Process Quality Engineer

**Process Quality Engineer**

**TASKS AND RESPONSIBILITIES**

Quality System:

- In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- Represent Quality by supporting quality disciplines, decisions, and practices.
- Adhere to the Quality Management System. Review/analyze whether current product and processes (including actions or decisions conducted) comply to standards such as FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements, as well as best industry practices.
- Be knowledgeable on QSR and ISO/MDD standards, constantly promoting awareness of applicable Global Regulations and standards, making appropriate decisions on a daily basis.
- Support and prepare for site level internal/external audits and act as Subject Matter Expert (SME) in audits.

In process Quality:

- Provide direct support to ongoing manufacturing of products by identifying and implementing effective process control systems that meet or exceed internal and external requirements, and which are consistent with the level of process/product risk.
- Lead process control and monitoring of CTQ parameters and specifications.
- Develop measurement systems/capabilities, destructive tests, non-destructive tests for manufacturing processes. Develop, interpret, and implement standard and non-standard sampling plans.
- Have the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
- Work closely with Manufacturing and other support functions to troubleshoot during unexpected events.
- Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process controls.
- Conduct evaluations and oversight of production personnel and processes to ensure procedures are being followed in accordance with GMP compliance and regulatory guidelines.
- Participate in Customer Complaints investigations for areas under your control.
- Recommend improvements to the production process to ensure quality control.

New Products and Processes:

- Support the development of quality strategies related to the development of new products, materials and component and the transfer to production through cross functional team collaboration, understanding technical requirements, supporting qualification, and ensuring adherence to the quality system and regulatory requirements.
- Provide guidance with and Review/Approve URS, IQ, OQ, PQ, TMV and/or Software Validation.
- Perform validation activities as needed. Appropriately document experiment plans and results, including protocol writing and reports.
- Summarize analyze and draw conclusions from test results/ process related findings and make appropriate decisions.
- Promote the creation of quality plans due to technology transfer projects, validations and significant changes in the QMS as applicable.
- Establish guidance and maintain Documented Quality Plans to ensure a timely and controlled implementation of product developments, improvement projects and subcontracted manufacturing activities.

Corrective and Preventive action:

- Lead corrective and preventive action (CAPA) projects using root cause analysis as well as identifying and implementing robust solutions.
- Lead the prevention of product and process nonconformances.
- Conduct Risk based decision making and effective resolution of issues.

Process Improvement:

- Continually seek to drive improvements in product and process quality.
- Identify and drive continuous improvement projects and quality initiatives by partnering and communicating effectively with various functions.
- Identify and implement effective process control systems to support the development, qualification, and on going manufacturing of products to meet or exceed internal and external requirements.
- Conduct benchmarking to develop more effective methods for improving quality Pro actively investigates, identifies and implements best in class Quality Engineering practices and implements/manage improvement projects within the organization.
- Assist in the development and execution of streamlined business systems, which effectively identify and resolve quality issues.
- Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
- Use Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality.

Risk Management:

- Document, justify, review, or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential noncompliance to a required standard such as ISO 13485.
- Lead in the completion and maintenance of risk analysis.
- Develop control plans consistent with product classification, p