Senior Quality Assurance Leader – Medical Devices

ARCH; Olive Branch (MS); On-site; USD 110,000 - 150,000; Full time

Job summary

ARCH Global Precision is seeking a Senior Quality Assurance Manager to lead the Quality Assurance function and maintain a robust QMS aligned with regulatory standards. This role provides strategic leadership for quality systems, regulatory compliance, audits, risk management, and continuous improvement in a regulated manufacturing environment.

Key responsibilities include leading the QMS, serving as the primary quality leader for audits, managing CAPA and NCR processes, and ensuring training and

Qualifications

• Bachelor’s degree is required, preferably in a scientific discipline.
• 5–10 years hands-on experience with quality systems supporting medical device manufacturing.
• 3–5 years management experience.
• In-depth knowledge of FDA 21 CFR Part 820; Quality System Regulation.
• Familiar with ISO 13485 Medical Device Directive.
• ASQC and/or ASQE certification is a plus.
• Proficient with MS Office applications.
• Six Sigma Black Belt or Green Belt training is a plus.

Responsibilities

• Lead, maintain and continuously improve the Quality Management System (QMS) in alignment with regulatory requirements.
• Serve as primary quality leader for internal, customer, and regulatory audits and inspections.
• Oversee CAPA, NCR, complaint handling, and escalation processes with timely investigation and corrective actions.
• Ensure manufacturing and inspection processes are compliant and effectively executed.
• Drive risk-based decision making across quality systems, supplier quality, and process improvement.
• Monitor quality metrics, trends, and KPIs to identify issues and support management review.
• Partner with Operations, Engineering and Manufacturing to define and maintain product quality requirements.
• Manage internal and supplier audits and external regulatory audits; handle responses and closures.
• Ensure DHRs and quality records are complete and documented per document control.

Skills

Leadership

Regulatory knowledge

Quality systems

Audits

Analytical thinking

Problem-solving

Decision-making

Communication

Education

Bachelor's degree in a scientific discipline

ASQ/ASQE certification

Tools

MS Office

Job description

ARCH Global Precision is seeking a Senior Quality Assurance Manager to lead the Quality Assurance function and maintain a robust QMS aligned with regulatory standards. This role provides strategic leadership for quality systems, regulatory compliance, audits, risk management, and continuous improvement in a regulated manufacturing environment.

Key responsibilities include leading the QMS, serving as the primary quality leader for audits, managing CAPA and NCR processes, and ensuring training and