Quality Validation Engineer
Job Title:
Quality Validation EngineerLocation:
Cambridge, MA
Experience:
7 to 9 yearsJob Type:
Full-time, On-siteCompany Description:
We are a leading healthcare solutions provider dedicated to improving patient outcomes through cutting-edge GxP digital solutions. Our commitment to quality and compliance drives our mission to deliver innovative products and services to our healthcare clients.Position Overview:
We are seeking an experienced Quality Validation Engineer to join our dynamic team in Cambridge, MA. The ideal candidate will have 7 to 9 years of experience in quality assurance and validation within the healthcare industry, with expertise in CAPA, QA assurance, quality control, and GMP quality standards. Knowledge of GxP digital solutions and experience with Veeva Quality Management System (QMS) will be considered a significant advantage.Key
Responsibilities:
Develop and execute validation protocols and reports for GxP digital solutions in compliance with regulatory requirements. Perform risk assessments and impact analyses related to validation activities. Lead and participate in cross-functional teams to ensure quality and compliance throughout the product lifecycle. Manage CAPA processes, including investigation, root cause analysis, corrective action implementation, and effectiveness verification. Conduct quality assurance activities to ensure adherence to GMP quality standards and regulatory guidelines. Collaborate with internal stakeholders and healthcare clients to address quality-related issues and drive continuous improvement initiatives. Maintain accurate documentation and records related to validation activities and quality assurance processes.
Qualifications:
Bachelor's degree in a relevant scientific or engineering discipline. 7 to 9 years of experience in quality validation and assurance within the healthcare industry. Strong understanding of CAPA processes, QA assurance principles, and quality control methodologies. Experience with GxP digital solutions and Veeva QMS is highly desirable. Thorough knowledge of GMP quality standards and regulatory requirements. Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams. Detail-oriented mindset with a focus on accuracy and compliance. Ability to work independently and manage multiple tasks in a fast-paced environment. Additional Information:
This position is 100% on-site in Cambridge, MA. One round of interviews has been completed. How to Apply:
If you meet the qualifications outlined above and are passionate about quality and compliance in healthcare, we encourage you to apply by submitting your resume and cover letter to Recommended Skills Attention To Detail Business Process Improvement Communication Quality Management Regulatory Requirements Research Apply to this job. Think you're the perfect candidate? Apply on company site $('.external-apply-email-saved').on('click', function (event) window.ExternalApply = window.open('/interstitial?jobdid=j3w782602lr2c4xgh6j', 'ExternalApply-j3w782602lr2c4xgh6j'); ); $(document).ready( function() $(#ads-desktop-placeholder).html(
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n Estimated Salary: $20 to $28 per hour based on qualifications.
Quality Validation EngineerLocation:
Cambridge, MA
Experience:
7 to 9 yearsJob Type:
Full-time, On-siteCompany Description:
We are a leading healthcare solutions provider dedicated to improving patient outcomes through cutting-edge GxP digital solutions. Our commitment to quality and compliance drives our mission to deliver innovative products and services to our healthcare clients.Position Overview:
We are seeking an experienced Quality Validation Engineer to join our dynamic team in Cambridge, MA. The ideal candidate will have 7 to 9 years of experience in quality assurance and validation within the healthcare industry, with expertise in CAPA, QA assurance, quality control, and GMP quality standards. Knowledge of GxP digital solutions and experience with Veeva Quality Management System (QMS) will be considered a significant advantage.Key
Responsibilities:
Develop and execute validation protocols and reports for GxP digital solutions in compliance with regulatory requirements. Perform risk assessments and impact analyses related to validation activities. Lead and participate in cross-functional teams to ensure quality and compliance throughout the product lifecycle. Manage CAPA processes, including investigation, root cause analysis, corrective action implementation, and effectiveness verification. Conduct quality assurance activities to ensure adherence to GMP quality standards and regulatory guidelines. Collaborate with internal stakeholders and healthcare clients to address quality-related issues and drive continuous improvement initiatives. Maintain accurate documentation and records related to validation activities and quality assurance processes.
Qualifications:
Bachelor's degree in a relevant scientific or engineering discipline. 7 to 9 years of experience in quality validation and assurance within the healthcare industry. Strong understanding of CAPA processes, QA assurance principles, and quality control methodologies. Experience with GxP digital solutions and Veeva QMS is highly desirable. Thorough knowledge of GMP quality standards and regulatory requirements. Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams. Detail-oriented mindset with a focus on accuracy and compliance. Ability to work independently and manage multiple tasks in a fast-paced environment. Additional Information:
This position is 100% on-site in Cambridge, MA. One round of interviews has been completed. How to Apply:
If you meet the qualifications outlined above and are passionate about quality and compliance in healthcare, we encourage you to apply by submitting your resume and cover letter to Recommended Skills Attention To Detail Business Process Improvement Communication Quality Management Regulatory Requirements Research Apply to this job. Think you're the perfect candidate? Apply on company site $('.external-apply-email-saved').on('click', function (event) window.ExternalApply = window.open('/interstitial?jobdid=j3w782602lr2c4xgh6j', 'ExternalApply-j3w782602lr2c4xgh6j'); ); $(document).ready( function() $(#ads-desktop-placeholder).html(
n
n
n Estimated Salary: $20 to $28 per hour based on qualifications.
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