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Quality Assurance Manager
$107k-135k (estimate)
Full Time 2 Days Ago
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Mackinnon Bruce International is Hiring a Quality Assurance Manager Near South Bend, IN

Quality Assurance Manager

Industry

Medical and Life Sciences – Diagnostics

Description

We are working alongside our key client in the Medical Diagnostic sector based in San Antonio, to hire a Quality Control Lab Manager.

Who we are

We are a dynamic recruitment and executive search agency that has evolved since our first establishment in 2012. We work with several high-profile clients, start-ups, and SMEs globally to help them source and retain top-tier talent.

The client

Global organisation operating in the Medical Diagnostic Manufacturing industry.

The Role

As a Quality Assurance Manager, you will play a pivotal role at our South Bend, Indiana site. You will lead and direct quality assurance and regulatory activities to ensure that our products meet the highest standards of quality and compliance. Plans, coordinates, and directs QA and regulatory activities, either directly or via delegates, to maintain continuous product manufacturing that aligns with the Quality Management System and regulatory standards, emphasizing organizational compliance.

Requirements\Qualifications

  • Bachelor's degree (B.A. /B.S.) from an accredited college or university in a science related field.
  • Authorized to work in the United States.
  • 5 years quality and regulatory experience in relation to medical device or In vitro diagnostics devices.
  • Minimum of two years of supervisory experience.
  • Strong knowledge of various standards and regulations such as ISO 13485, ISO 14971, the Quality System Regulation (21 CFR Part 820)
  • Knowledge of other applicable country regulatory requirements such as the EU IVDD/IVDR and the UK MDR, etc.
  • Strong Root Cause Analysis skills (5 whys, Fishbone Diagrams, etc).

Job Level: Mid-Senior Level

Job Type: Full Time

Job Summary

JOB TYPE

Full Time

SALARY

$107k-135k (estimate)

POST DATE

07/04/2024

EXPIRATION DATE

08/02/2024

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The following is the career advancement route for Quality Assurance Manager positions, which can be used as a reference in future career path planning. As a Quality Assurance Manager, it can be promoted into senior positions as a Quality Assurance Senior Manager that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Assurance Manager. You can explore the career advancement for a Quality Assurance Manager below and select your interested title to get hiring information.

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