Quality Manager

Location: Township of Northfield

## Quality Manager Apply:
Hybrid:
Northfield, Illinois:
Full time:
Posted Today:
R2619037
** 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, or equivalent experience.

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 (21

CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR).Knowledge / Skills / Abilities
* Broad technical knowledge of relevant standards and regulations (21

CFR 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.

The anticipated salary range for this position:$ - $ 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.