Description
Responsibilities:* Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
* Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
* Conduct benchmarking to develop more effective methods for improving quality
* Support the implementation of electronic batch records and automated Statistical Process Control software
* Review/analyze whether current product and processes are in compliance to standards such as the QSRs, ISO 13485, etc.
* Partners with Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed.
* Develop measurement systems/capabilities, destructive tests, non-destructive tests for manufacturing processes
* Develop control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.
* Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
* Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
Skills / Knowledge:
Required:
* A minimum of a Bachelors Degree, preferably in Engineering or related technical field. Generally requires 4-6 years related experience.
* Knowledge on Statistical Process Control , Control Plans and FMEAs is required.
* This position will require relevant experience working in manufacturing/operations.
* In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
* Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc.
* Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.
* Previous experience working in a regulated industry, minimum of two years working in an FDA regulated environment.
* Experience in document authoring of validation deliverables.
* Self-directed; ability to work with minimal direct supervision
* Verbal and written communications
* Negotiation
* Problem-solving
* Proactive problem resolution
* Change Management
* In depth knowledge of 21 CFR 820, 21 CFR part11, ISO 13485:2003 and European regulations associated with the medical device industry
* In depth knowledge of GAMP 5 and SDLC process methodologies.