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Manager Medical Device Operations Jobs in Texas (NOW HIRING)

Actalent

Device Technician

Austin, TX · On-site

$25 - $28/hr

... device management activities.Responsibilities: * Supports installation activities for plasma ... Performs installation verification, operational qualification activities, functional testing, and ...

Sotera Health

Manager Operations

Fort Worth, TX · On-site

We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies. Sotera Health ...

Sotera Health

Manager Operations

Fort Worth, TX · On-site

We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies. Sotera Health ...

Edwards Lifesciences Corporation

Expert knowledge of the FDA's Quality System Regulations; experience working within a Quality Management System. Strong working knowledge of Medical Device regulations, such as FDA 21 CFR 820, ISO ...

New

Crown Medical, Inc.

Medical Orthopedic Rep

Beaumont, TX · On-site

$60 - $80/hr

Medical Sales Territory Representative - Entry Level We are a leading Medical Device and Equipment ... Ability to effectively manage a physician‑based customer base. * Skills to communicate clinically ...

Aerotek

Cleanroom Assembler

Austin, TX · On-site

$19 - $20/hr

Cleanroom Assembler Join a growing medical device manufacturer and help build innovative, life ... Experience with production, assembly, and machine operation in a manufacturing setting.

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All JobsMedical Device Operations JobsManager Medical Device Operations JobsManager Medical Device Operations Jobs in Texas

Manager Medical Device Operations information

What is a manager medical device operations?

A Manager Medical Device Operations oversees the daily activities and processes involved in manufacturing, distributing, and maintaining medical devices. They ensure that operations comply with regulatory standards, manage teams, and work to optimize efficiency, quality, and safety. This role often involves coordinating with other departments, handling audits, and implementing process improvements to meet organizational goals. They play a critical role in ensuring that medical devices reach healthcare providers and patients safely and on time.

What are the key skills and qualifications needed to thrive as a manager medical device operations?

To excel as a Manager Medical Device Operations, you need expertise in supply chain management, regulatory compliance (such as FDA and ISO standards), and operational leadership, typically supported by a bachelor’s degree in engineering, life sciences, or business. Familiarity with ERP systems, quality management software, and relevant certifications like Six Sigma or PMP are commonly required. Strong communication, problem-solving, and team leadership skills help drive cross-functional collaboration and continuous improvement. These competencies are essential for ensuring product quality, regulatory adherence, and efficient operations in a highly regulated industry.

What are some common challenges faced by a manager medical device operations, and how can they be addressed?

Managers in Medical Device Operations often face challenges such as ensuring compliance with strict regulatory standards, coordinating cross-functional teams, and managing supply chain complexities. Staying proactive with regulatory updates, fostering open communication among departments, and implementing robust quality management systems can help address these issues. Additionally, investing in staff training and process improvement initiatives can streamline operations and minimize delays or compliance risks.

What are popular job titles related to Manager Medical Device Operations jobs in Texas?

For Manager Medical Device Operations jobs in Texas, the most frequently searched job titles are:

What job categories do people searching Manager Medical Device Operations jobs in Texas look for?

The top searched job categories for Manager Medical Device Operations jobs in Texas are:

What cities in Texas are hiring for Manager Medical Device Operations jobs?

Cities in Texas with the most Manager Medical Device Operations job openings:

Manager Medical Device Operations jobs near you
Infographic showing various Manager Medical Device Operations job openings in Texas as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 92% Physical, 1% Hybrid, and 7% Remote job distribution.

Medical Device Quality Remediation Consultants (Hybrid)

The FDA Group

Fort Worth, TX • On-site

Full-time, Part-time

Posted 17 days ago

Job description

Medical Device Quality Remediation Consultants

Location: North of Fort Worth, TX
Work Arrangement: Primarily Onsite / Hybrid Flexibility
Duration: Initial 3-month engagement with potential extension to 6+ months
Openings: 2 Consultants
Start: ASAP / Within the next few weeks
Schedule: Full-time preferred; qualified part-time consultants may also be considered

Position Overview

We are seeking two experienced Medical Device Quality Remediation Consultants to support a quality systems remediation initiative at a medical device organization in Texas.

The consultants will provide hands-on support addressing CAPA and complaint backlogs, FDA remediation activities, quality and regulatory records, and implementation of FDA Quality Management System Regulation (QMSR) requirements.

This engagement requires professionals who can move beyond high-level strategy and actively drive remediation activities through completion. The ideal consultants will be able to identify root causes, develop practical and sustainable corrective actions, and work collaboratively with site personnel to strengthen the overall Quality Management System.

Key Responsibilities

  • Drive investigation, remediation, and closure of open and aging CAPAs.
  • Address existing complaint-handling backlogs and support timely closure of complaint records.
  • Evaluate and improve complaint-handling processes to promote sustainable compliance.
  • Perform and/or support root-cause investigations and development of effective corrective actions.
  • Support remediation activities resulting from FDA inspection observations.
  • Assist with quality and regulatory record management and remediation.
  • Support implementation and integration of FDA QMSR requirements into the existing Quality Management System.
  • Ensure remediation activities align with applicable FDA requirements and ISO 13485.
  • Identify systemic quality issues and develop practical corrective actions that address underlying causes rather than short-term fixes.
  • Collaborate with Quality, Regulatory, Operations, and other cross-functional stakeholders to drive remediation activities to completion.

Required Qualifications

  • Significant medical device industry experience.
  • Strong working knowledge of ISO 13485.
  • Strong knowledge of 21 CFR Part 820 and FDA QMSR requirements.
  • Demonstrated hands-on experience with CAPA remediation and closure.
  • Strong complaint handling and complaint investigation experience.
  • Experience supporting remediation following FDA inspections and observations.
  • Experience with quality records and regulatory documentation.
  • Strong root-cause analysis, investigation, and problem-solving capabilities.
  • Ability to develop sustainable, compliant solutions and effectively drive them through implementation.
  • Comfortable working in a hands-on consulting environment with significant interaction with site personnel.

Work Arrangement

This engagement will require frequent onsite presence in Texas. Some administrative and documentation activities may be completed remotely when appropriate.

Local candidates are preferred; however, travel can be accommodated for highly qualified consultants who are not located in the area.

Ideal Candidate

The ideal consultant is a seasoned medical device Quality Systems/Remediation professional with substantial hands-on experience in CAPA, complaints, FDA remediation, ISO 13485, and FDA QMSR/21 CFR Part 820.