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Manager Medical Device Operations Jobs in Washington

Caraballo Consulting & Associates L

Be Seen First

QA Manufacturing Engineer - Medical Device

Sterling, VA · On-site

$40 - $80/hr

... up manufacturing operations at the new site. * Review, execute, and approve validation ... Complete the bulk download of documents and records from a Quality Management System. Required ...

Caraballo Consulting & Associates L

Be Seen First

QA Manufacturing Engineer - Medical Device

Sterling, VA · On-site

$40 - $80/hr

... up manufacturing operations at the new site. * Review, execute, and approve validation ... Complete the bulk download of documents and records from a Quality Management System. Required ...

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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 Washington?

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

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

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

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

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

Manager Medical Device Operations jobs near you

Senior Validation Engineer - Medical Devices

Stark Pharma Solutions Inc

Silver Spring, MD • On-site

Contractor

Re-posted 29 days ago

Job description

Job Title: Senior Validation Engineer – Medical Devices

Location: Silver Spring, MD (Onsite)

Duration: 06 months contract (High potential for extension)

Job Summary

We are seeking a Senior Validation Engineer to support equipment lifecycle management, facility changes, and commercialization activities within a medical device environment. This role will play a key part in ensuring equipment and systems are validated, compliant, and maintained in a validated state throughout their lifecycle.

The ideal candidate will have strong experience in validation documentation, equipment qualification, and cross-functional collaboration within regulated environments.

Key Responsibilities

Validation & Documentation

  • Develop, review, and execute validation documents including:
    • User Requirement Specifications (URS)
    • Validation Determination Assessments (VDA)
    • Installation, Operational, and Performance Qualifications (IQ/OQ/PQ)
    • Requirements Traceability Matrix (RTM)
    • Final/Summary Reports
  • Support equipment lifecycle validation activities for commercial medical device operations
  • Execute validation protocols and ensure compliance with regulatory standards

Required Qualifications

  • Minimum 5+ years of experience in validation within medical device or regulated environments
  • Strong experience with equipment lifecycle management and validation documentation
  • Hands-on experience with IQ/OQ/PQ, URS, RTM, and validation reporting
  • Experience supporting commercialization, facility changes, or system transitions
  • Knowledge of GMP, FDA, and quality system requirements
  • Strong collaboration, communication, and problem-solving skills