Quality Assurance Specialist
6 days ago
Location: Remote
Duration: 06 Months (Temp to Hire)
We are seeking a Quality Engineer II to join our team at Aditi Consulting.
Key Responsibilities:
- Ensure timely and efficient complaint investigations and documentation.
- Evaluate and escalate relevant information on product complaints to management.
- Coordinate meetings with departments for customer complaint issues.
- Plan and execute onboarding training for new complaint associates.
- Assess, process, and close complaints in accordance with procedures and customer quality expectations.
- Maintain and organize complaint product retention programs.
- Author and conduct technical complaint evaluations and investigations.
- Review quality and manufacturing records.
- Perform trending and risk analysis of received complaint investigations.
- Establish and maintain Quality Management System procedures.
- Support internal and external audits.
- Ensure compliance with ISO 13485, MDD, 21 CFR 820, GMP, and other applicable regulations.
- Provide Complaints data analysis for metric reviews.
- Support post-market surveillance activities.
- Identify and implement opportunities for continuous improvement.
Requirements:
- Bachelor's degree in an Engineering discipline (e.g., Mechanical, Electrical, etc.) with 2-5 years' experience in a regulated industry.
- Strong knowledge of FDA Quality Systems Regulations, GMP, ISO 13485, and other global regulations.
- Strong verbal and written communication skills.
- Demonstrated organizational skills with the ability to multitask, prioritize, and meet deadlines.
- Ability to read and write in English.
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