QA Investigator: Medical Device Complaints & Lab Compliance
Spectraforce Technologies, Inc.
Spectraforce Technologies, Inc. is seeking a Quality Assurance (QA) Specialist I to support product complaint documentation, investigations, and data summarization in North Chicago, IL. This 6-month assignment focuses on determining testing steps and ensuring compliant documentation within GMP/GLP frameworks. The ideal candidate has a science/tech background, lab experience, strong communication, and the ability to manage multiple tasks with Agile practices to support QA lab processes and #J-18808-Ljbffr Spectraforce Technologies, Inc.
- ...and Regulatory Affairs (QA/RA) to support our expanding... ...artwork and labeling compliance, customer complaints, supplier qualifications,... ...Support customer complaint investigations, nonconforming product evaluations... ...of ISO 13485, FDA medical device regulations, cGMP, and...ComplaintsMedical deviceFull timeWork at office
- ...n This is an execution role, not a compliance desk job. You'll own manufacturing quality... ..., and own field quality and complaint investigation. \n \n You'll report directly to... ...\n \n ~10+ years of progressive medical device quality operations experience, with...ComplaintsMedical deviceContract workImmediate startWorldwide
- Medline Industries, a leading medical device company, seeks a Clinical Product Surveillance... ...with active RN licensure to investigate post-market complaints and support clinical safety... ..., supporting safe product use and compliance with regulations. #J-18808-Ljbffr...ComplaintsMedical device
$165k - $230k
...Director, Global Quality and Compliance Excellence BioSpace - AbbVie... ...issues today and address the medical challenges of tomorrow. We strive... ...Site leadership, Quality Lab leadership, global functional... ...combination products, medical devices, tissue, and cosmetics for future...Medical deviceFull timeTemporary workLocal area- ...to quality teams, ensuring product quality and regulatory compliance for assigned departments. This role develops strategy,... ...company goals. The position requires extensive experience in medical device/drug-related QA, strong regulatory knowledge, and proven leadership in...Medical device
- ...products in diagnostics, medical devices, nutritionals and... ...instruments, providing lab results for millions... ...for meeting the compliance requirements for Medical... ...Work On Review medical complaints and potentially... ...Group and Complaint Investigations Group) to gather appropriate...ComplaintsMedical deviceWorldwide
- Medline Industries, LP seeks a senior Quality leader to provide direction to quality teams, develop QA strategy, and drive compliance across products and processes. This role partners with suppliers, divisions and manufacturing to ensure high-quality, on-time delivery and...Medical device
- ...Quality Leader in Illinois to drive strategy, oversee multiple QA departments, and ensure compliant, high-quality Medline-branded... ...on-time, safe products. The role requires 7+ years in regulated medical device or related fields, strong data analysis, and advanced Excel...Medical device
$154k - $231k
...to Quality team(s) to ensure quality and compliance for the applicable products and... ...Provides leadership and management to site QA/QC teams.Strategic, tactical and operational... ...experience related to the design/operation of medical device or drug combination product platforms,...Medical deviceMinimum wageFull timeLocal areaWorldwide- ...Responsibilities Develop and execute R&D QA transformation roadmap including... ...functional initiatives in pharmaceutical, medical device, clinical, or quality environments ~ Proficiency... ...~ Understanding of quality systems, compliance expectations, and change management in...Medical device
- ...Job Description QA Associate/Specialist | Medical Devices | Maryland \n \n X4 Life Sciences... ...of quality and regulatory compliance across the U.S. and... ...Helping manage customer complaints, nonconformances and CAPAs, from investigation through to closure \n Supporting...ComplaintsMedical deviceImmediate start
$154k - $231k
...to Quality team(s) to ensure quality and compliance for the applicable products and... ...managers in developing and implementing QA programs.Oversee QSR for assigned department... ...experience related to the design/operation of medical device or drug combination product platforms,...Medical deviceMinimum wageFull timeLocal areaWorldwide$67k - $101k
...Specialist is responsible for both product complaint remediation and processing new... ...MDR submissions are completed in full compliance with FDA reporting requirements, 21 CFR... ...Abilities Basic understanding of FDA Medical Device Reporting (21 CFR 803) and complaint handling...ComplaintsMedical deviceMinimum wageWork at officeLocal areaWorldwide$154k - $231k
...SummaryResponsible for leading and managing medical events, Medical Device Vigilance, and Drug/Combination and... ..., regulatory reporting, and global compliance throughout the organization.Provide... ...clinical evaluation, medical event complaint management; reportability assessment...ComplaintsMedical deviceMinimum wageFull timeLocal areaWorldwide$18 - $20 per hour
...tools? We're looking for a Quality Inspector to join a medical device manufacturing operation where quality, accuracy, and attention... ...do not meet specifications. Supporting NCRs, CAPAs, complaint investigations, and root cause analysis . Partnering with Production...ComplaintsMedical deviceHourly payTemporary workLocal areaDay shift- ...relocation assistance** The Zifo Lab Computing Analyst provides... ...as well as in-lab validation/compliance services when applicable. The... ..., Bio-technology, Bio-medical engineering, Chemical engineering... ..., Manufacturing QC, Medical Devices, specialty chemicals and...Medical deviceFull timeWork at officeRelocation packageFlexible hours
- ...ancestry, color, family or medical care leave, gender... ...assurance, and compliance functions and ensures... ..., and customer complaints including investigation, root cause analysis... ...validated processes and Device Master Records, as well... ...a large, diverse QA and QC team required...ComplaintsMedical device
- ...seeking a senior Quality leader to direct quality teams and ensure compliance across products and processes. You will translate strategic... ...knowledge of QSR/GMP/ISO standards, extensive experience in medical-device environments, and strong leadership for multi-department...Medical device
- ...issues today and address the medical challenges of tomorrow. We strive... ...products and medical devices. Act as the primary interface... ...& Logistics, Marketing & BD, QA, Regulatory, MNO, AbbVie manufacturing... ...assigned accounts, including compliance, regulatory updates, capacity...Medical deviceContract workLocal areaWorldwide
$23 per hour
...and documentation management to ensure compliance with internal requirements and... ...process deviations, procedure deviations, complaints, regulatory audits, customer audits, and... ...experience in inspection, quality assurance, medical device, pharmaceutical, healthcare, or...ComplaintsMedical devicePermanent employmentFull timeContract workTemporary workWork at office- ...extension of Client’s Medical Affairs organization,... ...disease thought leaders and investigator discussions. \n \n... ...position will include compliance, regulatory and study... ...of concern or product complaints in accordance with... ...diagnostics, and medical device fields have turned to...ComplaintsMedical deviceFull timeTemporary workFor contractorsWork at officeLocal areaWork from homeNight shift1 day per week
- A leading technology firm in Lake Forest seeks a Mechanical Engineer to manage product design and compliance in medical device development. Candidates must hold a degree in Mechanical Engineering and possess experience in medical quality processes along with familiarity...Medical device
- ...health issues today and address the medical challenges of tomorrow. We... ...data integrity, foster regulatory compliance, and contribute to the overall success of drug/device development programs. The Associate... ...about improving how R&D QA operates through data-driven decision...Medical deviceFull timeLocal area
$129.3k - $258.7k
...and products in diagnostics, medical devices, nutritionals and branded... ...related to nonconformance, investigation and Corrective And Preventive... ..., risk management, complaint management, design controls... ...management system, regulatory compliance, and business objectives. Act...ComplaintsMedical deviceShift work- ...with a focus on retrospective complaint review reportability... ...reportable events. Support compliance with FDA Quality System Regulations... ...Strong ability to interpret medical narratives, product information... ...experience in a medical device or pharmaceutical environment...ComplaintsMedical device
- ...Medical Reviewer/Safety Reviewer III Are you a licensed RN with... ...specialized expertise in medical device risk management and post-... ...gatekeeper role in evaluating complaint reports, handling medical assessments, and ensuring compliance with global safety regulations...ComplaintsMedical deviceContract workRemote work
- ...subsection of our Quality Management System, such as device master records, customer complaints, recalls, or product holds. You will help build and maintain... ..., inspection criteria and test reports while ensuring compliance with FDA/ISO standards. The role emphasizes...Complaints
$126k - $175k
...regulatory agencies regarding device information or issues. Includes... ...and ongoing activities for compliance with FDA, Health Canada and other... ...rules including those for medical devices products. 7. Manages &... ...Motivated individual with hands-on RA/QA experience, excellent...Medical deviceWork at officeWorldwide- ...a subsection of our Quality Management System such as device master records, customer complaints, product holds, recalls, or incoming quality. You will... ...collaborate with cross-functional teams to ensure FDA/ISO compliance, track progress, review documentation #J-18808-Ljbffr...Complaints
$109.5k - $208.5k
...health issues today and address the medical challenges of tomorrow. We strive... ...for adequacy, consistency, and compliance Maintain the audit schedule Represent RD QA for Dossier Program related... ...years’ experience in the Medical Device or Pharmaceutical industry, Experience...Medical device
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