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 Annual
The 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.
Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here.
We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.
Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.