Infotree Global Solutions
Quality Assurance Specialist (Medical Devices)
Infotree Global Solutions, Florence, South Carolina, United States, 29506
Quality Assurance Specialist (Medical Devices)
Quality Assurance Specialist (Medical Devices)
3 days ago Be among the first 25 applicants Infotree Global Solutions provided pay range
This range is provided by Infotree Global Solutions. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$25.00/hr - $28.00/hr Direct message the job poster from Infotree Global Solutions Technical Recruiter at Infotree Global Solutions(Hiring for USA, UK, Sweden and other Nordic Countries)
Description: We are looking for an experienced Quality Assurance Specialist to manage and support quality systems and compliance processes in a regulated environment. The ideal candidate will bring strong analytical abilities, problem-solving expertise, and hands-on experience with quality management in line with ISO standards and FDA regulations. Key Responsibilities: Collaborate with suppliers to investigate product-related quality concerns and deliver clear communication of root causes and corrective/preventive actions (CAPAs) to customers. Serve as the liaison between internal teams, customers, and suppliers during quality issue resolution, ensuring timely and effective problem management. Process the download and distribution of Complaints daily. Review, validate, and share investigative findings and resolution steps with internal and external stakeholders to maintain transparency and alignment. Oversee the segregation, recovery, and proper handling of impacted or potentially non-compliant materials, especially those requiring legal or regulatory discretion. Gather and interpret quality performance metrics; utilize tools like Oracle to run database queries and generate comprehensive quality reports for internal distribution. Address customer questionnaires and Requests for Proposals (RFPs) accurately and within deadlines; draft and revise quality protocols, SOPs, and procedural documentation. Contribute to internal audits and assist in maintaining the integrity of the Quality Management System (QMS). Required Skills and Competencies: Proficient in the use of MS Office applications (Excel, Access, Word, PowerPoint) and experience with data extraction/reporting tools such as Data Warehouse or Oracle-based platforms. Solid background in data analysis and problem-solving using Lean, Six Sigma, PPI, Minitab, or other process improvement tools. Competency in creating and interpreting various quality tools such as CAPA reports, flow diagrams, Pareto charts, pivot tables, and control/run charts. Minimum of 2 years working within a regulated quality environment—preferably under ISO 13485 and/or FDA cGMP guidelines. Education: Bachelor's Degree or equivalent experience in a technical/scientific field, e.g. engineering, chemistry, biology, or mathematics. Seniority level
Seniority level Associate Employment type
Employment type Contract Job function
Job function Quality Assurance Industries Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Biotechnology Research Referrals increase your chances of interviewing at Infotree Global Solutions by 2x Sign in to set job alerts for “Quality Assurance Specialist” roles.
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Quality Assurance Specialist (Medical Devices)
3 days ago Be among the first 25 applicants Infotree Global Solutions provided pay range
This range is provided by Infotree Global Solutions. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$25.00/hr - $28.00/hr Direct message the job poster from Infotree Global Solutions Technical Recruiter at Infotree Global Solutions(Hiring for USA, UK, Sweden and other Nordic Countries)
Description: We are looking for an experienced Quality Assurance Specialist to manage and support quality systems and compliance processes in a regulated environment. The ideal candidate will bring strong analytical abilities, problem-solving expertise, and hands-on experience with quality management in line with ISO standards and FDA regulations. Key Responsibilities: Collaborate with suppliers to investigate product-related quality concerns and deliver clear communication of root causes and corrective/preventive actions (CAPAs) to customers. Serve as the liaison between internal teams, customers, and suppliers during quality issue resolution, ensuring timely and effective problem management. Process the download and distribution of Complaints daily. Review, validate, and share investigative findings and resolution steps with internal and external stakeholders to maintain transparency and alignment. Oversee the segregation, recovery, and proper handling of impacted or potentially non-compliant materials, especially those requiring legal or regulatory discretion. Gather and interpret quality performance metrics; utilize tools like Oracle to run database queries and generate comprehensive quality reports for internal distribution. Address customer questionnaires and Requests for Proposals (RFPs) accurately and within deadlines; draft and revise quality protocols, SOPs, and procedural documentation. Contribute to internal audits and assist in maintaining the integrity of the Quality Management System (QMS). Required Skills and Competencies: Proficient in the use of MS Office applications (Excel, Access, Word, PowerPoint) and experience with data extraction/reporting tools such as Data Warehouse or Oracle-based platforms. Solid background in data analysis and problem-solving using Lean, Six Sigma, PPI, Minitab, or other process improvement tools. Competency in creating and interpreting various quality tools such as CAPA reports, flow diagrams, Pareto charts, pivot tables, and control/run charts. Minimum of 2 years working within a regulated quality environment—preferably under ISO 13485 and/or FDA cGMP guidelines. Education: Bachelor's Degree or equivalent experience in a technical/scientific field, e.g. engineering, chemistry, biology, or mathematics. Seniority level
Seniority level Associate Employment type
Employment type Contract Job function
Job function Quality Assurance Industries Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Biotechnology Research Referrals increase your chances of interviewing at Infotree Global Solutions by 2x Sign in to set job alerts for “Quality Assurance Specialist” roles.
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr