Senior Sustaining Quality Engineer

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following: Other duties may be assigned from time to time.

Sustaining Engineering

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.

Operations Quality

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.

Process Improvements & Reliability

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

a) Communicate significant issues or developments identified during quality assurance activities and provide recommended improvements.

b) Utilize project management tools and lead and/or participate in kaizen events to carry out improvements to Operations and Sustaining Quality Assurance.

c) Participate in corrective and preventive actions (CAPA)-related activities, including CAPA ownership, if appropriate.

d) Promote a culture of continuous improvement.

2. Support the Production team with all measurement and testing requirements and data analysis.

a) Provide expertise in statistical analytical techniques.

b) Provide fact-based quality analyses.

Other duties may be assigned from time to time.

QUALITY ASSURANCE RESPONSIBILITIES: The individual must comply with the following quality system requirements including, but not limited to:

1. Use only formally approved procedures, records, documents and specifications known as “Control Documents” (e.g., device history records, data collection forms, drawings, procedures, and specifications).

2. Use only properly calibrated and maintained equipment.

3. Immediately bring to attention of the head of the Quality Assurance department any possible deviations from specified Standard Operating Procedures or Work Instructions he or she may notice.

4. Ensure no components, parts, manufacturing materials or products will be released unless they meet all inspection and test criteria.

5. Follow all Standard Operating Procedures and Work Instructions relating to the functions preformed.

6. Ensure all purchasing documents are completed to Work Instructions.

SUPERVISORY RESPONSIBILITIES: The Senior Sustaining Quality Engineer will have no direct reports.