Purpose
The Quality Control Manager ensures that all PortableConnect devices and components meet ROMTech’s quality standards, regulatory requirements, and patient ready criteria. This role oversees all inspection activities, incoming, in process, repair/upgrade, and final release, and ensures consistent, compliant execution across the production lifecycle.
The Quality Control Manager provides strategic leadership, manages inspection teams, ensures audit readiness, and drives continuous improvement to reduce defects, eliminate escapes, and support efficient, compliant production.
Key Results and Metrics
Key Result: Ensures the quality, consistency, and compliance of all ROMTech products across the device lifecycle.
Key Performance Metrics:
- Inspection throughput and on time completion
- First Pass Yield
- Defect and escape rates
- Nonconformance closure timeliness
- CAPA effectiveness
- Audit outcomes and readiness
- Rework rates
- On time and compliant device release
Winning Attitude and Mindset
The Quality Control Manager leads with ownership, integrity, and a patient first mindset. They reinforce disciplined, standardized execution while enabling efficient operations. They expect issues to be escalated early, promote root cause thinking, and cultivate a culture where quality is proactively protected, not inspected in after the fact.
Core Responsibilities
1. Quality Oversight & Leadership
- Lead, coach, and develop the Quality Inspector team.
- Manage staffing, scheduling, and resource allocation.
- Ensure inspection consistency and adherence to standard work.
- Conduct performance reviews and support employee development.
- Uphold a positive, compliant, and high accountability culture.
2. Inspection Program Management
- Oversee incoming, in process, repair/upgrade, and final inspection operations.
- Ensure inspection coverage aligns with production demand and risk.
- Maintain inspection standards, sampling plans, and risk based approaches.
- Serve as approver for device release when required.
- Address daily line support issues and drive resolution.
3. Compliance & Quality Systems
- Ensure compliance with FDA QSR (21 CFR 820), ISO 13485, and internal QMS expectations.
- Maintain inspection procedures, work instructions, and documentation.
- Support internal, external, and regulatory audits; lead corrective actions.
- Partner with Regulatory and Quality Assurance on compliance strategy.
4. Nonconformance & CAPA
- Oversee identification and documentation of nonconforming product.
- Lead or support root cause investigations.
- Drive implementation and verification of corrective/preventive actions.
- Ensure containment and prevent recurrence of defects and quality escapes.
5. Cross Functional Collaboration
- Collaborate with Production, Engineering, Supply Chain, and Repair teams to resolve issues.
- Provide quality input for process changes, design changes, and NPI.
- Support supplier quality efforts and feedback loops related to incoming parts.
- Escalate systemic risks to leadership with data driven analysis.
6. Continuous Improvement
- Drive initiatives to improve yield, reduce rework, and reduce inspection burden through improved processes.
- Promote automation, standardization, and error proofing solutions.
- Use data to prioritize and implement quality improvements.
- Implement risk based inspection strategies and sampling methods.
7. Documentation & Reporting
- Ensure inspection data is accurate, complete, and traceable.
- Maintain device history record (DHR) integrity for inspections.
- Provide dashboards and reporting on key quality indicators.
- Communicate quality performance and risks to leadership regularly.
Patient Impact
Through strong leadership and rigorous oversight, the Quality Control Manager ensures that every PortableConnect device meets the highest safety, reliability, and performance standards before reaching a patient. Their work minimizes delays, eliminates defects, and reinforces trust in ROMTech’s technology, directly supporting safe, effective recovery experiences.