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Senior Quality Engineer

Staftonic LLCFort Lauderdale, FL, US

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Job Description

Title : Senior Quality Engineer

Location : Fort Lauderdale, Florida

Long Term Project

Key Responsibilities :

Provide project supervision, leadership, and support in a matrixed team environment.
Review and approve complex technical documentation for compliance with industry standards and regulations.
Conduct gap assessments against industry regulations and standards.
Support regulatory inspections, audits, and remediation activities.
Author, review, and maintain Design History Files (DHF) and Risk Management Files (RMF) for combination products.
Manage and document quality events including CAPAs, Deviations, OOS, Investigations, and Complaints .
Contribute to supply chain / vendor compliance activities and ensure adherence to SOPs and policies.
Provide technical project management and facilitate meetings when required.

Qualifications :

Bachelor’s degree in Biomedical, Mechanical, Chemical Engineering, or related science / engineering discipline.

Minimum 7+ years of experience in pharmaceutical, biotechnology, medical device, or combination product development / manufacturing.

Strong knowledge of ISO 13485 and FDA QMSR .

Hands-on experience with risk management tools and data analysis applications .

Preferred experience with combination products such as pre-filled syringes, autoinjectors, co-packaged kits, or other drug delivery systems.

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Senior Quality Engineer • Fort Lauderdale, FL, US

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