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Manufacturing Engineer

4 weeks ago

Grand Rapids, United States Novozen Healthcare LLC Full time

Job Title: Packaging Engineer


Key Responsibilities:

  • Develop and execute remediation plans to address non-compliance issues related to packaging processes.
  • Collaborate with cross-functional teams to create detailed action plans and timelines for remediation.
  • Ensure timely and effective implementation of remediation efforts to meet regulatory requirements.
  • Lead and execute action plans for process controls to maintain packaging quality and consistency.
  • Implement monitoring systems to track process parameters and detect deviations.
  • Conduct training sessions for staff on new or updated process controls.
  • Continuously assess the effectiveness of process controls and make improvements as needed.
  • Update documentation for all packaging processes within PLM systems, ensuring accuracy and compliance.
  • Maintain correct records of changes, updates, and versions of packaging documentation.
  • Support labeling system improvement projects by assisting in the design and implementation of enhanced labeling systems.
  • Collaborate with IT and quality teams to improve labeling software and data management systems.
  • Develop and implement procedures for labeling that ensure accuracy and regulatory compliance.

Skills and Qualifications:

  • Strong understanding of manufacturing processes, particularly in relation to packaging.
  • Experience in designing and optimizing line layouts for packaging processes.
  • Proven experience in developing and validating packaging processes for efficiency and compliance.
  • Knowledge of CAPA processes for addressing and preventing quality issues.
  • Ability to conduct thorough root cause analysis and implement corrective actions.
  • Proficiency in identifying root causes of process issues and developing practical solutions.
  • Experience with Gemba walks to observe and improve packaging processes.
  • Commitment to continuous improvement through Lean, Six Sigma, or other quality methodologies.
  • Six Sigma certification (Green Belt or Black Belt) is preferred.
  • In-depth understanding of packaging and labeling requirements specific to medical devices.
  • Familiarity with regulatory standards such as FDA and ISO for medical device packaging.
  • Knowledge of global packaging regulations, including ISO, FDA, and other relevant standards.
  • Experience in ensuring packaging processes and documentation meet regulatory requirements.

Educational Requirements:

  • Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Manufacturing Engineering, or a related field.
  • Advanced degrees or certifications in related fields are a plus.

Experience Requirements:

  • years of experience in packaging engineering, preferably in the medical device industry.
  • Experience in working with PLM systems and quality management systems is highly desirable.