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 owns/lead 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.
Owns Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.) and audits (External / Internal)
Responsible for developing and maintaining quality engineering methodologies and providing quality engineering leadership and support for commercialized products, manufacturing, and/or system/services support.
Works with minimum supervision and assignments are broad in nature and employee uses discretion to design project task and to bring the project to completion.
- Verify company’s adherence to the established Quality System and GMP/ISO standards.
- Completion of risk management and risk analysis including FMEA. Also, provide mentorship 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 mentorship to lower level engineering positions.
- Supports technical and statistical investigations concerning optimization and compliance to specification. Also, provide mentorship 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.
- 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 mentorship to lower level engineering positions.
- Executing and authoring IQ, OQ, PQ, and/or PPQ Qualifications and Inspection and Test Method Qualifications. Also, provide mentorship 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 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.
- Lead, coach, and mentor non-exempt and entry level exempt personnel.
- Creating and Communicating details and information of events related to quality to upper management.
- Participation as listener and presenter on management meeting such as QDR, KPIs and Management Review.
- Perform other duties and responsibilities as assigned by senior management.
- Perform supervisor activities to Quality Technicians or Quality Engineers, if required.
- Bachelor Degree in Engineering.
- 5-7 years experience in Quality Engineering positions.
At least 5 years experience, with preferably 3+ years in a quality
- 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 in process improvement tools such as: (Root Cause Analysis,
Fishbone, Is/Is Not, etc.), Six Sigma or Process Control & Monitoring (SPC).
- Detailed knowledge of FDA, GMP, and ISO 13485.
- Experience on product and process qualification and validation.
Project management experience, participating or leading multidepartmental
- Experience on External and Internal audits.
Provide mentorship to lower level engineering positions on Technical
Advance command of English required. Fluent oral and writing
communication including technical writing.
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