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Senior Quality Engineer
Staftonic LLCFort Lauderdale, FL, United States10 days ago
Job type
- Full-time
Job descriptionBachelor’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.
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 :
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Senior Quality Engineer • Fort Lauderdale, FL, United States