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Spectraforce Technologies

Quality Systems Manager

Spectraforce Technologies, North Chicago, Illinois, us, 60086

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Job Title: Quality Systems Manager (Quality Systems and Supplier Risk Management)

Location:

Waukegan, IL 60085 - This is an

ON-SITE

role, 40 hours per week (Monday through Friday).

Duration:

6 Months (Possible Extension)

Work Schedule:

Monday through Friday (M-F)

Expected Start Date:

Mid-January

Role Overview The Manager, Quality Systems is responsible for providing quality assurance (QA) support for Quality Systems and Supplier Risk Management processes across the company's global network. This is a corporate-facing, non-entry-level role supporting various manufacturing processes, including pharmaceutical products, medical devices, cosmetics, combination products, and biologics. This role is critical in ensuring that all product, process, or system-related quality activities, from raw material inspection through final product shipment, are in compliance with Corporate and governmental regulations.

Essential Qualifications & Experience

Education:

Bachelor's degree in Life Sciences (other scientific degrees may be considered) ideal.

Experience:

8 or more years of Quality experience in a pharma or medical device manufacturing environment.

Required Skills

Extensive experience writing

Quality System procedures

and process documents.

Strong experience in

Supplier Controls , including managing supplier-related quality activities.

Excellent

written and oral communication skills ; ability to clearly communicate information to global teams.

Experience working with the

TrackWise

system is

ideal .

Experience working with global teams and coordinating across different manufacturing sites/regions.

Nice to Have:

ASQ certification.

Key Responsibilities

Support and own aspects of Quality Systems and Supplier Risk Management on a global scale.

Write, revise, and maintain Quality System procedures, process documents, and other controlled documentation.

Manage quality activities related to

Supplier Controls , including coordination with global suppliers and teams (US, Europe, and Asia).

Coordinate with various manufacturing sites and affiliates, organize meetings, and ensure timely follow-ups.

Independently manage tasks, multitask, and drive projects to completion.

Translate strategy into tactical objectives to deliver strategic plans and regulatory updates.

Provide support to specific areas as needed, such as the Document Center, Device QA, Labeling, Validation, Training, and Quality Intelligence.

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