Job Details

ID #23696803
State Florida
City Clearwater
Job type Permanent
Salary USD Depends on Experience Depends on Experience
Source Advent Global Solutions, Inc.
Showed 2021-12-01
Date 2021-11-18
Deadline 2022-01-17
Category Et cetera
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Quality Manager- Medical Device

Florida, Clearwater, 33755 Clearwater USA

Vacancy expired!

Position: Quality Manager- Medical Device

Location: Clearwater, FL

Duration: Fulltime

SUMMARYLead WHK QA Department to assure compliance with the Quality Management System by performing the following duties personally or through WHK Employees/QA Inspectors.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.5 years of managing people in a regulated industry, medical device or pharmaceutical.Cleanroom and sterilization management experience.Validation experience.Prepare documentation for MRB meeting; run meeting; process NMRs; follow-up on action items; and update NMR database.Run Corrective Action meeting; follow-up with corrective action assignees.Conduct ISO Awareness Training.Supervise WHK supplier evaluations and audits.Develop, implement, and coordinate control plans and documentation for new and existing manufactured parts.Develop and maintain visual aids for defect recognition.Train appropriate personnel on the use of the visual aids for defect recognition system.Develop and maintain operation specific work instructions and inspection standards.Train appropriate personnel on the use of these work instructions and inspection standards.Conduct capability studies, analyse results and report results as needed to President/Managing Member and other key divisional managers as directed.Create and maintain control plans and control charts as necessary.Identify critical characteristics to be inspected for each part run in WHK manufacturing.Conduct root cause analysis for discrepancies and issue corrective action when deemed necessary.Review blueprints and customer standards during the quoting process to ensure inspection criteria can be met without incurring additional costs.Work directly with Operations during quoting process to help determine potential problems during product development and processing.Provide technical assistance to Quality Control personnel and all departments.Update, evaluate returned product under RMA process; interface with customer service and/or customer as necessary.Perform receiving inspection.Communicate effectively with customers on quality related problems.Lead the initiative to drive down defect rates by determining which parts need attention.As a team leader, working directly with involved departments, the Quality Manager is to systematically identify and correct the root cause of all product defects.

EDUCATION AND/OR EXPERIENCEFour year degree in engineering, science or technical field. An understanding of blueprint interpretation and Geometric Dimensioning and Tolerancing is mandatory. A minimum of five years' experience in a related position within a Quality Assurance Department is required. Must be able to interpret blueprints in accordance with ANSI Y14.5. Must have a strong knowledge of ISO 13485 and other quality systems.

CERTIFICATES, LICENSES, REGISTRATIONSAn active membership in the American Society for Quality (ASQ) and an ASQ CQE are a plus.

Alex G.

Senior Talent Acquisition Specialist

Advent Global Solutions Inc.,Direct: www.adventglobal.com

Vacancy expired!

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