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Traceability Manager Jobs in Florida (NOW HIRING)

Apex Systems

Quality Control Associate I

Riverview, FL · On-site

$21 - $24/hr

Product traceability management * Statistical sampling procedures * Process monitoring and continuous improvement * Manufacturing and production support * Regulatory and quality system compliance ...

GA Telesis

Materials Manager

Fort Lauderdale, FL · On-site

The Materials Manager will ensure an efficient flow of materials to support production schedules ... Maintain documentation and traceability for all materials used in MRO operations. * Supervise and ...

GA Telesis, LLC

Materials Manager

Fort Lauderdale, FL · On-site

The Materials Manager will ensure an efficient flow of materials to support production schedules ... Maintain documentation and traceability for all materials used in MRO operations. * Supervise and ...

AP4 Group LLC

Material Manager

Lakeland, FL · On-site

$1.5K/wk

The role manages receiving, material traceability, storage, preservation, and release in accordance with OEM specifications, project procedures, and international quality and EHS standards. Working ...

chromalloy

Manager Quality Assurance

Tampa, FL · On-site

Manager, Quality Assurance The Manager, Quality ensures the robustness of the site Quality ... Maintain end-to-end traceability and record control in compliance with FAA and AS9100 requirements.

chromalloy

Manager Quality Assurance

Tampa, FL

Manager, Quality Assurance The Manager, Quality ensures the robustness of the site Quality ... Maintain end-to-end traceability and record control in compliance with FAA and AS9100 requirements.

chromalloy

Manager Quality Assurance

Tampa, FL

Manager, Quality Assurance The Manager, Quality ensures the robustness of the site Quality ... Maintain end-to-end traceability and record control in compliance with FAA and AS9100 requirements.

chromalloy

Manager Quality Assurance

Tampa, FL · On-site

Manager, Quality Assurance The Manager, Quality ensures the robustness of the site Quality ... Maintain end-to-end traceability and record control in compliance with FAA and AS9100 requirements.

chromalloy

Manager Quality Assurance

Tampa, FL · On-site

Manager, Quality Assurance The Manager, Quality ensures the robustness of the site Quality ... Maintain end-to-end traceability and record control in compliance with FAA and AS9100 requirements.

chromalloy

Manager Quality Assurance

Tampa, FL · On-site

Manager, Quality Assurance The Manager, Quality ensures the robustness of the site Quality ... Maintain end-to-end traceability and record control in compliance with FAA and AS9100 requirements.

chromalloy

Manager Quality Assurance

Tampa, FL

Manager, Quality Assurance The Manager, Quality ensures the robustness of the site Quality ... Maintain end-to-end traceability and record control in compliance with FAA and AS9100 requirements.

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All JobsTraceability JobsTraceability Manager JobsTraceability Manager Jobs in Florida

Traceability Manager information

What are the key skills and qualifications needed to thrive as a Traceability Manager, and why are they important?

To thrive as a Traceability Manager, you need expertise in supply chain management, quality assurance, and data analysis, typically backed by a degree in logistics, business, or a related field. Familiarity with traceability software (such as ERP or specialized tracking systems), GS1 standards, and relevant industry certifications like Six Sigma or ISO are commonly required. Strong problem-solving, attention to detail, and effective communication skills help ensure compliance and foster collaboration across teams. These skills are vital to maintaining product integrity, regulatory compliance, and operational transparency throughout the supply chain.

What are some common challenges faced by Traceability Managers, and how can they be addressed?

Traceability Managers often face challenges such as integrating traceability systems across diverse supply chains, ensuring data accuracy, and meeting regulatory compliance. These challenges can be addressed by collaborating closely with IT and operations teams to standardize processes, implementing robust data verification protocols, and staying updated on industry regulations. Regular training and open communication with suppliers and internal stakeholders are also key to proactively identifying and resolving traceability issues.

What are Traceability Managers?

Traceability Managers are professionals responsible for ensuring that products, materials, or information can be accurately tracked throughout the supply chain. They develop and implement systems to monitor the movement and history of goods, ensuring compliance with regulations and industry standards. Their work helps organizations maintain transparency, improve quality control, and respond quickly to recalls or quality issues. Traceability Managers often collaborate with various departments, such as procurement, production, and quality assurance, to ensure seamless tracking processes.

What is the difference between Traceability Manager vs Quality Assurance Specialist?

AspectTraceability ManagerQuality Assurance Specialist
CertificationsISO 9001 Lead Auditor, Certified Quality ManagerASQ CQE, Six Sigma Green Belt
Work EnvironmentManufacturing, Supply Chain, Food IndustryManufacturing, Software, Healthcare
Employer UsageEnsures product traceability and complianceEnsures product quality and process improvements

The Traceability Manager focuses on tracking and documenting product movement throughout the supply chain, ensuring compliance and transparency. The Quality Assurance Specialist concentrates on testing, inspection, and maintaining product quality standards. While both roles aim to improve product integrity, the Traceability Manager emphasizes traceability systems, whereas the QA Specialist emphasizes quality control processes.

What are popular job titles related to Traceability Manager jobs in Florida? For Traceability Manager jobs in Florida, the most frequently searched job titles are:
What job categories do people searching Traceability Manager jobs in Florida look for? The top searched job categories for Traceability Manager jobs in Florida are:
What cities in Florida are hiring for Traceability Manager jobs? Cities in Florida with the most Traceability Manager job openings:
Traceability Manager jobs near you
Design Controls Specialist

Design Controls Specialist

AVEVA DRUG DELIVERY SYSTEMS INC

Miramar, FL • On-site

Full-time

Posted 28 days ago

Job description

Job Summary: 

The Design Controls Specialist is responsible for establishing, maintaining, and ensuring compliance of design control processes in accordance with regulatory requirements (FDA 21 CFR Part 820, ISO 13485, and applicable combination product guidelines). This role will own and manage Design History Files (DHF) and oversee product lifecycle management for transdermal drug delivery systems, ensuring traceability, risk management, and design integrity from concept through commercialization and post-market changes.

Job Responsibilities:

Design Control & Design History File (DHF) Management

  • Lead the creation, organization, review, and maintenance of Design History Files (DHF) for transdermal patch products.
  • Ensure DHFs demonstrate full compliance with:
    • FDA 21 CFR 820.30 (Design Controls)
    • ISO 13485 design and development requirements
    • Combination product regulations (21 CFR Part 4)
  • Maintain complete design traceability from:
    • User needs → Design inputs → Outputs → Verification → Validation → Design transfer
  • Perform routine audits and gap assessments of DHFs to ensure completeness and inspection readiness.
  • Ensure proper version control and document integrity within electronic document management systems (e.g. Trackwise).

Design Lifecycle Management

  • Support end-to-end product lifecycle management for transdermal patches:
    • Concept development
    • Feasibility and design planning
    • Verification & validation
    • Commercialization
    • Post-market lifecycle management
  • Drive and manage design changes (ECR/ECN) ensuring proper documentation, impact assessments, and approvals.
  • Collaborate with cross-functional teams to ensure lifecycle activities meet regulatory and quality expectations.

Risk Management & Compliance

  • Facilitate and maintain risk management documentation (ISO 14971 aligned), including:
    • Risk analyses (FMEA, FTA)
    • Risk control measures
    • Risk-benefit justifications
  • Ensure integration of risk management into design controls and lifecycle activities.
  • Support internal and external audits, including FDA inspections and notified body audits.
  • Act as subject matter expert on design control compliance for transdermal systems

Cross-Functional Collaboration

  • Partner with:
    • R&D / Formulation Scientists
    • Engineering (process, packaging, and equipment)
    • Quality Assurance & Regulatory Affairs
    • Manufacturing and Operations
  • Ensure alignment between product design, process design, and manufacturing transfer.
  • Support Design Transfer activities ensuring readiness for commercial production.

Documentation & Systems

  • Maintain and improve Quality Management System (QMS) procedures related to design controls.
  • Develop templates, SOPs, and best practices for DHF and lifecycle documentation.
  • Ensure all documentation supports labeling, stability, and performance requirements of transdermal patches.
  • Support digital transformation of DHF and lifecycle records when applicable.
  • All other duties as assigned.
Job Requirements
  • Bachelor’s degree in Engineering, Pharmaceutical Sciences, Life Sciences, or related field.
  • 3–7+ years of experience in:
    • Medical device, pharmaceutical, or combination product industries
    • Design controls and DHF management
  • Strong knowledge of:
    • FDA 21 CFR Part 820 and Part 4 (combination products)
    • ISO 13485 and ISO 14971
    • Design verification and validation processes
  • Experience with document control systems (e.g., TrackWise).

Knowledge, Skills and Abilities

  • Experience with transdermal drug delivery systems or combination products.
  • Knowledge of adhesives, drug-in-adhesive systems, or patch manufacturing technologies.
  • Familiarity with process validation and technology transfer
  • Experience supporting FDA inspections or regulatory submissions (e.g., NDA, ANDA, 510(k)).
  • Strong attention to detail and documentation rigor
  • Excellent organizational and traceability management skills
  • Ability to interpret and apply complex regulations
  • Cross-functional leadership and collaboration
  • Problem-solving and risk-based thinking
  • Audit readiness mindset

    Apply