Manager Quality Assurance, Audit Sterilization/Micro

Job Summary

This role needs to be based in commuting distance to our corporate headquarters in Northfield, IL. Relocation assistance may be available for the right candidate. This position requires travel up to 40% of the time for business purposes (within state, out of state and/or internationally
Responsible for managing the quality and compliance for applicable products and processes for assigned department(s). Adapt departmental plans and priorities to address resource and operational challenges.

Job Description

Responsibilities:

• Ensure quality and regulatory compliance with applicable regulations (ex. QSR, GMP,ISO) pertaining to the applicable life cycle and regions of distribution for the product.
• Leads Internal and Supplier Audits for Medline, ensuring internal procedures and FDA/ISO requirements are met for Medical device/drug products. Audit a broad, global supplier base against FDA regulations, ISO standards, and other applicable global regulatory requirements across the full spectrum of Medline products including sterile products, APIs, raw materials, medical devices, pharmaceuticals, biologics, cosmetics, medical foods, and dietary supplements, as well as contract sterilizers and laboratories. Perform internal audits of Medline divisions and manufacturing sites. Lead complex, critical, supplier regulatory projects involving cross-functional teams.
• Ensures CAPA and SCAR documentation from suppliers and internal partners are received on time per procedures and are adequate. Lead and Mentor auditors on the internal audit team and conduct trainings for the team as required on new updated regulations.
• Identify and manage the execution of continuous improvement projects. Assist the division in product evaluation from a quality assurance and regulatory compliance standpoint.
• Maintain professional relationships with Medline division QA and suppliers, while enforcing industry regulatory requirements based on product classifications and audit agenda. Attend Audit escalation meetings and oversee/review audit observations for applicability and merit

Management responsibilities include:

• Oversee Internal audit team of auditors, maintain audit schedule and maintain audit team metrics.
• Support Day-to-day operations for Audit team.
• May have limited budgetary responsibility and usually contributes to budgetary impact;
• Interpret and execute policies for departments/projects and develops.
• Recommend and implement new policies or modifications to existing policies (update procedures for internal audit, supplier quality).
• Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies.

Qualifications

Education

• Bachelor’s degree in Engineering, Science, or Technical Field.

Work Experience

• At least 4 years of experience related to the design/operation of medical device or drug combination product platforms, design controls, risk management, including working in compliance with QSR/GMP/ISO requirements or other regulated industries (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR).
• Experience applying knowledge of process validation, method validation, CAPA/SCAR and supplier/vendor governance per FDA requirements.
• Experience leading senior level employees, and providing clear direction for department goals. Minimum 4 years or more experience with conducting Audits Internal/external, accredited auditor a plus.

Knowledge/Skills/Abilities

• Broad technical knowledge of relevant standards and regulations (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR etc.)
• Proficiency in analyzing and reporting data in order to identify issues, trends, or exceptions to drive improvement of results and find solutions.
• Demonstrated ability to control and coordinate concurrent projects, competing priorities and critical deadlines.
• Advanced level skill in Microsoft Excel (for example: using AVERAGE function, merging and centering cells, printing centered page and/or creating apivot table).
• Detail-oriented, with excellent oral and written communication skills.
• Ability to listen and process all relevant details, understanding and prioritizing their importance and drawing clear and concise conclusions.
• Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives and determining when escalation of issues is necessary.
• Experience controlling and coordinating concurrent projects, competing priorities and critical deadlines.
• Broad technical knowledge of relevant standards and regulations (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR etc.)
• Proficiency in analyzing and reporting data in order to identify issues, trends, or exceptions to drive improvement of results and find solutions.
• Demonstrated ability to control and coordinate concurrent projects, competing priorities and critical deadlines.
• Advanced level skill in Microsoft office products, and smartsheets.
• Position requires travel up to 40% of the time for business purposes (within state, out of state and/or internationally).

Preferred Qualifications:

• At least 4 years of supervisory/managerial experience in Quality or Regulatory Affairs teams.
• Experience in Auditing for Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products Industries with a focus on Sterilization or Microbiology requirements for Med Device/Drug.

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:

$116,000.00 - $174,000.00 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.