Asst Mgr QA

Medline Industries, Inc.; Northfield (MN); On-site; USD 101,000 - 152,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP is seeking a Quality Engineer to manage quality and regulatory compliance for assigned products and processes. You will support the division with compliant design controls, risk management, and documentation across lifecycle stages.

The role involves cross-functional collaboration, leading investigations, and driving continuous improvement projects. Travel up to 25% is required, with a competitive salary range and benefits.

Qualifications

• Bachelor’s degree in Engineering, Science, Math, or related field is usually required, or equivalent experience.
• At least 3 years Quality Engineering experience.
• Knowledge of quality assurance standards (e.g. 21 CFR 820, ISO13485).
• Experience analyzing data to identify issues and drive improvements.
• Experience leading cross-functional teams and managing concurrent projects.
• Willingness to travel up to 25% of the time.

Responsibilities

• Ensure quality and regulatory compliance with applicable regulations for the product lifecycle and distribution regions.
• Build and maintain product documentation (Device Master Records, Design Controls, Risk Management, CE Technical Files).
• Collaborate with Regulatory Groups and Suppliers for 510K submissions and related documents.
• Serve as liaison with Divisions, Suppliers, Manufacturing, and Operations to ensure quality and customer satisfaction.
• Lead investigations of non-conformances and CAPA development with suppliers as needed.
• Identify and manage continuous improvement projects across processes and products.
• Assist in planning design, inspection, process validation, and testing coordination to ensure quality.
• Ensure timely resolution of quality issues to customer satisfaction.

Skills

Quality engineering

Regulatory compliance

Data analysis

Project coordination

Team leadership

MS Office

Education

Bachelor’s degree in Engineering, Science, Math, or related field

Tools

MS Office (Excel, PowerPoint)

Job description

Job Summary

Responsible for managing the quality and compliance for applicable products and processes for assigned area(s). Assume responsibility for a subset of individual projects that support the division and/or manufacturing area, compliance, new product development per the needs of the team.

Job Description

MAJOR 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.
• Responsible for building and maintaining appropriate product documentation (e.g. Device Master Records, Design Controls, Risk Management, and CE Technical Files) in compliance with applicable regulations.
• Work with Regulatory Groups and Suppliers to produce 510K submissions, letters to file, etc., as required.
• Acts as a liaison with the Divisions, Suppliers, Manufacturing, and/or Operations to ensure quality products and customer satisfaction.
• Help in complaint trend investigations and develop new approaches to solve problems identified during the investigation process.
• Identify, implement 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, inspection, process validations, and coordinate testing 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.
• Lead investigations of product and process non-conformances and out-of-specification results and collaborate with supplier representatives, as needed, to develop effective corrective and preventive actions (CAPA, SCAR).

Management responsibilities:

• Typically manages teams of 2-3 employees, depending on the workload and the required level of involvement with direct reports. Teams may include QCs, QA/Sr QA Technicians, AQS, AQE, QS, and QE;
• Oversees day-to-day operations of a group of employees.
• May have limited budgetary responsibility and usually contributes to budgetary impact.
• Interprets and executes policies for departments/projects and develops them.
• Recommends and implements new policies or modifications to existing policies.
• Provides general guidelines and parameters for staff functioning.
• Plays a key role in hiring staff, recommending pay increases, conducting performance reviews, training and developing staff, estimating personnel needs, assigning work, meeting completion dates, and interpreting and ensuring consistent application of organizational policies.

MINIMUM JOB REQUIREMENTS:

Education

• A Bachelor’s degree in Engineering, Science, Math, or a related field is usually required, or equivalent experience.

Work Experience

• At least 3 years Quality Engineering experience.

Knowledge / Skills / Abilities

• Working knowledge of government and industry quality assurance codes and standards (e.g. 21 CFR 820, ISO13485).
• Experience analyzing and reporting data in order to identify issues, trends, or exceptions to drive improvement of results and find solutions.
• Experience controlling and coordinating concurrent projects, competing priorities and critical deadlines.
• Experience leading teams to accomplish cross-functional goals.
• Experience using time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects.
• Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook); including intermediate skill Level in Microsoft Excel (for example: conditional formatting, tables, formulas, charting).
• Position requires travel up to 25% of the time for business purposes (within state, out of state and/or internationally).

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:

$101,000.00 - $152,000.00 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.