Director of Sustaining Quality & Compliance

Medline Industries, LP; Northfield (MN); On-site; USD 177,000 - 266,000; Full time

Benefits offered by this job

Health insurance

Life and disability

401(k) contributions

Paid time off

Job summary

Medline Industries, LP in Minnesota seeks a Senior Director to lead Sustaining Quality, directing quality and compliance for commercial products and QMS processes, translating priorities into strategic plans and guiding long-term remediation and product lifecycle quality programs.

You will manage cross-functional remediations, risk-based portfolio controls, and executive reporting while building organizational capability. Travel up to 30% and a competitive rewards package included.

Qualifications

• Bachelor’s degree in Engineering, Science, Quality, Regulatory Affairs, or related field.
• 7+ years of experience in medical device, pharmaceutical, drug products, or other regulated industry.
• 4+ years of management experience.
• Knowledge of 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, MDR.
• Strong data analysis and risk-based decision-making ability.

Responsibilities

• Develop and implement Sustaining Quality strategy aligned with regulatory commitments.
• Lead cross-functional remediation and product lifecycle quality programs.
• Establish risk-based portfolio management and execution controls.
• Partner with process owners to implement sustainable improvements and CAPA.
• Oversee audits, records, and executive reporting on remediation progress and backlog.

Skills

Regulatory knowledge

Quality systems

Cross-functional leadership

Data analysis

Risk management

Microsoft Excel

Communication skills

Travel readiness

Education

Bachelor's degree in Engineering, Science, Quality, Regulatory Affairs, or related field

Tools

Microsoft Excel

Job description

Medline Industries, LP in Minnesota seeks a Senior Director to lead Sustaining Quality, directing quality and compliance for commercial products and QMS processes, translating priorities into strategic plans and guiding long-term remediation and product lifecycle quality programs.

You will manage cross-functional remediations, risk-based portfolio controls, and executive reporting while building organizational capability. Travel up to 30% and a competitive rewards package included.