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Job Title: Sr Quality Manager
Job ID: FL647
Location: Miami, FL
Industry: Medical Devices
Job Type: Full time
Description: 

 

Key Accountabilities:

 

  • Staff QA organization and establishes Quality System training requirements.

  • Implements Quality System, ensuring compliance and maintenance.

  • Responsible for all Quality Control functions, including In-Process, Quality Control, product release authorizations, and quarantine of all suspect or discrepant product.

  • Responsible for oversight of suppliers, maintaining the supplier selection process, qualification activities, quality agreements, and trending, including leading improvement activities and any Supplier CAPAs and nonconformance investigations.

  • Develops Quality Instructions and Quality Standards, and Quality Test Plans.

  • Reviews and approves documentation pertaining to product assembly, performance testing and evaluation.

  • Manages the control and maintenance of Quality System Records associated with product builds.

  • Manages Nonconformance process, including product quarantine and control.

    Identifies and evaluates fundamental compliance issues for major functional areas through assessment of quality system compliance.

    Establishes Quality Assurance objectives and assignments, and delegates assignments to subordinates.

    Oversees equipment and test method compliance used in Quality operations inspections/testing, including calibration, maintenance and validation.

    Involved in developing, modifying, and executing company policies.

    Regularly interacts with executive levels on matters concerning several functional areas, divisions and/or customers.

    Manages activities of two or more sections or departments through subordinates who exercise full supervision in terms of costs, methods, and employees.

    Makes final decisions on administrative or operational matters and ensures Quality Assurance(s) effective achievement of objectives.

 

 

Requirements: 

 

Minimum Knowledge & Experience required for the position:

 

  • A Bachelor’s degree or equivalent experience in Engineering, Quality Engineering or Sciences.

  • 10+ years of related experience in a regulated environment in Quality Assurance and or Manufacturing/ Engineering (design) environment.

  • Previous management/supervisory experience.

  • Regulatory Body Audit experience

 

Compensation: 

$130-$150k plus bonus

Contact: Jim Gurn
PO Box 3213
Boynton Beach
FL, 33424
Tel: (561) 200-0419
jbgurn@mricoastalgroup.com
Date Posted: 10/15/2018

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