Job Description Summary

The Quality Engineer II is responsible for applying/interpreting the Quality Systems, technical principles, theories, concepts, techniques, and quality sciences (Microbiology or related) for assigned product and related manufacturing areas. Ensures that activities and documentation remains compliant. This role will primarily support Complaint Handling and Post-Market surveillance activities for the ID/AST plant & associated products; as well as New Product Development (NPD) activities, as applicable. This role provides guidance for the various elements of the Quality System, for example, investigation of product complaints to determine appropriate corrective action plans and effectiveness monitoring. Proven application of the appropriate statistical tools to analyze data, identify root cause and corrective actions for effective problem resolution of moderate to difficult scope and complexity. Preferable experience with pre-market/NPD activities for medical technology products.

Job Description

Primary responsibilities include complaint handling, data mining, investigating, corrective action plans, monitoring, and trending quality indicators.

Developing solutions to routine problems varying in difficulty.  Assessing Critical To Quality (CTQ) parameters and risk assessment variables as part of the decision making processes to support predictable product design and flow.  Initiates CAPAs and may lead the investigation/corrective action process.

Responsible for the various aspects of ID/AST sustaining & NPD Quality Engineering, including routine Quality Engineering responsibilities for assigned products and quality system focus.  Directly responsible to the Plant Quality Manager for the continued consistent implementation/application of Quality Systems as it relates to new and current product lines and Enterprise business systems. Is also responsible for assuring departmental compliance with ISO and FDA requirements through supporting internal and external audits, participation on various cross-functional project teams, assigned project support, product launches, process improvements, and coordination/resolution of CAPAs, Quality notifications, change notifications, and customer complaints.

• Develops, documents, administers, and maintains Quality Systems for conformance to applicable regulatory requirements and company policies
• Provides guidance, updates, and troubleshooting to quality product and processes using technical and enterprise knowledge independently and in team environments
• Uses tools for risk analysis/management, root cause, investigation, validation, and project management, sampling plans, Six Sigma, control plans and design control
• 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
• 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, as well as applicable regulatory requirements
• Supports internal and external audits, and assists in administering the audit program
• Develops and maintains efficient methods for regularly reporting status to management the product quality with respect to Quality objectives and goals, and provides plant quality metrics as required to generate quality system improvements.
• Implement revision to documents 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.
• Ability and skill to effectively manage multiple projects/tasks and drive execution of change management plans
• Ability and skill to lead or manage sustaining projects and continuous improvement projects using statistical technique/tools such as: Statistical sampling, SPC, Six Sigma, additionally Quality tools for 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
• Ability and skill to analyze data using systematic analytical tools such as Six Sigma, root cause analysis, failure analysis and risk assessment to gather critical information that has moderate to difficult complexity
• Proven knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) ISO 13485

• Additional Job Description

Bachelor's degree - typical degree in Biological Sciences, Chemistry, and/or Regulatory Affairs or other related field.

or

Masters degree - typical degree in Biological Sciences, Chemistry, and/or Regulatory Affairs or other related field.

3-5 years for associates with Bachelors Degree, 1-3 years for associates with Masters degree

Primary Work Location

USA MD - Baltimore

Additional Locations

Work Shift