QC Process Control Manager (re-lo to Allentown PA area)
Baltimore, MD, USA
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.
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.
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).
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 email@example.com
QC, quality control, root cause, supervisor, manager, lead, cfr, 820, 210, 211, ISO 13485, medical device