Job Description Summary

The Sr. Quality Engineer has responsibility for applying/interpreting the applicable Quality Systems, developing/implementing the Standard Operating Procedures and policy's for an organization, such as Quality control, or a manufacturing plant. Develops and maintains schedules and timelines. Ensures the documentation process remains compliant.

The role provides guidance for the various elements of the Quality System, for example, to ensure process control, consistent supplier qualification practices and identifies/recommends opportunities for continuous improvement (internal/external). Moderate level of application of the appropriate statistical tools to analyze data, identify root cause and corrective actions for effective problem resolution of moderate scope and complexity. Will support both internal and external audits.

• This specific role will have a focus on site validations of equipment, software and materials.
• Develops, documents, administers and maintains Quality Systems for conformance, regulatory requirements and company policies.
• Provides advice, updates, and troubleshooting to quality product and processes using technical and enterprise knowledge independently and in team environments.
• Uses tools including FMEA, risk analysis, validation, and project management, sampling plans, Six Sigma, control plans, trending and design control.
• Initiates and/or supports CAPAs and may lead the investigation/corrective action process
• Supports implementation of corrective actions and improvements by initiating and coordinating SAP data/documentation in current products.
• Responsible for initiating and coordinating SAP master data and documentation for product changes and new products.
• Responsible for validation activities in support of the Baltimore/Sparks reagent plants.
• Provide support for routine Quality Engineering responsibilities in the ID/AST manufacturing plant.
• Drives for continuous improvement in all areas and participates on Continuous Improvement teams and recommends improvements, implements changes and verifies effectiveness of changes.
• Performs all duties in accordance with all applicable BDDS Quality, Safety and Operating Procedures to support operations day to day.
• Supports internal and external audits and assists in administering the audit program.
• Develops and maintains efficient methods for regularly reporting to management the current status of product quality with respect to Quality objectives and goals and provides plant quality metrics as required to generate quality system improvements.
• Facilitates investigation of customer complaints. Implement revision to TI's based on the result of complaint analysis. Initiates preventative action plans and field action plans in response to valid customer complaints.
• Defines Change Control requirements for the plant related to manufacturing, facility and material changes. May provide full support to raw material changes assuring that all Quality Systems and requirements are met.

• 5 years' experience within the quality function or Master's Degree with minimum of 3 years' experience in quality.

• Experience with independently writing and executing validation protocols
• Experience in a medical device or pharmaceutical manufacturing facility.
• Moderate knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) ISO 13485
• Clinical Diagnostic experience a plus
• Ability and skill to effectively manage multiple tasks and drive execution of change management plans
• Ability and skill to lead or manage process control, supplier quality and continuous improvement projects using statistical technique/tools such as: Statistical sampling, SPC
• Six sigma, additionally root cause analysis and project management techniques are routinely employed
• Ability to effectively write communications that ensures clarity, accuracy and consideration of the audience
• Ability to speak with clarity and express points of view in a variety of settings; one-on-one interactions, group meetings, and formal presentations
• Ability to listen to others; including associates, managers, peers and customers when making decisions and solving problems