Manager QA

Medline Industries, LP; Northfield (MN); On-site; USD 116,000 - 174,000; Full time

Job summary

Medline Industries, LP is seeking a quality/regulatory professional to manage the quality and compliance for assigned product lines. You will adapt plans to address resource and operational challenges across departments and ensure alignment with regulatory requirements.

The role emphasizes cross-functional collaboration with divisions, suppliers, manufacturing and operations, managing complaints, and driving continuous improvements in design, testing, and process validation to deliver safe,

Qualifications

• Bachelor’s degree in Engineering, Science, or Technical Field.
• Minimum 4 years in design/operation of medical device or drug combination product platforms with QSR/GMP/ISO exposure.
• Experience with regulatory standards (21CFR 820, ISO 13485, ISO 14971, MDR, MDSAP).
• Strong data analysis and trend identification abilities.
• Ability to coordinate multiple projects and meet deadlines; travel up to 25%.

Responsibilities

• Ensure quality and regulatory compliance for product life cycle and regions of distribution.
• Liaise with divisions, suppliers, manufacturing to ensure quality and customer satisfaction.
• Manage complaints and develop solutions from investigations.
• Identify and drive continuous improvement projects; assist in product evaluation from QA/regulatory standpoint.
• Assist planning of design, testing, inspection, and process validations.

Skills

QA & regulatory

Data analysis

Project management

Excel proficiency

Travel readiness

Education

Bachelor’s degree in Engineering/Science/Technical Field

Job description

Job Summary

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.
• Acts as a liaison with the Divisions, Suppliers, Manufacturing, and/or Operations to ensure quality products and customer satisfaction.
• Manage complaints and develop new approaches to solve problems identified during the investigation process.
• Identify and manage the execution of continuous improvement projects. Assist the division in product evaluation from a quality assurance and regulatory compliance standpoint.
• Assist in the planning of the design, testing, inspection, and process validations to assure quality products or components.
• Ensure all quality issues are resolved to customer satisfaction, in a timely manner. Resolve issues relating to product or production quality by interfacing with internal and external customers.

Management responsibilities include

• Typically oversees professional employees/teams OR typically manages non-professional employees through Supervisors in manufacturing, distribution or office environments
• Day-to-day operations of a group of employees;
• 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.
• Provide general guidelines and parameters for staff functioning.
• 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.

Requirements

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).

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).
• Position requires travel up to 25% of the time for business purposes (within state, out of state and/or internationally).

Preferred Requirements

Work Experience

• At least 2 years of supervisory/managerial experience.
• Experience in Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products Industries.

Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.

Salary

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.

Benefits

• health insurance
• life and disability
• 401(k) contributions
• paid time off
• etc.
• 401(k) contributions, paid time off for employees working less than 30 hours per week
• access to the Employee Assistance Program
• Employee Resource Groups
• Employee Service Corp

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.

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.