Senior Sustaining Quality Engineer

Description

SUMMARY:

The Senior Sustaining Quality Engineer is responsible for ensuring compliance with internal and external requirements for post-market products, their respective manufacturing processes, and the quality programs that support these products. The Senior Sustaining Quality Engineer is responsible for supporting the sustainment of manufacturing, product reliability and process repeatability alongside Operations Engineering. This position supports the continuous improvement of manufacturing processes and of the Quality Systems that support production.

The Senior Sustaining Quality Engineer is responsible for ensuring that documented practices meet the true interpretation of the Quality Management System standards by overseeing the testing, monitoring, and inspecting processes of the Business. The position is responsible for providing engineering support to operations to ensure consistent application of quality techniques, determining quality improvement parameters, monitoring production quality, the Master Validation Plan, the sterilization validation program, investigation of manufacturing issues & non-conformances, and developing test procedures in support of the Business.

Other duties may be assigned from time to time.

• 1. Supports Change Management Program coordinating with change management project managers to ensure appropriate assessment of changes and timely execution of project deliverables.
• 2. Support efforts to update technical documentation, product specifications, process quality plans, validations, biological evaluations, etc. for post-market products via the Change Management Program in response to internal changes, supply-chain, or external customer or regulatory requirement updates.
  • a) The scheduling and timely completion of periodic validation assessments
  • b) The execution of validation assessments based on changes
  • c) A comprehensive listing of all validations and verifications is maintained and keep up to date

Other duties may be assigned from time to time.

• 1. Responsible for the released product/process performance conformance to established processes.
• 2. Own the Master Validation Plan and ensure:
  • a) The scheduling and timely completion of periodic validation assessments
  • b) The execution of validation assessments based on changes
  • c) A comprehensive listing of all validations and verifications is maintained and keep up to date
• 3. Participate in the design and execution of initial validation/verification activities to support production equipment, processes, and test methods as well as subsequent revalidation/reverification where required.
• 4. Lead the Sterilization Program and ensure its compliance to applicable standards
  • a) Responsible for periodic bioburden testing and review
  • b) Periodic Sterilization method requalification
  • c) Master product assessments
• 5. Regularly monitor the production process to ensure quality;
  Monitor production to assure processes are being followed; provide inputs on inspection methods & improvements.
• 6. Collect relevant data from various related sources and analyze to effectively monitor and ensure quality outputs.
• 7. Maintain statistical process controls and develop sampling plans to ensure processes are in-control.
• 8. Develop test procedures and test proposed components for product improvements / substitution.
• 9. Analyze data by completing hypothesis, normal distribution, and process capability analysis tests.
• 10. Develop metrics to monitor trends and present data to facilitate quality, risk-based decision making.

• 1. Participate in continuous improvement of manufacturing processes and quality programs supporting…