Director Quality Assurance, Manufacturing

Job Summary

Responsible for providing leadership and direction to Quality team(s) to ensure quality and compliance for the applicable products and processes for assigned department(s) at the manufacturing site. Develop strategy, translate into functional plans and guide execution of long-term goals.

• Management Representative for the site to ensure quality and regulatory compliance with applicable regulations (e.g., QSR, PQS, GMP, ISO, ICH) pertaining to the product's applicable life cycle and regions of distribution.
• Partner with Plant Operations to ensure optimal collaborative, effective relationships and drive continuous improvement.
• Develop and implement a strategy for the Quality department(s) based on the Quarterly Management Review.
• Ensure the Manufacturing site readiness for internal audits, external regulatory audits, and customer visits.
• Act as liaison with Senior Leadership of Divisions, Suppliers, Manufacturing, and/or Operations to ensure quality products, on time delivery, and customer satisfaction.
• Oversee procedures for inspection and ensure test methods are followed for incoming, in-process, and finished product release to ensure product is in alignment with applicable regulations.
• Oversee QSR/QMS/PQS for assigned department(s) and ensure compliance as measured by FDA/ISO/internal audits.
• Manage through multiple managers, providing leadership and management to site QA/QC teams.
• Strategic, tactical and operational planning (12+ months) for the function or department.
• Direct budgetary responsibility for one or more departments, functions or major projects/programs.
• Interpret and execute policies for departments/projects and develop and recommend new policies or modifications to existing policies.
• Hire staff, recommend pay increases, perform performance reviews, train and develop staff, estimate personnel needs, assign work and meet completion dates, interpret and ensure consistent application of organizational policies.

• Bachelor’s degree in Engineering, Science, or Technical Field.
• At least 7 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/PQS/ICH requirements or other regulated industries (21
  
  CFR 820, 21
  
  CFR 210/211, ISO 13485, ISO 14971, MDSAP, and MDR).
• Depth of technical knowledge of relevant standards and regulations (e.g., 21
  
  CFR 820, 21
  
  CFR 210/211, ISO 13485, ISO 14971, MDSAP, MDR).
• Proficiency in analyzing and reporting data 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 (e.g., using AVERAGE function, merging and centering cells, printing centered page and/or creating a pivot table).

• At least 6 years of managerial experience.
• At least 8 years of related experience in Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products industries.

The anticipated salary range for this position: $ - $ annually. 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.

Benefits include health insurance, life and disability, 401(k) contributions, paid time off, employee assistance program, employee resource groups and employee service corp. For employees working 30 or more hours per week on average, benefits extend to additional programs. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions and paid time off.

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.