Quality & Compliance Coach - Senior Manager
Job in
Reedsville, Mifflin County, Pennsylvania, 17084, USA
Listed on 2026-10-11
Listing for:
Insight Global
Full Time
position Listed on 2026-10-11
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager
Job Description & How to Apply Below
- Bachelor's degree in Engineering, Life Sciences, or a related technical field
- 15+ years of experience within FDA-regulated medical device manufacturing
- Extensive background in Quality Management Systems (QMS), compliance, and regulatory requirements
- Prior experience serving as a Management Representative or equivalent senior quality leadership role
- Significant experience supporting and leading FDA inspections and Notified Body audits
- Demonstrated expertise with both Front Room and Back Room audit processes
- Strong working knowledge of:
- FDA 21 CFR Part 820
- QMSR
- ISO 13485
- EU MDR
- ISO 14971
- CAPA
- PFMEA
- Root Cause Analysis
- Nonconformance Management
- Quality Notification Processes
- Proven experience driving inspection readiness and audit preparation efforts
- Strong coaching, mentoring, and team development experience
- Ability to influence leaders, SMEs, and cross-functional teams
- Experience building quality culture and organizational competency in manufacturing environments
- Serve as the onsite Quality & Compliance Coach for the manufacturing facility
- Lead quality walks and observations to reinforce quality culture and process discipline
- Coach leaders and subject matter experts on regulatory requirements, quality systems, and compliance expectations
- Prepare the site for FDA inspections, Notified Body audits, and other regulatory assessments
- Support Front Room and Back Room audit activities, including inspection strategy and execution
- Identify compliance gaps and help drive corrective actions related to Warning Letter remediation efforts
- Partner with Manufacturing, Quality, Regulatory Affairs, Engineering, and Operations teams to improve quality performance
- Evaluate quality data, audit findings, and operational trends to identify risks and improvement opportunities
- Drive sustainable QMS practices and strengthen overall system effectiveness
- Support CAPA investigations, root cause analysis, and continuous improvement initiatives
- Develop and deliver coaching, training, and mentoring programs to improve site-wide quality competency
- Promote accountability, ownership, and compliance-focused behaviors throughout the organization
- Ensure ongoing inspection readiness through proactive assessments and process improvements
- Support management review activities and quality leadership initiatives
Position Requirements
10+ Years
work experience
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