Dir, QA (Product Quality)

Medline Industries, Inc.; Northfield (MN); On-site; USD 154,000 - 231,000; Full time

Benefits offered by this job

Health insurance

Life and disability insurance

401(k) contributions

Paid time off

Employee Assistance Program

Job summary

Medline Industries, LP seeks a senior Quality leader to provide direction for Quality teams, ensuring compliance with regulatory standards for assigned products and processes. You will translate strategy into concrete plans and guide long-term execution.

The role involves directing QA programs, collaborating with suppliers and product managers, and managing multiple departments with a focus on quality, on-time delivery, and customer satisfaction.

Qualifications

• Bachelor’s degree in Engineering, Science, or Technical Field.
• 7+ years in medical device or drug product platforms with design controls and regulatory compliance.
• 4+ years of management experience.
• Deep knowledge of 21 CFR 820, ISO 13485, ISO 14971, MDSAP, MDR.
• Strong data analysis and reporting to drive improvements.
• Excel proficiency including pivot tables and data analysis.

Responsibilities

• Direct development of product specifications for Medline branded products, including testing requirements and qualification methods.
• Partner with Supplier Audit and Division to optimize supplier relationships.
• Develop and implement QA strategy based on Quarterly Management Review.
• Prepare and deliver customer presentations.
• Coordinate with Senior Leadership, suppliers, manufacturing, and operations to ensure quality and on-time delivery.

Skills

Regulatory knowledge

Data analysis

Project management

Advanced Excel

Travel up to 30%

Education

Bachelor's degree in Engineering/Science/Technical Field

Job description

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). Develop strategy, translate into functional plans and guide execution of long-term goals.

Job Description

MAJOR RESPONSIBILITIES:

• Direct the development of product specifications for Medline branded products; such as the testing requirements, procedures and methods for testing, inspecting or qualifying new products and suppliers.
• Partner with Supplier Audit department and Division to determine optimal Supplier relationship.
• Develop and implement strategy for the Quality department(s) based upon Quarterly Management Review.
• Prepare and deliver Customer presentations.
• Act as liaison with Senior Leadership of Divisions, Suppliers, Manufacturing, and/or Operations to ensure quality products, on time delivery, and customer satisfaction.
• Collaborate with Suppliers, manufacturing partners and product managers in developing and implementing QA programs.
• Oversee QSR for assigned department(s) and ensure compliance as measured by FDA/ISO/internal audits.
• 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 (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 develops;
• Recommend and implement new policies or modifications to existing policies;
• 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.

MINIMUM JOB REQUIREMENTS:

Education:

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

Certification / Licensure:

• None

Work Experience:

• 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 requirements or other regulated industries (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR).
• At least 4 years of management experience.

Knowledge / Skills / Abilities:

• Depth of 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 a pivot table).
• Position requires travel up to 30% of the time for business purposes (within state, out of state and/or internationally).

PREFERRED JOB REQUIREMENTS:

Education:

• None

Certification / Licensure:

• None

Work Experience:

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

Knowledge / Skills / Abilities:

• None

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:

$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.

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.