RA/QA Manager
PAPR / NIOSH
Respiratory Protection Systems 7201 Iron Horse Boulevard, North Richland Hills, TX 76180 $80,000- $120,000 a year
- Full-time $80,000
- $120,000 a year
- Full-time Prestige Ameritech is seeking an experienced Regulatory Affairs / Quality professional to lead and support regulatory and quality activities for our expanding Powered Air Purifying Respirator (PAPR) product line.
This is NOT a general quality role. We are specifically seeking candidates with experience in PAPR systems, NIOSH-certified products, and TC approval/submission processes.
REQUIRED EXPERIENCE
PAPR and/or respiratory protection product experience Familiarity with
NIOSH TC
approval submissions and maintenance Experience supporting regulated product quality systems Experience with change control, documentation, and product configuration management Ability to work cross-functionally with operations, manufacturing, engineering, and leadership teams
STRONGLY PREFERRED
Prior experience with: Honeywell 3M MSA Safety Bullard Other respiratory protection or industrial safety manufacturers Familiarity with: NIOSH respiratory approvals TC numbers and configuration management FDA and/or
ISO 13485
quality systems CAPA and validation activities Product labeling and regulatory documentation
POSITION SUMMARY
This role will support the continued growth and regulatory compliance of a domestic respiratory protection manufacturing operation. The position requires a hands-on individual comfortable operating within a manufacturing environment while supporting quality systems, regulatory submissions, product compliance, and ongoing NIOSH requirements. Candidates without respiratory protection or NIOSH-related experience are unlikely to be a fit for this role.
Pay:
$80,000.00
00 per year
Benefits:
Health insurance Application Question(s): Do you have direct experience with
NIOSH TC
approval submissions or maintenance? Please briefly describe your experience with
NIOSH TC
approvals, or PAPR systems. Do you have quality/engineering/manufacturing experience with PAPR products?
Experience:
PAPR/NIOSH
1 year (Required)
Work Location:
In person