Job Description

Key Responsibilities:

• Conduct root cause analysis and implement corrective and preventive actions (CAPAs) for process deviations and non-conformances.
• Collaborate with cross-functional teams, including manufacturing, R&D, and regulatory affairs, to enhance product quality and process efficiency.
• Participate in risk management activities, such as Failure Modes and Effects Analysis (FMEA) for equipment and tooling.
• Support complaint investigations by analyzing lot history records and manufacturing processes.
• Support the development and execution of manufacturing change implementation plans.
• Ensure adherence to FDA, ISO 13485, and other relevant regulatory and quality system requirements.
• Document and analyze quality data to drive process improvements and operational excellence.

Must Have: Minimum Qualifications

• Bachelor’s Degree in Biomedical Engineering, Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or related field.

Nice to Have: Preferred Qualifications

• Internship or co-op experience in a medical device, pharmaceutical, or manufacturing environment.
• Knowledge of Six Sigma, Lean Manufacturing, and process improvement methodologies.
• Experience with Good Manufacturing Practices (GMP) and regulatory compliance.
• Strong analytical and problem-solving skills.
• Ability to work collaboratively in a team environment.
• Basic knowledge of quality systems, statistical analysis, and process validation.
• Effective communication skills for documentation, reporting, and cross-functional collaboration.

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