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Immediate hiring for Configuration Assurance Administrator or Change Order Specialist - Brooklyn Park, MN at Brooklyn, New York, USA
Email: suzanne.rogers@concorditsystems.com
From:

Suzanne Rogers,

Concord IT Systems

suzanne.rogers@concorditsystems.com

Reply to:   suzanne.rogers@concorditsystems.com

Job Title: Configuration Assurance Administrator/Change Order Specialist

Location Brooklyn Park, MN, USA

Long term

Responsibilities:
Work with project teams to facilitate creation and driving of engineering Change Orders (COs) through the sign-off process.
Work with Agile Product Lifecycle Management (PLM) system and Quality configuration managers to release change orders and drive process improvement.
Interact with cross-functional team members as required to process COs.
Monitor the status of ongoing change orders and notify team members of required approvals or document updates.
Review submitted documents for all applicable regulations, standards, best practices and company procedures.
Follows process closely to ensure proper change order type, document type, BOM structure, signature requirements, alignment with product model numbers, GTINs, and UPNs, and alignment with other enterprise systems.
Construct plans in spreadsheet or other format and communicate status to project team.
Other possible assignments include supplier check-ins, creating and maintaining compliance records for applicable hazardous substance regulations, compose & maintain compliance documentation.

Must Have - Minimum Requirements:
BS degree with 2 years professional experience

Nice to Have Preferred Requirements:
Working knowledge of PLM systems and Change Management basics.
Quality Systems and Quality Records knowledge.
Basic knowledge of Medical Device manufacturing requirements.
Experience in Medical, Pharma or high reliability product industry.
Experience managing change orders using Agile tools for Product Lifecycle Management.
Experience managing Bills of Materials in pre- and post-production settings.
Excellent attention to detail.
Strong technical writing, communication skills.
Solid organizational and time-management skills.
Exposure to blood management, cardiac ablation or perfusion medical devices.
Familiarity with Product Development Process, Regulatory Submission Process, Quality Management Systems, FDA, EU Regulations to ensure changes to process/product, quality system documents follow procedures and remain compliant to regulations and standards.

--

Thanks and Regards,

Suzanne Rogers

US IT Recruiter

Cell : (312) 585-2508

Desk No.: 17866280721

Email Id: suzanne.rogers@concorditsystems.com

Keywords: information technology Colorado Idaho Minnesota
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08:42 PM 21-Jul-23


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