Quality Manager - Capital Equipment & Furnishings

Medline Industries, LP•Chicago, IL

1d•$116,000 - $174,000•Onsite

About The Position

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. This role ensures quality and regulatory compliance with applicable regulations (e.g., QSR, GMP, ISO) pertaining to the product's life cycle and distribution regions. The Quality Manager acts as a liaison with Divisions, Suppliers, Manufacturing, and/or Operations to ensure quality products and customer satisfaction. They will manage complaints, develop new approaches to solve investigation problems, and identify and execute continuous improvement projects. The position also assists the division in product evaluation from a quality assurance and regulatory compliance standpoint, and in planning design, testing, inspection, and process validations. Ensuring all quality issues are resolved to customer satisfaction in a timely manner and resolving product or production quality issues by interfacing with internal and external customers are key aspects of this role. Management responsibilities include overseeing professional employees/teams or non-professional employees through supervisors, managing day-to-day operations, and potentially having limited budgetary responsibility. The role involves interpreting and executing policies, recommending new policies, providing general guidelines, and managing staff functions including hiring, performance reviews, training, and development.

Requirements

Bachelor’s degree in Engineering, Science, or Technical Field, or relevant 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).
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 a pivot table).
Position requires travel up to 25% of the time for business purposes (within state, out of state and/or internationally).

Nice To Haves

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

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.
Oversee professional employees/teams OR typically manages non-professional employees through Supervisors in manufacturing, distribution or office environments.
Manage day-to-day operations of a group of employees.
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.