BD (Becton, Dickinson and Company) Quality Engineer II in Sparks, Maryland
Job Description Summary
The Quality Engineer II 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. May support both internal and external audits by assuming the Lead Auditor role.
Responsibilities include monitoring and trending quality indicators for purchased materials as well as manufactured and distributed components/products. 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.
Knowledgeable in specific automated systems as noted and engaged in new product introductions as a possible Core Team member representing the Quality function.
Responsible for the various aspects of Media QM Engineering as well as the day to day QM Engineering responsibilities for assigned product and related operational areas. 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 teams, assigned project support, product launches and process improvements, and coordination and resolution of CAPAs, product quality notifications, change notifications and customer complaints. This includes using Enterprise tools to ensure compliance and streamline processes.
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 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.
Serves as Quality expert for assigned Media product line.
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 IT'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.
Bachelor's degree. Typical degree in Biological Sciences, Chemistry, and/or Regulatory Affairs or other related field.
2+ years experience in Quality, Quality Control, or Quality related complaint handling.
PREFERRED AND ADDITIONAL SKILLS AND QUALIFICATIONS
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 9000:2000 and ISO 13485:2003
Liquid Media and/or Tuberculosis experience is 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, SPCSix 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
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
Primary Work LocationUSA MD - Baltimore
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status