Mgr QA - Risk Management Process

Medline Industries, LP • Northfield, IL

6d • $116,000 - $174,000

About The Position

Responsible for managing quality and compliance for applicable products and processes within assigned departments. The role adapts departmental plans and priorities to address resource and operational challenges, ensures applicable regulatory compliance across product life cycles and distribution regions, and works with internal and external partners to maintain product quality and customer satisfaction.

The position manages complaints and investigations, develops approaches to solve identified problems, and identifies and executes continuous improvement projects. It assists with product evaluations from quality assurance and regulatory compliance perspectives and supports planning for design, testing, inspection, and process validation. The role also resolves product or production quality issues and ensures they are addressed promptly to customer satisfaction.

Management duties may include overseeing professional employees or teams, or managing non-professional employees through supervisors. Responsibilities include group day-to-day operations, contributing to budgetary impact, interpreting and executing departmental or project policies, recommending and implementing policy changes, providing staff guidelines, hiring and developing staff, recommending pay increases, conducting performance reviews, estimating personnel needs, assigning work, meeting deadlines, and ensuring consistent application of organizational policies. Travel up to 25% of the time may be required for business purposes, within the state, out of state, and/or internationally.

Requirements

• Bachelor’s degree in Engineering, Science, or a technical field, or relevant experience.
• At least 4 years of experience related to the design or operation of medical device or drug combination product platforms, design controls, and risk management, including work in compliance with QSR/GMP/ISO requirements or other regulated industries.
• Broad technical knowledge of relevant standards and regulations, including 21 CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR.
• Proficiency in analyzing and reporting data to identify issues, trends, or exceptions, drive improvement of results, and find solutions.
• Demonstrated ability to control and coordinate concurrent projects, competing priorities, and critical deadlines.
• Advanced Microsoft Excel skills, such as using the AVERAGE function, merging and centering cells, printing a centered page, and/or creating a pivot table.
• Ability to travel up to 25% of the time for business purposes.

Nice To Haves

• At least 2 years of supervisory or managerial experience.
• Experience in the medical device, pharmaceutical, food, cosmetic, or personal products industries.

Responsibilities

• Ensure quality and regulatory compliance with applicable regulations, such as QSR, GMP, and ISO, for applicable product life cycles and regions of distribution.
• Liaise with divisions, suppliers, manufacturing, and/or operations to ensure quality products and customer satisfaction.
• Manage complaints and develop approaches to solve problems identified during investigations.
• Identify and manage execution of continuous improvement projects.
• Assist the division in product evaluation from quality assurance and regulatory compliance perspectives.
• Assist in planning design, testing, inspection, and process validations to assure quality products or components.
• Ensure quality issues are resolved to customer satisfaction in a timely manner.
• Resolve product or production quality issues by interfacing with internal and external customers.
• Oversee professional employees or teams, or manage non-professional employees through supervisors, as applicable.
• Manage day-to-day operations of a group of employees and contribute to budgetary impact where applicable.
• Interpret and execute policies for departments or projects; develop, recommend, and implement policies or modifications to existing policies.
• Provide staff with general guidelines and parameters for their work.
• Hire staff, recommend pay increases, conduct performance reviews, and provide training and development.
• Estimate personnel needs, assign work, meet completion dates, and ensure consistent application of organizational policies.
• Travel up to 25% of the time for business purposes, including within state, out of state, and/or internationally.

Benefits

• Competitive total rewards package.
• Continuing education and training.
• Health insurance for employees working 30 or more hours per week on average.
• Life insurance for employees working 30 or more hours per week on average.
• Disability insurance for employees working 30 or more hours per week on average.
• 401(k) contributions.
• Paid time off.
• Access to the Employee Assistance Program, Employee Resource Groups, and the Employee Service Corp for employees working less than 30 hours per week.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager