The consultant will support Quality Management System (QMS) implementation, development of ... Develop appropriate quality checks and controls for direct-to-consumer product shipments. * Assess ...
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The consultant will support Quality Management System (QMS) implementation, development of ... Develop appropriate quality checks and controls for direct-to-consumer product shipments. * Assess ...
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The consultant will support Quality Management System (QMS) implementation, development of ... Develop appropriate quality checks and controls for direct-to-consumer product shipments. * Assess ...
$153K - $199K/yr
The Associate Director, Quality Medical Device Engineer will lead quality oversight activities for ... Ensure compliance with FDA 21 CFR Part 4, 21 CFR Part 820/Quality Management System Regulation ...
$153K - $199K/yr
The Associate Director, Quality Medical Device Engineer will lead quality oversight activities for ... Ensure compliance with FDA 21 CFR Part 4, 21 CFR Part 820/Quality Management System Regulation ...
Allentown, PA · On-site
$260K - $290K/yr
Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and ... Develop, maintain, and report medical device-specific quality metrics (e.g., NC/CAPA trends ...
Allentown, PA · On-site
$260K - $290K/yr
Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and ... Develop, maintain, and report medical device-specific quality metrics (e.g., NC/CAPA trends ...
$260K - $290K/yr
Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and ... Provide executivelevel reporting on device quality performance, compliance risks, manufacturing ...
$260K - $290K/yr
Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and ... Provide executivelevel reporting on device quality performance, compliance risks, manufacturing ...
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Sterling, VA · On-site
$40 - $80/hr
... Medical Device company. The perfect candidate will perform the following activities: Key ... Complete the bulk download of documents and records from a Quality Management System. Required ...
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Sterling, VA · On-site
$40 - $80/hr
... Medical Device company. The perfect candidate will perform the following activities: Key ... Complete the bulk download of documents and records from a Quality Management System. Required ...
Be Seen First
Sterling, VA · On-site
$40 - $80/hr
... Medical Device company. The perfect candidate will perform the following activities: Key ... Complete the bulk download of documents and records from a Quality Management System. Required ...
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Sterling, VA · On-site
$40 - $80/hr
... Medical Device company. The perfect candidate will perform the following activities: Key ... Complete the bulk download of documents and records from a Quality Management System. Required ...
Reporting to the Senior Director of Device Quality and Regulatory (DQ&R), the Associate Director ... Medical Device Management, Medical Device Regulations, Medical Devices, Product Development ...
Reporting to the Senior Director of Device Quality and Regulatory (DQ&R), the Associate Director ... Medical Device Management, Medical Device Regulations, Medical Devices, Product Development ...
Zebulon, GA · On-site
$79K - $107K/yr
... medical devices within combination products. Responsibilities include risk management ... including direct experience in manufacturing and quality oversight of medical devices.
Zebulon, GA · On-site
$79K - $107K/yr
... medical devices within combination products. Responsibilities include risk management ... including direct experience in manufacturing and quality oversight of medical devices.
Saint Augustine, FL · On-site
Medical Device Quality Engineer Position Type :Contract Projected Start Date :08-09-2017 Zip Code :33716 City :St. Petersburg State :FL Required Skills : ISO 9000 Not looking for a Design or testing ...
Saint Augustine, FL · On-site
Medical Device Quality Engineer Position Type :Contract Projected Start Date :08-09-2017 Zip Code :33716 City :St. Petersburg State :FL Required Skills : ISO 9000 Not looking for a Design or testing ...
Tempe, AZ · On-site
We partner with pharmaceutical, biotech, and medical device organizations to navigate complexity ... Develop, implement, maintain, and continuously improve the Quality Management System (QMS ...
Tempe, AZ · On-site
We partner with pharmaceutical, biotech, and medical device organizations to navigate complexity ... Develop, implement, maintain, and continuously improve the Quality Management System (QMS ...
Minneapolis, MN · On-site
$75K - $97K/yr
... a medical device environment. This role will partner cross-functionally to ensure compliance with ... Manage CAPAs, nonconformances, root cause investigations, and change controls * Support IQ/OQ/PQ ...
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Minneapolis, MN · On-site
$75K - $97K/yr
... a medical device environment. This role will partner cross-functionally to ensure compliance with ... Manage CAPAs, nonconformances, root cause investigations, and change controls * Support IQ/OQ/PQ ...
Irvine, CA · On-site
$19 - $21.50/hr
... quality results while using a microscope in a cleanroom environment. Essential Duties and ... Each branch is full-service, providing temporary, contract, contract-to-hire and direct placement ...
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Irvine, CA · On-site
$19 - $21.50/hr
... quality results while using a microscope in a cleanroom environment. Essential Duties and ... Each branch is full-service, providing temporary, contract, contract-to-hire and direct placement ...
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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 ... Support Quality Management System (QMS), Environmental Management System (EMS), and applicable ...
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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 ... Support Quality Management System (QMS), Environmental Management System (EMS), and applicable ...
Wixom, MI · On-site
$16 - $17/hr
Document production activities, lot traceability, and quality records per FDA and ISO regulations ... Prior experience in medical device assembly, electronics assembly, or precision manufacturing ...
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Wixom, MI · On-site
$16 - $17/hr
Document production activities, lot traceability, and quality records per FDA and ISO regulations ... Prior experience in medical device assembly, electronics assembly, or precision manufacturing ...
San Clemente, CA · On-site
$21 - $22/hr
Conduct visual inspections and quality checks * Test components and finished products using ... direct-hire staffing in the areas of office and administrative support, customer service ...
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San Clemente, CA · On-site
$21 - $22/hr
Conduct visual inspections and quality checks * Test components and finished products using ... direct-hire staffing in the areas of office and administrative support, customer service ...
Good Experience in 8+ years of Medical Device Quality Systems experience. * You should have a Minimum 3 years of CAPA management experience. * Strong Experience supporting regulatory audits and ...
New
Good Experience in 8+ years of Medical Device Quality Systems experience. * You should have a Minimum 3 years of CAPA management experience. * Strong Experience supporting regulatory audits and ...
New
Longview, TX · On-site
$64K - $82K/yr
... medical device expectations. § Lead and manage direct and indirect reports within the facility to meet or exceed targets for the medical device quality management system. § Maintain all aspects of ...
Longview, TX · On-site
$64K - $82K/yr
... medical device expectations. § Lead and manage direct and indirect reports within the facility to meet or exceed targets for the medical device quality management system. § Maintain all aspects of ...
$75K - $115K/hr
Driven by our commitment to Quality, Clinically Relevant Innovation, and Simplicity, we are more ... Regional Sales Director - GI Why Join PENTAX Medical? At PENTAX Medical, your work has purpose.
$75K - $115K/hr
Driven by our commitment to Quality, Clinically Relevant Innovation, and Simplicity, we are more ... Regional Sales Director - GI Why Join PENTAX Medical? At PENTAX Medical, your work has purpose.
Itasca, IL · On-site
... other relevant medical device standards. ● Develop, implement, and maintain quality system ... Direct experience managing CAPA, complaints, post-market surveillance systems, and MDR/adverse ...
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Itasca, IL · On-site
... other relevant medical device standards. ● Develop, implement, and maintain quality system ... Direct experience managing CAPA, complaints, post-market surveillance systems, and MDR/adverse ...
$16.75 - $20.25/hr
Medical Device Assembler (Assembling under a microscope, experience required) The Cleanroom ... Conduct visual inspections under a microscope to verify product quality and ensure conformance to ...
New
Quick apply
$16.75 - $20.25/hr
Medical Device Assembler (Assembling under a microscope, experience required) The Cleanroom ... Conduct visual inspections under a microscope to verify product quality and ensure conformance to ...
New
$31K - $47.6K
4% of jobs
$47.6K - $64.2K
4% of jobs
$64.2K - $80.8K
8% of jobs
$89.3K is the 25th percentile. Wages below this are outliers.
$80.8K - $97.4K
16% of jobs
$97.4K - $114K
13% of jobs
The median wage is $119.7K / yr.
$114K - $130.5K
14% of jobs
$130.5K - $147.1K
16% of jobs
$147.6K is the 75th percentile. Wages above this are outliers.
$147.1K - $163.7K
11% of jobs
$163.7K - $180.3K
6% of jobs
$180.3K - $196.9K
5% of jobs
$196.9K - $213.5K
3% of jobs
$31K
$125.6K
$213.5K
For Medical Device Quality Director Manager jobs, the most frequently searched job titles are:
Atlanta, GA • On-site
Full-time
Posted 16 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