Sustaining Quality Director

Medline; Northfield Township, Northern (IL, KY); Hybrid; USD 177,000 - 266,000; Full time

Job summary

Medline is seeking a Sustaining Quality Director to lead the Sustaining Quality organization, ensuring quality and compliance for commercial products and QMS processes. You will translate priorities into functional plans, guide remediation and lifecycle quality initiatives, and partner across Regulatory Affairs, R&D, Manufacturing, and Operations to drive alignment.

The role requires strategic leadership, risk-based decision making, and the ability to manage audits and CAPA programs, with

Qualifications

• Depth of knowledge of 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, MDR and related standards.
• Ability to analyze data to identify issues, trends, or exceptions and drive improvement.
• Experience leading complex, cross-functional remediation programs with deadlines.

Responsibilities

• Develop and implement strategy, operating model, and governance for Sustaining Quality.
• Lead cross-functional remediation and product lifecycle quality programs.
• Establish risk-based portfolio management and execution controls.
• Identify systemic process gaps and implement sustainable improvements.
• Coordinate with senior leadership and diverse functions to drive alignment and decisions.
• Oversee audit readiness and ensure supporting records and evidence are complete and compliant.

Skills

Regulatory standards knowledge

Data analysis & reporting

Cross-functional leadership

Executive communication

Excel proficiency

Education

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

Job description

## Sustaining Quality DirectorApply: Hybrid: Northfield, Illinois: Full time: Posted Today: R2619035**Job Summary**Responsible for providing leadership and direction to the Sustaining Quality organization to ensure quality and compliance for commercial products and associated Quality Management System processes. Develop strategy, translate priorities into functional plans, and guide execution of long-term remediation, product lifecycle quality, and systemic improvement goals.**Job Description**MAJOR RESPONSIBILITIES * Develop and implement the strategy, operating model, priorities, and governance for Sustaining Quality in alignment with Quality objectives, regulatory commitments, and business needs.* Lead complex, cross-functional remediation and product lifecycle quality programs.* Establish risk-based portfolio management and execution controls to prioritize work, assign resources, monitor milestones, manage dependencies, and escalate patient safety, compliance, product availability, and business continuity risks.* Identify systemic process, governance, and ownership gaps revealed through remediation, CAPAs, complaints, risk assessments, field actions, and audits; partner with process owners to implement sustainable improvements and prevent recurrence.* Act as liaison with senior leadership, Divisional Quality, Corporate Quality, Regulatory Affairs, Research and Development, Product Management, Manufacturing, Operations, and other functions to drive alignment, decisions, and execution.* Oversee inspection and audit readiness for assigned programs and ensure supporting records and objective evidence are complete, accurate, traceable, and compliant with applicable requirements.* Develop and maintain performance measures and executive reporting for remediation progress, quality-system backlog, CAPA effectiveness, risk, resource capacity, and program performance.* Lead, develop, and allocate internal and contract resources to support changing regulatory, technical, and business priorities while building sustainable organizational capability.Management responsibilities include: * Typically manages through multiple Managers. Provides leadership and management to one or more major departments of an operating unit or to a department that has system-wide accountability.* Strategic, tactical, and operational planning for the function or department extending 12 months or longer.* Direct budgetary responsibility for one or more departments, functions, or major projects/programs.* Interpret and execute organizational policies and recommend new policies or modifications to existing policies.* Hiring staff, recommending pay increases, performing performance reviews, training and developing staff, estimating personnel needs, assigning work, meeting completion dates, and ensuring consistent application of organizational policies.MINIMUM JOB REQUIREMENTS Education Bachelor’s degree in Engineering, Science, Quality, Regulatory Affairs, or a related technical field. Work Experience * At least 7 years of experience in medical device, pharmaceutical, drug combination product, or another regulated industry, including experience with quality systems, design controls, risk management, CAPA, remediation, or post-market quality activities.* At least 4 years of management experience.Knowledge / Skills / Abilities * Depth of technical knowledge of relevant standards and regulations, including 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, and MDR.* Proficiency in analyzing and reporting data to identify issues, trends, or exceptions, drive improvement, and support risk-based decision-making.* Demonstrated ability to lead complex, cross-functional programs; control concurrent projects and competing priorities; and meet critical deadlines.* Demonstrated ability to identify systemic issues, translate requirements into sustainable processes, and influence decisions across organizational boundaries.* Advanced communication skills with the ability to present complex quality, regulatory, and business matters to senior and executive leadership.* Advanced proficiency in Microsoft Excel and other tools used for data analysis, reporting, and program management.Position requires travel up to 30% of the time for business purposes within state, out of state, and/or internationally. PREFERRED JOB REQUIREMENTS Work Experience * At least 6 years of managerial experience preferred.* At least 8 years of related experience in the Medical Device, Pharmaceutical, Drug Combination Product, or other regulated healthcare product industry preferred.* Experience establishing or leading an enterprise or cross-divisional quality function, remediation program, or operating model preferred.* Experience leading a blended workforce of employees, contractors, and technical subject-matter experts preferred.Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.The anticipated salary range for this position:$177,000.00 - $266,000.00 AnnualThe actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.