Medical Device Quality Systems & FDA Inspection Readiness Consultant Location: Atlanta/Duluth ... Develop new quality and operational processes needed to support manufacturing and distribution ...
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Medical Device Quality Systems & FDA Inspection Readiness Consultant Location: Atlanta/Duluth ... Develop new quality and operational processes needed to support manufacturing and distribution ...
Quick apply
Medical Device Quality Systems & FDA Inspection Readiness Consultant Location: Atlanta/Duluth ... Develop new quality and operational processes needed to support manufacturing and distribution ...
Santa Rosa, CA · On-site
$22 - $24/hr
This role supports manufacturing operations by performing quality checks, assisting with ... Assemble medical device products using approved manufacturing procedures and documentation. * Work ...
Santa Rosa, CA · On-site
$22 - $24/hr
This role supports manufacturing operations by performing quality checks, assisting with ... Assemble medical device products using approved manufacturing procedures and documentation. * Work ...
Irvine, CA · On-site
$17 - $19/hr
Medical Device Assembler Location: Irvine, CA 92614 Employment Type: W2 Contract | 6 Months with ... Prioritize assigned work to support production schedules and operational goals. * Participate in ...
New
Irvine, CA · On-site
$17 - $19/hr
Medical Device Assembler Location: Irvine, CA 92614 Employment Type: W2 Contract | 6 Months with ... Prioritize assigned work to support production schedules and operational goals. * Participate in ...
New
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Irvine, CA · On-site
$17 - $19/hr
Medical Device Assembler Location: Irvine, CA 92614 Employment Type: W2 Contract | 6 Months with ... Prioritize assigned work to support production schedules and operational goals. * Participate in ...
New
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Irvine, CA · On-site
$17 - $19/hr
Medical Device Assembler Location: Irvine, CA 92614 Employment Type: W2 Contract | 6 Months with ... Prioritize assigned work to support production schedules and operational goals. * Participate in ...
New
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Temecula, CA · On-site
$19.25 - $23.33/hr
Medical Device Assembler Location: Temecula, CA Employment Type: Full-Time / Contract Pay Rate: $19 ... operations in a regulated cleanroom environment. This is an excellent opportunity for candidates ...
New
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Temecula, CA · On-site
$19.25 - $23.33/hr
Medical Device Assembler Location: Temecula, CA Employment Type: Full-Time / Contract Pay Rate: $19 ... operations in a regulated cleanroom environment. This is an excellent opportunity for candidates ...
New
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Temecula, CA · On-site
$19.25 - $23.33/hr
Medical Device Assembler Location: Temecula, CA Employment Type: Full-Time / Contract Pay Rate: $19 ... operations in a regulated cleanroom environment. This is an excellent opportunity for candidates ...
New
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Temecula, CA · On-site
$19.25 - $23.33/hr
Medical Device Assembler Location: Temecula, CA Employment Type: Full-Time / Contract Pay Rate: $19 ... operations in a regulated cleanroom environment. This is an excellent opportunity for candidates ...
New
Plymouth, MN · On-site
$16.75 - $18.75/hr
Perform routine precision assembly and manufacturing operations. * Handle and assemble small ... Medical device manufacturing experience. * Previous microscope assembly or inspection experience.
New
Plymouth, MN · On-site
$16.75 - $18.75/hr
Perform routine precision assembly and manufacturing operations. * Handle and assemble small ... Medical device manufacturing experience. * Previous microscope assembly or inspection experience.
New
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Plymouth, MN · On-site
$16.75 - $18.75/hr
Perform routine precision assembly and manufacturing operations. * Handle and assemble small ... Medical device manufacturing experience. * Previous microscope assembly or inspection experience.
New
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Plymouth, MN · On-site
$16.75 - $18.75/hr
Perform routine precision assembly and manufacturing operations. * Handle and assemble small ... Medical device manufacturing experience. * Previous microscope assembly or inspection experience.
New
Plymouth, MN · On-site
$18.75/hr
Ensure consistent hand-eye coordination for accuracy in all assembly operations * Support quality ... medical device assembly * High School Diploma, GED, or equivalent experience * Proficient in ...
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Plymouth, MN · On-site
$18.75/hr
Ensure consistent hand-eye coordination for accuracy in all assembly operations * Support quality ... medical device assembly * High School Diploma, GED, or equivalent experience * Proficient in ...
Westford, MA · On-site
$19 - $21.51/hr
Perform assembly, repair, and testing operations on catheters and related medical device assemblies. * Follow established manufacturing procedures, work instructions, safety requirements, and quality ...
Westford, MA · On-site
$19 - $21.51/hr
Perform assembly, repair, and testing operations on catheters and related medical device assemblies. * Follow established manufacturing procedures, work instructions, safety requirements, and quality ...
Arvada, CO · On-site
$19.50 - $21/hr
Medical Device Production Assembler Build Products That Help Change Lives Arvada, CO | Full-Time ... Collaborate closely with engineering, quality, and operations teams. * Take ownership of your work ...
Arvada, CO · On-site
$19.50 - $21/hr
Medical Device Production Assembler Build Products That Help Change Lives Arvada, CO | Full-Time ... Collaborate closely with engineering, quality, and operations teams. * Take ownership of your work ...
$16 - $19/hr
Working under close supervision, may perform a combination of assembly, repair, and test operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical device ...
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$16 - $19/hr
Working under close supervision, may perform a combination of assembly, repair, and test operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical device ...
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Westford, MA · On-site
$19 - $21.50/hr
Perform assembly, repair, and testing operations on catheters and related medical device assemblies. * Follow established manufacturing procedures, work instructions, safety requirements, and quality ...
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Be Seen First
Westford, MA · On-site
$19 - $21.50/hr
Perform assembly, repair, and testing operations on catheters and related medical device assemblies. * Follow established manufacturing procedures, work instructions, safety requirements, and quality ...
$19.50 - $21/hr
Medical Device Production Assembler Build Products That Help Change Lives Arvada, CO | Full-Time ... Collaborate closely with engineering, quality, and operations teams. * Take ownership of your work ...
$19.50 - $21/hr
Medical Device Production Assembler Build Products That Help Change Lives Arvada, CO | Full-Time ... Collaborate closely with engineering, quality, and operations teams. * Take ownership of your work ...
Be Seen First
Atlanta, GA · On-site
$100K - $250K/yr
Medical Device Sales Representative Territory: Southeastern states Employment Type: Full-Time ... Collaborate with marketing, clinical, and operations teams to support product launches and growth ...
Quick apply
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Atlanta, GA · On-site
$100K - $250K/yr
Medical Device Sales Representative Territory: Southeastern states Employment Type: Full-Time ... Collaborate with marketing, clinical, and operations teams to support product launches and growth ...
$18.75/hr
This role is with a leading medical device manufacturing organization, is seeking Operators to join ... Maintain accurate documentation for all manufacturing operations * Communicate effectively with ...
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$18.75/hr
This role is with a leading medical device manufacturing organization, is seeking Operators to join ... Maintain accurate documentation for all manufacturing operations * Communicate effectively with ...
Eden Prairie, MN · On-site
$18.25 - $22.50/hr
The Medical Device Assembler I is responsible for performing a variety of production tasks related ... Standard Operation Procedures (SOP), Work Instructions (WI), Engineering Prints and Bills of ...
Eden Prairie, MN · On-site
$18.25 - $22.50/hr
The Medical Device Assembler I is responsible for performing a variety of production tasks related ... Standard Operation Procedures (SOP), Work Instructions (WI), Engineering Prints and Bills of ...
Eden Prairie, MN · On-site
$18.25 - $22.50/hr
The Medical Device Assembler I is responsible for performing a variety of production tasks related ... Standard Operation Procedures (SOP), Work Instructions (WI), Engineering Prints and Bills of ...
Eden Prairie, MN · On-site
$18.25 - $22.50/hr
The Medical Device Assembler I is responsible for performing a variety of production tasks related ... Standard Operation Procedures (SOP), Work Instructions (WI), Engineering Prints and Bills of ...
Minnetonka, MN · On-site
$18.75 - $19.25/hr
Partners Personnel has partnered with a global leader in medical device manufacturing to hire ... room operations remain current and compliant. Requirements: * Ability to read, write, and ...
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Minnetonka, MN · On-site
$18.75 - $19.25/hr
Partners Personnel has partnered with a global leader in medical device manufacturing to hire ... room operations remain current and compliant. Requirements: * Ability to read, write, and ...
Support equipment lifecycle validation activities for commercial medical device operations * Execute validation protocols and ensure compliance with regulatory standards Required Qualifications
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Support equipment lifecycle validation activities for commercial medical device operations * Execute validation protocols and ensure compliance with regulatory standards Required Qualifications
$11.30 - $15.12
9% of jobs
$17.62 is the 25th percentile. Wages below this are outliers.
$15.12 - $18.95
24% of jobs
The median wage is $21.86 / hr.
$18.95 - $22.77
22% of jobs
$22.77 - $26.60
16% of jobs
$28.29 is the 75th percentile. Wages above this are outliers.
$26.60 - $30.42
9% of jobs
$30.42 - $34.24
7% of jobs
$34.24 - $38.07
4% of jobs
$38.07 - $41.89
4% of jobs
$41.89 - $45.72
3% of jobs
$45.72 - $49.54
1% of jobs
$49.54 - $53.37
0% of jobs
$11
$26
$53
| Aspect | Medical Device Operations | Medical Device Quality Assurance |
|---|---|---|
| Primary Focus | Managing manufacturing, supply chain, and product deployment | Ensuring product quality, compliance, and safety standards |
| Required Certifications | Regulatory knowledge, manufacturing certifications | Quality management certifications, ISO standards |
| Work Environment | Manufacturing plants, supply chain settings | Quality labs, compliance departments |
| Industry Usage | Used across production and logistics teams | Used within quality control and regulatory teams |
Medical Device Operations and Medical Device Quality Assurance roles often overlap but focus on different aspects of the product lifecycle. Operations centers on manufacturing and logistics, while Quality Assurance emphasizes compliance and safety. Both roles require regulatory knowledge and are essential in the medical device industry.
Cities with the most Medical Device Operations job openings:
The most popular types of Medical Device Operations jobs are:
States with the most job openings for Medical Device Operations jobs include:
The top searched job categories for Medical Device Operations jobs are:

Full-time
Posted 8 days ago
Medical Device Quality Systems & FDA Inspection Readiness Consultant
Location: Atlanta/Duluth, Georgia area
Work Arrangement: Onsite
Duration: Immediate start through November 2026, with potential extension
Start: Immediate
Position Overview
We are seeking an experienced Medical Device Quality Systems Consultant to provide hands-on support for the startup of a new Class I medical device contract manufacturing operation.
The consultant will support Quality Management System (QMS) implementation, development of auditable quality and operational processes, system validation, and FDA inspection readiness. A key focus will be ensuring appropriate controls are established across production, warehousing, inventory, traceability, product hold/quarantine, release, and direct-to-consumer distribution activities.
The engagement will require both quality systems expertise and practical implementation support as the organization works toward regulatory and operational milestones in October and a planned November 1 go-live. The consultant may also provide training and ongoing Quality support following launch.
Key Responsibilities
Review the existing QMS and tailor requirements and processes for the new medical device manufacturing operation.
Support implementation of the QMS and ensure processes are operational, documented, and auditable.
Develop new quality and operational processes needed to support manufacturing and distribution activities.
Support validation of the warehouse management system and associated workflows.
Establish and/or assess controls for production, inventory management, product traceability, quarantine/hold, and product release.
Develop appropriate quality checks and controls for direct-to-consumer product shipments.
Assess Quality System and operational readiness for an anticipated FDA inspection.
Identify inspection-readiness gaps and support implementation of corrective actions before go-live.
Work directly with facility personnel to operationalize new procedures and quality controls.
Provide employee training and implementation support for new or revised processes, as needed.
Support the organization through its planned November 1 launch and provide ongoing Quality support following go-live, as needed.
Required Qualifications
Significant medical device Quality or Quality Systems experience.
Demonstrated experience implementing or adapting a QMS for medical device operations.
Strong knowledge of FDA medical device quality requirements and inspection readiness.
Experience developing and implementing auditable quality and operational processes.
Experience with warehouse, distribution, inventory, traceability, quarantine/hold, and product release controls.
Experience supporting computerized system validation or validation of warehouse/inventory management systems.
Ability to provide hands-on implementation support and work directly with site personnel.
Ability to work onsite in the Atlanta/Duluth, Georgia area.
Preferred Qualifications
Experience supporting startup or launch activities for a medical device manufacturing operation.
Experience with Class I medical devices.
Experience establishing quality controls for direct-to-consumer distribution.
Local to the Atlanta/Duluth, Georgia area.
Work Arrangement
This engagement requires onsite support in the Atlanta/Duluth, Georgia area. Local consultants are preferred to facilitate consistent onsite support.
Ideal Candidate
The ideal consultant is a hands-on Medical Device Quality Systems professional with experience taking QMS requirements from documented procedures through practical implementation. The consultant should be comfortable working across quality systems, warehouse and distribution controls, system validation, and FDA inspection readiness while helping a new manufacturing operation prepare for launch.
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Recruiting and staffing services
11 - 50 Employees
Westborough, MA, US
2007