Intertwined

QC Process Control Manager (re-lo to Allentown PA area)

Full Time
Raleigh, NC, USA
Description

The Denzel Group, an award-winning search firm, has been chosen to work with a global industry leader on their quest for a talented QC Process Control Manager. In this role, you will oversee a team of about 20 quality inspectors, and have 2 directly reporting Supervisors. 


This is NOT a QC analytical team. This team conducts visual and functional testing of medical device products, including tests such as occlusion, pressure, pull, dimensional, extension tests.


Responsibilities

  • Team management, including staffing, training, competencies, scheduling, budgeting, etc.

  • Guide the team conducting visual and physical inspections of products and materials. 

  • Manage quality control activities.

  • Ensure products meet quality standards, and develops corrective actions.

  • Develop, implement and assesses processes and policies designed to test products and services. 

  • Continuous improvement for testing processes. 

  • Enforce regulatory compliance. 


Requirements
  • BS degree, at minimum.

  • 5+ years’ compliance / quality experience in a GMP manufacturing environment, including experience with root cause analysis investigations regarding product non-conformances and deviations.

  • Leadership experience in a QC environment with direct reports including staffing, competencies, and performance reviews.

  • Ability to work 10-12 hour days on 1st shift, and also accommodate occasional calls for 2nd and 3rd shift activity (about 1 or 2 times/week).

Preferred

  • QC experience conducing Medical Device visual and functional testing such as occlusion, pressure, pull, dimensional, and extension tests.

Applicable Compliance Experience

1.Medical Device: CFR 820, ISO 13485 (BEST)

2.Pharma: CFR 210, 211 (2nd best)

3.Pharma: biologics (okay)

4.GMP food/beverage: (least applicable)



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


#IND1


QC, quality control, root cause, supervisor, manager, lead, cfr, 820, 210, 211, ISO 13485, medical device

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