Staff Quality Engineer - United States
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- The Staff 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).
- Applies the appropriate statistical tools to analyze data, identify root cause and corrective actions for effective problem resolution of moderate to difficult scope and complexity. May support both internal and external audits by assuming the Lead Auditor role.
Assesses 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.
- Develops, documents, administers and maintains Quality Systems for conformance, regulatory requirements and company policies.
- Appraises the continuing effectiveness of the quality plan in terms of quality levels, nature of manufacturing quality problems, customer complaints and economical operation. Initiates, implements and/or recommends changes to procedures, policies and specifications when appropriate.
- 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 and design control.
- Extensive application of technical principles, theories, concepts and quality sciences, tools and systems with measureable / confirmed results
- Track record of root cause determination and effective corrective / preventive action implementation
- Supports implementation of corrective actions and improvements by initiating and coordinating SAP data/documentation in current products.
- Drives for continuous improvement in all areas and participates on Continuous Improvement teams and recommends improvements, implements changes and verifies effectiveness of changes.
- Serves as Quality Subject Matter Expert for assigned areas.
- Conducts audits as member of a quality system audit team (e.g. SME, etc.) for both internal and external audits.
- Maintains contacts with vendor quality control representatives as to quality performance and for interpreting standards, specifications, requirements and objectives of the quality plan.
- 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. Keeps management regularly informed on the status and progress made on quality control programs and plans.
- Guides the successful completion of major programs and may function in a project leadership role.
- Ensures quality conduct of projects, including design, data summary and interpretation, report and manuscript preparation and review adherence to applicable regulations
- Decisions, recommendations and results further the achievement of goals critical to organizational objectives
- Implements and communicates the strategic and technical direction for the product/project team
- Identifies any issues that may delay product or project and recommends appropriate action to be taken
- Enhances and promotes the quality organization’s position within the Division by establishing effective interpersonal relationships with all other division functions.
- 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 presentation
- 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
- Ability to drive for results and effectively work through conflicts in working teams by facilitating conflict resolution
- Sound workable knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) ISO 9000:2000 and ISO 13485:2003
- Bachelor's degree with 8 years experience*
- MS with 5 years experience*
- Typical degree in Biological Sciences, Chemistry, and/or Regulatory Affairs or other related field.