Quality Remediation Consultant

Dorado, Puerto Rico, Puerto Rico
Contracted
Technical Services Division
Experienced
We are seeking experienced Quality Remediation Consultant to support critical remediation activities within a regulated manufacturing environment. Consultants 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:
  • Bachelor’s 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

"Drug Free Workplace Policy: In accordance with our commitment to maintaining a safe and productive work environment, all applicants for employment with our company are required to affirm their commitment to a drug-free workplace and consent to pre-employment drug testing as a condition of employment."

Share Tech Group is committed to being an equal opportunity employer, fostering a diverse and inclusive workplace where all individuals are treated with respect and provided with equal opportunities for employment and advancement.

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