Quality Engineer Job at Planet Pharma, Billerica, MA

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  • Planet Pharma
  • Billerica, MA

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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