Medline Industries

Medline Industries

Director Quality Assurance, Manufacturing

Waukegan, Illinois · Director

Sponsorship not specified$154k-$231kDetected 4 hours ago
ComplianceExcelPerformance ManagementGMPFDA RegulatoryMedical DevicesLeadership

About the role

  • 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.
  • 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.

Responsibilities

  • 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.
  • Typically, manages through multiple Managers. Provides leadership and management to site QA/QC teams.
  • Interpret and execute policies for departments/projects and develops;
  • Recommend and implement new policies or modifications to existing policies;
  • 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.

Requirements

  • Typically requires a Bachelor's degree in Engineering, Science, or Technical Field.
  • Depth of technical knowledge of relevant standards and regulations (21CFR 820, 21 CFR 210/211, 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.
  • 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 (21CFR 820, 21CFR 210/211, ISO 13485, ISO 14971, MDSAP, and MDR).
  • Advanced level skill in Microsoft Excel (for example: using AVERAGE function, merging and centering cells, printing centered page and/or creating a pivot table).

Nice to have

  • At least 6 years of managerial experience preferred.
  • We're dedicated to creating a Medline where everyone feels they belong and can grow their career.
  • Explore our Belonging page here.
  • Medline Industries, LP is an equal opportunity employer.

Skills

  • using AVERAGE function, merging and centering cells, printing centered page and/or creating a pivot table).

Compensation

  • $154,000.00 - $231,000.00 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.

Benefits

  • 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 a more comprehensive list of our benefits please click here.
Apply directly at Medline Industries →Create a free account for alerts like thisView Medline Industries immigration profile

This listing is sourced directly from Medline Industries's careers page and normalized into a canonical job model.