<![CDATA[iMPact Business Group: jobboards]]> https://JOBS.IMPACTBUSINESSGROUP.COM/ en-us <![CDATA[Medical Device Inspector - 1st Shift]]> Our client, a Global Leader in the Medical Device Industry, has an immediate opening for a 1st Shift Medical Device Inspector for a 6-month+ contract.  Our client offers results-driven people a place where they can make a difference - every day!  You will also have the opportunity to work with other like-minded, self-directed, and detail-oriented Top Talents in an extremely collaborative and professional environment. 

 

Under close to general supervision, this position will support the goals in processing incoming raw materials and components. The QA Inspector will be required to inspect incoming components & finished goods against approved specifications and incoming inspection plans using standard procedure, gauges, tools, and equipment.


Monday through Friday: 8:00am - 4:00pm CST

 

Responsibilities

 

  • Perform documentation activities that adhere to cGMP and GDP.
  • Perform inspection activities for various components & finished goods, ensuring conformance to the part specification or drawing.
  • Use of various measurement tools and instruments including: calipers, scales, thickness gauges, force gauges, optical comparator, and other systems.
  • Perform inspection activities of printed materials against master documents for differences
  • Communicate with Warehouse and Manufacturing personnel regarding the release and movement of materials/components
  • Maintain the general upkeep and cleanliness of the IQA Inspection Area
  • Filing and copying of records for record retention
  • Maintaining IQA Office inventory to appropriate levels
  • Perform other duties as assigned.
]]> Tue, 14 Jul 2026 00:00:00 EDT Requirements 

  • High school degree with preferred 1-2 years of quality experience; or Associates Degree in a Science or Engineering field.
  • Ability to follow proper documentation with a high level of attention to detail.
  • Ability to take direction, work independently and be adaptable in an ever-changing environment.
  • Capability to handle computer use and work in multiple systems.
  • Proficiency with Microsoft Office (Word, Excel, etc.) required.
  • Possesses a high level of personal integrity and self-control.
  • Physical capability to lift 60 pounds and be mobile throughout a large plant.
  • Accepts direction and constructive criticism.
]]> 0 <![CDATA[Medical Device Inspector - 2nd Shift]]> Our client, a Global Leader in the Medical Device Industry, has an immediate opening for a 2nd Shift Medical Device Inspector for a 6-month+ contract.  Our client offers results-driven people a place where they can make a difference - every day!  You will also have the opportunity to work with other like-minded, self-directed, and detail-oriented Top Talents in an extremely collaborative and professional environment. 

 

Under close to general supervision, this position will support the goals in processing incoming raw materials and components. The QA Inspector will be required to inspect incoming components & finished goods against approved specifications and incoming inspection plans using standard procedure, gauges, tools, and equipment.

 

Monday through Friday: 2:00pm - 10:00pm CST

 

Responsibilities

 

  • Perform documentation activities that adhere to cGMP and GDP.
  • Perform inspection activities for various components & finished goods, ensuring conformance to the part specification or drawing.
  • Use of various measurement tools and instruments including: calipers, scales, thickness gauges, force gauges, optical comparator, and other systems.
  • Perform inspection activities of printed materials against master documents for differences
  • Communicate with Warehouse and Manufacturing personnel regarding the release and movement of materials/components
  • Maintain the general upkeep and cleanliness of the IQA Inspection Area
  • Filing and copying of records for record retention
  • Maintaining IQA Office inventory to appropriate levels
  • Perform other duties as assigned.
]]> Tue, 14 Jul 2026 00:00:00 EDT Requirements 

  • High school degree with preferred 1-2 years of quality experience; or Associates Degree in a Science or Engineering field.
  • Ability to follow proper documentation with a high level of attention to detail.
  • Ability to take direction, work independently and be adaptable in an ever-changing environment.
  • Capability to handle computer use and work in multiple systems.
  • Proficiency with Microsoft Office (Word, Excel, etc.) required.
  • Possesses a high level of personal integrity and self-control.
  • Physical capability to lift 60 pounds and be mobile throughout a large plant.
  • Accepts direction and constructive criticism.
]]> 0 <![CDATA[GxP Data Lab Technician]]> Our client, a Global Medical Device Manufacturer, has an immediate opening for a GxP Data Lab Technician for a 9 Month+ contract.   Our client offers results-driven people a place where they can make a difference - every day!  You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment. 

 

Performs functions associated with quality control/quality assurance operations, including working with chemists/microbiologists to conduct simple reviews (reagent review/pH data review, visual data review), complex data review (chromatographic - HPLC/GC, titrator, density meter, FTIR), and perform investigations for OOS/OOT results. Uses electronic programs to evaluate data to assist in assessing and documenting results of quality assurance and control processes. Performs other activities as needed.

 

1st Shift  (7am - 3pm) Sunday - Thursday

 

Position Description 

 

  • Majority of the work will be desk work reviewing data within the electronic systems such as (Empower, LabX, LabVantage 8)
]]> Tue, 14 Jul 2026 00:00:00 EDT What you need

 

  • 2+ years working in a GxP laboratory environment.
  • Proficient in Microsoft Office applications.
  • Strong written and oral communication skills (English).
  • Experience working in current Good Manufacturing Practice (cGMP) or other cGxP environments.
  • Experience performing analytical chemistry data review.

 

Knowledge/Competencies 

 

  • Experience using Laboratory Information Management System (LIMS).
  • Experience reviewing chromatography data within Empower, LabX, and Omnic software.
]]> 0 <![CDATA[QMS Systems Specialist]]> Our client, a Global Medical Device Manufacturer, has an immediate opening for a QMS Systems Specialist for a 12 Month+ contract.   Our client offers results-driven people a place where they can make a difference - every day!  You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment. 

 

We are seeking a highly motivated Staff Quality Systems Specialist (Contractor) to support QMS integration activities by leading and owning the Change Control process within a regulated medical device environment.


 In this role, you will ensure that all changes are appropriately documented, assessed for impact, and effectively implemented in alignment with quality and regulatory requirements. You will also mentor cross-functional stakeholders on proper change execution and support the integration of quality system processes across the organization.


 This position is ideal for a detail-oriented professional with strong technical writing skills and a deep understanding of how quality system processes interact (e.g., change control, document control, training, and records management).

 

This role requires close collaboration with teams in Germany and flexibility to align with CET/CEST working hours.

 

Position Description 

 

  • Own and manage the Change Control process to ensure compliance, consistency, and effectiveness
  • Review and approve change records for completeness, accuracy, and appropriate impact assessments
  • Ensure changes are implemented appropriately, including verification of downstream activities (e.g., documentation updates, training completion, record retention)
  • Drive process improvements and standardization to support integration efforts
  • Evaluate process gaps and define compliant, scalable solutions
  • Collaborate with cross-functional teams to align change activities with integration timelines and business needs
  • Mentor and guide change owners and stakeholders on proper change control processes
  • Provide coaching on impact assessment, documentation expectations, and process requirements
  • Promote consistent and high-quality execution of change activities across the organization
  • Develop and revise quality system documentation, including procedures, work instructions, and change records
  • Ensure documentation is clear, accurate, and compliant with internal and regulatory requirements
  • Partner with Quality, Regulatory, R&D, and Operations teams to ensure alignment on changes and integration efforts
  • Act as a quality representative in project discussions and integration activities
  • Communicate progress, risks, and recommendations to key stakeholders
]]> Wed, 24 Jun 2026 00:00:00 EDT What you need

 

  • Bachelor's degree in engineering, science, or a related field
  • 5+ years of experience in a regulated environment (medical device preferred)
  • Proven experience with Change Control processes and quality system integration or harmonization
  • Experience supporting integration of products, systems, or acquired businesses is strongly preferred
     

REQUIRED

 

  • Strong knowledge of Quality Management Systems (QMS) and applicable regulatory requirements (e.g., FDA, ISO 13485, EU MDR)
  • Deep understanding of interactions between Change Control, Document Control, Training, and Records processes
  • Excellent technical writing and documentation skills
  • Strong organizational, problem-solving, and project coordination abilities
  • Ability to influence, mentor, and drive consistent process execution across cross-functional teams
  • Ability to manage multiple priorities in a fast-paced, integration-focused environment
  • Strong attention to detail and commitment to quality and compliance
  • Collaborative mindset with a proactive, solution-oriented approach
  • Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, Teams, and SharePoint
  • Fluency in English (written and verbal)
  • Ability to work flexible hours to accommodate German time zones

 

Preferred qualifications:

 

  • Experience supporting QMS integration in a global environment
  • German language proficiency (written and verbal)
]]> 0 <![CDATA[Quality Systems Coordinator]]> Our client, a Global Medical Device Manufacturer, has an immediate opening for a Quality Systems Coordinator for a 12 Month+ contract.   Our client offers results-driven people a place where they can make a difference - every day!  You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment. 

 

The Senior Quality Systems Coordinator (Contract) supports site integration activities by coordinating core Quality System workflows, including Change Control, Nonconformance (NC), and Corrective and Preventive Action (CAPA). This role is responsible for assessing the current state of quality system processes, driving execution through structured coordination, and providing clear visibility into system performance and risks. Additionally, this role will support document control activities and act as a SharePoint administrator to ensure accurate and compliant document management. 

 

This role requires close collaboration with teams in Germany and flexibility to align with CET/CEST working hours.

 

Position Description 

 

  • Coordinate Change Control, Nonconformance, and CAPA workflows to ensure timely progression, closure, and compliance.
  • Monitor record status, identify bottlenecks, and proactively drive actions to meet integration timelines
  • Facilitate cross-functional alignment to ensure completeness, accuracy, and consistency of quality records
  • Ensure downstream impacts (e.g., document updates, training, implementation activities) are identified and tracked
  • Develop and communicate summaries, dashboards, and status updates to stakeholders and leadership
  • Draw conclusions on overall system health and recommend targeted actions
  • Schedule and lead recurring and ad hoc meetings to drive progress, remove barriers, and ensure accountability
  • Partner with cross-functional stakeholders to define priorities and align on next steps
  • Document meeting outcomes, action items, and decisions, ensuring follow-up to closure
  • Identify and escalate risks, delays, or compliance concerns in a timely and structured manner
  • Ensure critical issues are visible and appropriately managed through resolution
  • Manage document control activities, including document creation, review, approval, and lifecycle management
  • Serve as SharePoint administrator to maintain document repositories, permissions, and structure
  • Ensure document organization supports accessibility, traceability, and compliance requirements
  • Support migration and harmonization of documents as part of integration activities
]]> Wed, 24 Jun 2026 00:00:00 EDT What you need

 

  • Bachelor's degree in science, engineering, business, or related discipline preferred
  • 3-6+ years of experience in quality systems, regulatory, or compliance roles within a regulated industry

 

Knowledge/Competencies 

 

  • Working knowledge of quality system processes (Change Control, CAPA, Nonconformance, Document Control)
  • Proficient in Microsoft Office tools, including Teams, SharePoint, Excel, PowerPoint, and Word
  • Experience using SharePoint as a document management platform (including administration and maintenance)
  • Ability to create reports, dashboards, and presentations to communicate status and insights
  • Detail-oriented with strong organizational skills
  • Customer service-focused with a proactive and responsive mindset
  • Action-oriented, with the ability to drive execution and accountability
Ability to work flexible hours to accommodate German time zones
]]> 0 <![CDATA[Manufacturing Engineer]]> Our client, a Global Medical Device Manufacturer, has an immediate opening for a Manufacturing Engineer for a 6 Month+ contract.   Our client offers results-driven people a place where they can make a difference - every day!  You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment. 

 

Provide engineering support for complex manufacturing equipment for the high-volume manufacturing of medical devices. Provide technical, engineering, validation and documentation support.

 

 

Position Description 

 

As a Manufacturing Engineer, you will provide technical and engineering support for manufacturing equipment that supports Needle Punch and Label Printing Operations. Responsibilities include:

 

  • Support engineering and project management in FAT, installation, and commissioning of new equipment.
  • Develop equipment and utility layouts using AutoCAD (or similar) to support department relocation and installation of new equipment.
  • Support installation of new equipment, including layout planning, utility coordination, and integration into existing processes.
  • Interface with OEMs, contractors, and internal engineering teams to resolve design gaps and coordinate field changes on the fly.
  • Develop and maintain process FMEAs and control plans for new and existing equipment.
  • Complete process validations including VP, URS, IQ, OQ, PQ and associated documentation.
  • Develop appropriate supporting documentation, SOPs and work instructions compliant with Good Manufacturing Practices (GMP).
  • Collaborate with product and manufacturing engineering, equipment vendors, maintenance technicians and operations leadership to troubleshoot process and equipment issues.
  • Support line performance monitoring and lead practical problem solving (PPS) projects to remediate systemic issues.
  • Participating in advocacy activities of a more advanced technical, tactical, or strategic nature.
]]> Tue, 23 Jun 2026 00:00:00 EDT What you need

 

  • B.S. in Engineering or related field required.
  • Two years' experience in manufacturing engineering, mechanical engineering, or related field.
  • Demonstrated interest and experience supporting manufacturing operations, troubleshooting automation equipment, and implementing process improvements.
  • Hands-on technical contributor comfortable working on the floor, assisting with equipment placement, alignment, and startup activities.

 

Preferred qualifications:

 

  • Medical Device industry experience (ie. internship).
  • Demonstrated experience writing and executing validations (IQ, OQ, PV, etc.).
  • Demonstrated hands on experience working in a manufacturing environment.
  • Demonstrates excellent interpersonal communication, collaborative teamwork, and problem solving.
  • Familiarity with reading electrical schematics.
]]> 0 <![CDATA[Senior Project Manager, PLM Implementations]]> *** Please note: This role does NOT allow for Visa sponsorship, now or in the future ***


Our client, a Global Leader in the Medical Device Industry, has an immediate opening for a Senior IT Project Manager - PLM Implementations, for a 12-18 month contract.  Our client offers results-driven people a place where they can make a difference - every day!  You will also have the opportunity to work with other like-minded, self-directed, and detail-oriented Top Talent in a highly collaborative and professional environment. 

 

This role will support a PLM System migration / implementation project moving from a legacy Oracle Agile PLM system to the MasterControl PLM system. 


This role is using a hybrid onsite work model in Cary, IL with NO option for full remote. Candidates unable to work onsite in Cary, IL will NOT be considered.   


Duties -

* Formal Project Management - planning, collaboration, risks, milestones, communication, budget

* Lead the end-to-end lifecycle of a PLM replacement project, from initiation through go-live and post implementation stabilization

* Drive delivery of all project milestones

* Proactively identify risks and create mitigation strategies

* Ensure System procedures are updated to reflect new PLM functionality and workflows

*  Lead transition to sustainment and support teams, establishment of sustainable post go-live support structures

 

]]> Thu, 28 May 2026 00:00:00 EDT Required Skills

 

  • Proven PM experience leading end-to-end enterprise system implementations (PLM, ERP, MES, and related) including data and records migration from legacy systems
  • Experience managing system integrations between PLM and MES systems
  • Understanding of GxP system validations
  • Experience delivering projects in regulated (GxP) environments
  • Excellent project management skills, including planning, risk management, and stakeholder communication
  • Strong leadership and accountability for end-to-end outcomes
  • Ability to translate business requirements into system scope and execution plans
  • Excellent written and verbal communication skills, including executive level reporting
  • Proven ability to manage complexity, ambiguity, and competing priorities
  • Collaborative, results-driven approach with a focus on business value and operational continuity

Certifications:

  • PMP or equivalent, required
  • CIMdata PLM Certificate, preferred
  • MasterControl Certified Expert, preferred


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