Description
* Work with cross-functional teams (including supplier resources) to drive continuous improvement, root cause and final resolution of supplier related opportunities or issues.* Partners with Supplier Quality Engineers in execution of Supplier Process Change Notification requests that are a result of recovery activities including assessing risk, leading re-qualification efforts, and providing information to regulatory.
* Execute characterization plans and reports to assure supplier processes meet specified capabilities, requirements, performance, reliability and safety goals as a result of change/continuity/improvement activities
* Lead technical initiatives to establish stability, implement continuous improvement, and establish lean operating systems at suppliers.
* Drives improvement to internal processes to streamline management of supplier related projects and overall supply chain effectiveness. May provide leadership for these processes and associated cross-functional teams.
* Develop technical solutions to problems using corrective/preventative action processes such as DMAIC and Six Sigma.
* Provides input to technology, development core teams, and sourcing with recommendations affecting Design for Reliability & Manufacturability and supplier selection decisions (technical rigor evaluations at the supply base).
* Execute Supplier Process Assessments to identify risk to the business and will work proactively to mitigate that risk.
* Establish effective control plans, process-monitoring, -capability, and -control at for critical to quality characteristics within the supplier process in order to improve quality and lessen reliance on incoming inspection.
* Ensure personal understanding of all quality policy/system items that are personally applicable. Follow all work/quality procedures to ensure quality system compliance and high quality work.
Basic Qualifications:
* BS Engineering
* 7+ experience with BS and 5+ yrs with product or process manufacturing experience or 3+ yrs experience with MS and 1+ yrs with product or process manufacturing experience
* Supplier experience
* Project management experience
* Quality experience
Desired/Preferred Qualifications:
* Bachelor's Science degree in Engineering, Physics, Materials, Industrial Technology or other equivalent technical degree
* Experience in medical device industry
* Strong performance in Coaching and Mentoring
* Proven ability to work cross functionally and cross business
* Experience in medical device industry
* Strong performance in Coaching and Mentoring
* Proven ability to work cross functionally and cross business
* Good technical writing skills
* Working knowledge of statistical data analysis and related statistical tools
* Six Sigma black or green belt
* Knowledge of regulatory environments (i.e.: ISO, FDA-GMP, etc.) or equivalent