Intertwined

QA Investigations Manager (re-lo to Allentown PA area)

Full Time
Raleigh, NC, USA
Description

*Strong re-location assistance provided!


The Denzel Group, an award-winning search firm, has been chosen to work with an industry leader in the Lehigh Valley on their quest for a talented QA Investigations Manager. This role involves managing the investigations group, but the majority of the role is hands on, performing quality engineering investigations, corrective actions, and revising policies and procedures. You will oversee a customer complaint team of 8, and another QA group of 8 supporting the business units. This role assures that internal and external investigations are thorough, and operations are compliant


Responsibilities

  • Team Management, including prioritizing projects and workload, training, hiring, terminations, performance reviews, scheduling.

  • Support regulatory inspections and customer audits.

  • Conduct surveillance trends investigations.

  • Revise policies and procedures.

  • Support quality engineering and continuous improvement.

  • Maintain a presence on the floor, and assess corrective and preventive actions.

  • Review Internal Audit (IA), Deviation, Out of Specification (OOS), and Supplier Corrective Action Notification (SCAN) responding reports.

Requirements
  • BS Degree, at minimum.

  • 6+ years’ QA investigation experience in an FDA/ISO regulated pharma and/or medical device environment.

  • 1+ years’ supervisor experience.

  • Experience with FDA Regulations, ISO Standards and Canadian Medical Device Regulations.


To apply please send your application to mschroeder@thedenzelgroup.com


#IND1


QA, quality assurance, investigation, FDA, ISO, manager, supervisor, lead, root cause, trend

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