Medical Device Quality Assurance Auditor
EXALTA Group
EXALTA Group in Wisconsin (Kenosha) seeks a senior quality auditor to ensure compliance with FDA QSR and ISO 13485, lead internal and supplier audits, and drive CAPA and continuous improvement in manufacturing. The role requires 5+ years of medical device QA experience, strong documentation control, and the ability to train staff across functions, with travel as needed. Excellent communication and problem-solving skills are essential. #J-18808-Ljbffr EXALTA Group
- ...required the person to have Knowledge with FDA regulations for Medical Devices, and ISO 13485 Medical Device-QMS-Requirements for Regulatory... ...activities, detection of problem areas, and delivering quality inspection outcomes. In addition, they are in charge of planning...Medical deviceWork at office
$24 - $26 per hour
...Job Title: Quality Assurance Associate Job Description The Quality Assurance Associate supports a robust quality system by managing product... .... Evaluate complaints to determine whether submission of a Medical Device Report (MDR) or other Vigilance Report is required based on...Medical deviceContract workTemporary workWork at officeRemote workMonday to FridayDay shift- ...Title - Quality Analyst Location - 13900 Grandview Pkwy, Sturtevant, WI - M-... ...: $23- $24/HR on W2 Industry - Medical Device Execute Investigations, Root Cause Analysis... ...Required Experience in Quality Assurance and/or other regulated industry or...Medical device
- Title : Quality Manager | Medical Device / ISO 13485 Basic Purpose and Function: The Quality Manager is responsible for developing, implementing, maintaining... ...Lead and develop Quality Specialists, Technicians, Auditors, and Inspectors. Establish departmental goals and...Medical device
$159.43k
...Duties: • Develop, implement, and maintain the project-specific Quality Assurance Surveillance Plan (QASP) in compliance with Federal... ...pregnancy, pregnancy related conditions, childbirth and related medical conditions, sexual orientation, gender identity or gender expression...SuggestedContract workFor contractorsWork experience placementFor subcontractorH1bImmediate startFlexible hours- ...manufacturing solutions, delivering superior quality and support to Original Equipment... ...aerospace, industrial and semiconductor systems, medical, multimedia, computing and storage,... ...regions throughout the world. Quality Control Auditor Job Purpose Sanmina is currently seeking...Permanent employmentWork at office
- Mindlance is seeking a Manager for Design Quality to ensure compliance in medical devices lifecycle. The role requires 8+ years in the industry, focusing on quality assurance and regulatory compliance for products like infusion pumps and autoinjectors. The ideal candidate...Medical device
- ...Job Description Design Hire is seeking a Quality Manager to lead quality systems, inspection activity, and compliance efforts... ...Prior quality leadership or management experience required. •Medical device manufacturing experience strongly preferred. •Working...Medical deviceTemporary workLocal area
- ARCH is seeking a Quality System Management Representative for the Elmhurst, IL and Kenosha, WI facilities to promote regulatory and quality system compliance. The role requires training personnel on the Quality System and regulatory standards, and ensuring processes are...Medical device
- ...Quality Assurance Analyst Help power one of the nation's largest e-commerce operations. As a Quality Assurance Analyst at Uline, you'll play a key role in ensuring our websites deliver a seamless, reliable experience for customers and employees. Partner with teams to...
- Medline is seeking a Director of Quality Assurance for our Waukegan, IL manufacturing site. You will lead QA/QC teams, align site processes with QSR/GMP/ISO standards, and drive regulatory compliance across product life cycles and regions of distribution. Collaborate with...Medical device
- Affiliated Engineers, Inc. is seeking a Senior Mechanical QA/QC Agent in Wisconsin to oversee quality control challenges and ensure adherence to project requirements. The role involves mentoring team members and resolving technical issues on site. The ideal candidate has...
- Affiliated Engineers, Inc. (AEI) is hiring a Mechanical QA/QC Agent to resolve quality-control challenges and implement site‑wide QC plans across mission‑critical facilities. The role emphasizes field inspections, coordination with contractors, and adherence to project...For contractors
- ...Major Responsibilities Troubleshoots, maintains, and repairs (primarily) non-imaging diagnostic and therapeutic medical devices using standard electronic test equipment. Also installs, calibrates, and tests new medical electronic devices and systems. Escalates situations...Medical deviceContract workWork experience placementWork at officeShift work
- Actalent in Wisconsin is seeking a Quality Assurance Associate to support a robust quality system by handling complaints, investigations, and regulatory reporting. You will document issues, provide technical support, review records, and lead investigations into deviations...Medical deviceContract workDay shift
$23 per hour
...Senior Medical Device Technician Position facilitates day-to-day operation of a medical device testing laboratory (BP monitors, TENS units, and nebulizers) responding to consumer complaints. There is no direct interaction with customers. Duties include transporting...Medical deviceWork experience placementWork at office- Affiliated Engineers, Inc. in Kenosha, WI seeks an Electrical QA/QC Agent to resolve quality control challenges and develop delivery plans based on project documents, field surveys, specifications, and code research. You will perform site walks, assist contractors and site...For contractors
- ...difference in the world through cutting-edge medical technology. Our mission is to be the... ...for all. We are seeking a dedicated Quality Manager to join our team. In this vital... ...and FDA requirements. Maintain Medical Device Files and records per ISO 13485...Medical deviceFull timeRelocationShift work
$154k - $231k
...SummaryResponsible for providing leadership and direction to Quality team(s) to ensure quality and compliance for the applicable products... ...7 years of experience related to the design/operation of medical device or drug combination product platforms, design controls, risk...Medical deviceMinimum wageFull timeLocal areaWorldwide- ...Quality Manager Manufacturing Position Overview We are seeking an experienced Quality Manager to lead quality operations... ...metrology, and structured problem-solving. Experience supporting medical device or other highly regulated manufacturing environments is...Medical deviceFull timeDay shift
$25.7 per hour
Production Quality Associate Silgan Closures - Kenosha, WI Pay: $25.70 per hour + Shift Differential + Bonus Opportunity + Excellent... ...opportunity based on safety, quality, productivity, and waste reduction Medical, Dental, Vision, Prescription, Life, and AD&D Insurance Short-...Hourly payFull timeTemporary workMonday to FridayShift workNight shiftDay shiftAfternoon shift- ...area Overview: The Batch Disposition QA Representative will oversee batch disposition and release processes, ensuring compliance with quality, regulatory, and safety standards for commercial pharmaceutical production. Key Responsibilities: Execute batch disposition...Contract workFlexible hours
$40 - $55 per hour
...data center projects meet contract documents, specifications, quality standards, and commissioning requirements. This role plays a key... ...available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 4...Contract workTemporary workWork at office- ...opportunity with one of our Fortune 500 Healthcare Clients. Duties: Quality Assurance is responsible for developing and implementing a compliant... ....S. based job. In accordance with federal law reasonable accommodations for medical or religious exemptions will be considered....Contract workImmediate start
$154k - $231k
...Summary Responsible for providing leadership and direction to Quality team(s) to ensure quality and compliance for the applicable... ...least 7 years of experience related to the design/operation of medical device or drug combination product platforms, design controls, risk...Medical deviceMinimum wageLocal areaWorldwide$16.5 - $19 per hour
...Quality Assurance Associate Waukegan, IL 60085 Overview Salary Range $16.50 - $19.00 Hourly Job Shift 3rd Shift Education Level High... ...religion, marital status, age, national origin, disability, medical condition, pregnancy, gender (orientation or identification),...Hourly payContract workWork experience placementWork at officeLocal areaFlexible hoursShift workNight shift- ...award-winning portfolio of injectables, devices, and skincare products empowers healthcare... ...maintaining and improving electro-mechanical medical device manufacturing, process... ...product design to improve productivity and quality of current and future products while expecting...Medical deviceFull timeContract work
- ...aspects of heart pacing. Administers medications according to approved policy/procedure... ...measures for any further changes in the device that may be required. Demonstrates... ..., to physician or supervisor. Assures the accuracy and completeness of messages...Medical deviceWork at officeRemote work
- Vonco Products, LLC is seeking a Quality Manager to lead the ISO 13485 quality system and ensure compliance with regulatory and customer requirements in a medical device environment. This role partners with Operations, Engineering, Supply Chain, and Customer Service to...Medical device
$85k - $100k
A recruitment firm is looking for a Quality Control Specialist in Pleasant Prairie, Wisconsin. The ideal candidate will have over 5 years of quality experience in the medical device industry, with a strong understanding of ISO13485 and FDA standards. Responsibilities include...Medical device
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