Job Description
Job Description
Quality Assurance Manager
Compensation: $110,000 Base Salary
Location: Dallas, TX (Hybrid)
Overview
We are seeking a hands-on Quality Assurance Manager to lead and continuously improve the Quality Management System (QMS) within a regulated manufacturing environment. This role is ideal for an independent, resourceful professional who thrives with ownership, takes initiative, and can effectively lead quality system activities without requiring close supervision.
The Quality Assurance Manager will oversee quality systems, CAPA, audits, risk management, regulatory compliance, complaint handling, and post-market surveillance activities. This position manages two direct reports and plays a critical role in supporting internal and external audits while driving continuous improvement throughout the organization.
What You'll Do:
Quality Systems & Compliance
- Own and maintain the Quality Management System (QMS).
- Lead CAPA processes, root cause investigations, and corrective actions.
- Manage document control, change control, training records, and quality documentation.
- Oversee Device Master Records (DMR), Design History Files (DHF), and related quality records.
- Develop and track quality metrics and KPIs.
- Support validation activities for processes, equipment, and software.
Audit & Regulatory Leadership
- Serve as the primary point of contact during internal and external audits.
- Lead audit preparation, facilitate auditor requests, and coordinate responses across functions.
- Ensure compliance with FDA, ISO 13485, and other applicable regulatory requirements.
- Drive timely resolution of audit findings and corrective actions.
Complaint Handling & Post-Market Surveillance
- Own complaint handling activities from intake through closure.
- Support Medical Device Reporting (MDR) decisions and submissions.
- Analyze complaint trends and incorporate findings into CAPA and risk management processes.
- Support field actions, recalls, and post-market surveillance initiatives.
Risk Management & Supplier Quality
- Lead risk management activities aligned with ISO 14971 principles.
- Partner with suppliers, engineering, procurement, and quality teams to assess and mitigate quality risks.
- Support supplier qualification, monitoring, and audit activities.
Leadership & Continuous Improvement
- Manage and develop a team of two direct reports.
- Lead quality training initiatives and maintain compliance-related training programs.
- Drive continuous improvement efforts using Lean, Six Sigma, and other quality methodologies.
- Foster a culture of accountability, quality, and operational excellence.
Required Qualifications
- Bachelor's degree in Engineering, Quality, Life Sciences, or related field, or equivalent experience.
- 5+ years of experience in Quality Systems, Quality Assurance, Regulatory Compliance, or a related quality function within a regulated manufacturing environment.
- 2+ years of leadership or supervisory experience.
- Strong background in:
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- Quality Management Systems (QMS)
- CAPA
- Risk Management
- Regulatory Compliance
- Internal and External Audits
- Complaint Handling
- Document Control
- Experience working with electronic QMS or PLM systems.
- Strong communication, organizational, and problem-solving skills.
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Preferred Qualifications
- Certified Quality Auditor (CQA), ASQ, Six Sigma, or similar certification.
- Experience supporting FDA-regulated products and ISO-compliant environments.
- Experience with supplier quality programs and regulatory inspections.
Preferred Systems Experience
- Arena PLM/QMS
- Oracle NetSuite
- Microsoft Office Suite
Ideal Candidate Profile
- Self-starter who takes ownership and drives results.
- Comfortable working independently with minimal management oversight.
- Strong audit-facing presence and confidence interacting with auditors.
- Motivated to improve processes rather than simply maintain them.
- Open to candidates from medical device, pharmaceutical, aerospace, automotive, manufacturing, or other regulated industries.
Team Structure
- 2 direct reports currently in place.
- Planned team growth in the future.
Why This Opportunity?
This is a highly visible leadership opportunity for someone who enjoys owning critical quality functions, leading audits, improving systems, and helping build a scalable quality organization while working in a collaborative and fast-paced environment.