Quality Remediation Contractor
Quality Remediation Contractor
Posted on :
25-06-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
Job Summary:
We are seeking experienced Quality Remediation Contractors to support critical remediation activities within a regulated manufacturing environment. Contractors will be responsible for assessing and executing quality remediation tasks including but not limited to rework qualification document revision CAPA support risk assessments and compliance improvements in alignment with applicable regulatory standards (e.g. FDA ISO 13485 GMP).
Key Responsibilities:
Evaluate and qualify product and process reworks in accordance with approved protocols and regulatory requirements.
Review and revise controlled documents (e.g. SOPs work instructions protocols batch records) as part of remediation efforts.
Support impact assessments and risk analysis for nonconformances and historical deviations.
Ensure changes are documented appropriately with traceability and justification aligned to quality standards.
Collaborate with cross-functional teams (Engineering QA Manufacturing) to gather required technical inputs.
Participate in root cause investigations and implement corrective and preventive actions (CAPAs) where applicable.
Maintain accurate records of all remediation activities and ensure timely completion of assigned tasks.
Qualifications:
Bachelors degree in engineering or related field (or equivalent experience).
Minimum of 2 years of experience in quality assurance or quality systems within a regulated industry (e.g. medical devices pharmaceuticals biotech).
Strong understanding of GMP FDA regulations and ISO.
Experience with rework validation document change management and risk-based decision-making.
Proficient in using electronic quality management systems (eQMS) and document control tools.
Excellent attention to detail organizational skills and ability to work independently with minimal supervision.
Languages: Proficient in Spanish and English
* Weil Group is proud to be an Equal Employment Opportunity Employer.*
We are seeking experienced Quality Remediation Contractors to support critical remediation activities within a regulated manufacturing environment. Contractors will be responsible for assessing and executing quality remediation tasks including but not limited to rework qualification document revision CAPA support risk assessments and compliance improvements in alignment with applicable regulatory standards (e.g. FDA ISO 13485 GMP).
Key Responsibilities:
Evaluate and qualify product and process reworks in accordance with approved protocols and regulatory requirements.
Review and revise controlled documents (e.g. SOPs work instructions protocols batch records) as part of remediation efforts.
Support impact assessments and risk analysis for nonconformances and historical deviations.
Ensure changes are documented appropriately with traceability and justification aligned to quality standards.
Collaborate with cross-functional teams (Engineering QA Manufacturing) to gather required technical inputs.
Participate in root cause investigations and implement corrective and preventive actions (CAPAs) where applicable.
Maintain accurate records of all remediation activities and ensure timely completion of assigned tasks.
Qualifications:
Bachelors degree in engineering or related field (or equivalent experience).
Minimum of 2 years of experience in quality assurance or quality systems within a regulated industry (e.g. medical devices pharmaceuticals biotech).
Strong understanding of GMP FDA regulations and ISO.
Experience with rework validation document change management and risk-based decision-making.
Proficient in using electronic quality management systems (eQMS) and document control tools.
Excellent attention to detail organizational skills and ability to work independently with minimal supervision.
Languages: Proficient in Spanish and English
* Weil Group is proud to be an Equal Employment Opportunity Employer.*
Required Experience:
Contract
Employment Type
Contract
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
