**_MAIN PURPOSE OF ROLE_**
Works closely with Manufacturing and Engineering on sustaining activities to ensure compliance with the quality system requirements and achievement of Key Performance Indicators (i.e.
NCMR's, MA's, Yield, Cost Reduction projects, etc.)
and support/owns process/product validation activities.
Works closely with Research and Development and Regulatory Affairs personnel (internal or external) to obtained support on sustaining activities and during new product introduction to assure compliance with product and regulatory requirements.
Support of Major Quality System investigations (i.e.
CAPAs, HHEs, StopShip, etc.)
and audits (External / Internal).
**_
MAIN RESPONSIBILITIES_**
- Verify company's adherence to the established Quality System and GMP/ISO standards.
- Completion of risk management and risk analysis including FMEA.
- Work with R&D/Design Quality to revise design verification and design validation plans for products based on performance specifications and risk analysis.
- Conducts technical and statistical investigations concerning optimization and compliance to specification.
- Owner of measuring process capability, process controls, and process validation / efforts.
- Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities
- Conducting NCMR Investigations, Calibration Out Of Tolerance (OOT) Investigations and Complaint Investigations (MA) related to manufacturing Process
- Completing and Documenting Monthly Quality Data Review, providing data analysis and escalation recommendations with minimum mentorship from higher level engineering.
- Leading Build At Risk (BAR) Authorizations & Closures
- Completion and approval of document Change Requests, assuring accuracy, adequacy, and compliance to Quality System and product requirements
- Creation and maintenance of Quality Plans and Reports, typically with minor mentorship from higher level engineering.
- Executing and authoring IQ, OQ, PQ, and/or PPQ Qualifications and Inspection and Test Method Qualifications, typically with minimum mentorship from higher level engineering.
- Conducting Advanced Statistical Data Analyses using Minitab with minimum mentorship from higher level engineering.
- Authoring Master Validation Plans and Reports
- Support/owns Major Quality System investigations (i.e.
CAPAs, HHEs, StopShip, etc.)
with minimum mentorship from higher level engineering.
- Supports activities during preparation and execution of audits (External / Internal)
- Perform supervisor activities to Quality Technicians, if required.
**_
QUALIFICATIONS_**
- Bachelor Degree in Engineering
- 2 - 4 years experience in Quality or Engineering positions.- Knowledge of statistical/data analysis and report writing experience.
- Experience working on FDA, GMP, and ISO 13485 Regulated environments.
- Experience in process improvement tools such as: Root Cause Analysis, Fishbone, Is/Is Not, Six Sigma or Process Control & Monitoring (SPC), Quality Tools.
- Experience with control of nonconforming material, corrective and preventive actions as investigation owner and/or implementer.
- Knowledge on product and process qualification and validation.
- Intermediate command of English required.
Capable of maintain fluent oral communication face to face or by conference