentation Practice, and Lean Manufacturing principles.
  • Complete accurate manufacturing records such as Device History Records and Lot Control documentation.
  • Communicate effectively with supervisors and team members; understand and execute verbal and written instructions.
  • Perform repetitive tasks in a cleanroom environment while maintaining confidentiality and quality standards.

Qualifications:

  • High school diploma or equivalent preferred; 1–2 years’ experience in medical or ISO-certified assembly required.
  • Alternatively, 2–3 years’ assembly experience without diploma accepted.
  • Basic math skills and proficiency in MS Windows and site-specific PC programs.
  • Fine motor skills, dexterity, and eye-hand coordination to handle small parts.

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