On-site Senior Life Sciences Quality Leader | ISO 13485

Polyzen, Inc.; Winston-Salem (NC); On-site; USD 130,000 - 180,000; Full time

Benefits offered by this job

Generous Paid Time Off

Annual Bonus

401(k) with excellent company match

Health Insurance with multiple plans

Paid Short Term and Long Term Disable

Job summary

Charter Medical, part of the Solesis family, is seeking a Life Sciences Quality Leader on-site in Winston-Salem, NC. You will head Quality Operations including document control, QA, quality engineering, and all QMS requirements, ensuring regulatory compliance and successful product releases.

You will lead audits, CAPAs, deviations and investigations, and drive continuous improvement with cross-functional teams. Requires a BS in Engineering and 5–8 years in life sciences/medical devices.

Qualifications

• Bachelor’s degree in an Engineering discipline.
• 5–8 years in Life Sciences, Single-Use Technologies & Medical Devices.
• 2–3 years of leading a team or managing direct reports.
• Knowledge of regulatory requirements and quality-system frameworks.
• Demonstrated expertise with ISO 13485 and 21 CFR 820/cGMPs.

Responsibilities

• Lead Quality Operations including QA, Document Control, and QMS.
• Oversee internal/external audits and regulatory reporting and compliance.
• Maintain ISO 13485 compliance and product release processes.
• Lead investigations, CAPAs, NCRs, deviations with root-cause analysis.
• Coordinate cross-functional quality reviews and improvements.
• Monitor quality metrics and drive continuous improvement initiatives.

Skills

Quality leadership

Regulatory knowledge

ISO 13485

21 CFR 820

cGMP

Strong communication

Problem solving

Education

Bachelor’s degree in Engineering

Job description

Charter Medical, part of the Solesis family, is seeking a Life Sciences Quality Leader on-site in Winston-Salem, NC. You will head Quality Operations including document control, QA, quality engineering, and all QMS requirements, ensuring regulatory compliance and successful product releases.

You will lead audits, CAPAs, deviations and investigations, and drive continuous improvement with cross-functional teams. Requires a BS in Engineering and 5–8 years in life sciences/medical devices.