REQUIRED QUALIFICATIONS

• Bachelor’s Degree in STEM careers. Engineer preferred.
• 4-6 experience in Quality or Engineering positions.
• At least 4 years of experience in Quality or Manufacturing Engineering positions.
• Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint).
• Knowledge of statistical/data analysis and report writing experience.
• Experience with control of nonconforming material, corrective and preventive actions as investigation owner and/or implementor.
• 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.
• Project management experience, participating or leading multi-departmental project teams.
• Fluent oral and writing communication including technical writing.

PREFERRED QUALIFICATIONS

• Experience with SAP.
• ASQ CQE / Six Sigma or similar certification.
• Participation or leading multi-departmental project teams.
• Experience in supervision role.
• Master’s Degree on position related field.

• Verify company’s adherence to the established Quality System and GMP/ISO standards.
• Completion of risk management and risk analysis including FMEA. Also, provide support to lower level
• engineering positions.
• Work with R&D/Design Quality to revise design verification and design validation plans for products based on performance specifications and risk analysis. Also, provide support to lower level engineering positions.
• Supports technical and statistical investigations concerning optimization and compliance to specification. Also,
• provide support to lower level engineering positions.
• 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.
• Works closely with Sr quality engineering position on completing and documenting Monthly Quality Data Review,
• providing data analysis and escalation recommendations.
• 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. Also, provide support to lower level engineering positions.
• Executing and authoring IQ, OQ, PQ, and/or PPQ Qualifications and Inspection and Test Method Qualifications, Also, provide support to lower level engineering positions.
• Conducting Advanced Statistical Data Analyses using Minitab.
• Authoring Master Validation Plans and Reports.
• Supports activities during preparation and execution of audits (External / Internal), functioning as SME backup for specific Quality activities.
• Support Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.)
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues