Careers

Quality Engineer

 

Job Description:

Work with other departments to ensure quality of combination products (medical device with drug) and drug delivery product processes. May be responsible for generating risk analysis documents, performing validations, supporting in-house manufacturing, investigating quality issues or product complaints, performing quality audits, or developing new procedures/methods.

Responsibilities Include:

• Participate on drug delivery product project teams as the quality representative.
• Interface with R&D to ensure that drug delivery products are designed for patient safety in terms of FMEA, risk analysis, toxicology, Quality System compliance, and manufacturability.
• Support activities related to drug delivery product development, validation, process validation, and in-house manufacturing.
• Investigate current or potential quality issues and implement corrective/preventive actions.
• Perform operational, laboratory, and product complaint investigations.
• Coordinate calibration activities.
• Develop and implement Quality System policies and procedures.
• Perform internal audits and supplier audits.
• Perform other quality engineering duties as assigned.

Qualification Requirements:

• Excellent organizational skills and attention to detail.
• Strong communication skills.
• Computer literacy, proficiency in MS Office, Excel, PowerPoint etc.
• Ability to provide scientific judgment.
• General knowledge of statistics (i.e. sampling plans).
• Understanding of drug cGMPs.
• Experience working in clean room preferred.
• Bachelor’s degree in an engineering or other relevant scientific discipline.
• 2-5 years in pharmaceutical or related work experience.

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