BD (Becton, Dickinson and Company) Senior Quality Engineer - Design in Sparks, Maryland
Job Description SummaryThe Senior 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, R&D 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.
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.
Supports new product development and product maintenance in the Molecular plant through the application of Quality engineering skills.
Must be able to handle multiple projects and tasks, from product inception through product launch and maintenance.
Plays an active role in the processes to ensure products meet quality standards consistent with both Corporate and division policies, while meeting all design control and other regulatory requirements.
Represents the Quality Function on GPDS Core Teams and Continuous Improvement project teams for both New Product Development and Manufacturing.
Accountable for Design History Files/Change Control, Risk Management, development of QC methods, stability, reliability and process validation.
Supports Quality System implementation and compliance.
Responsible for functional representation on project core team(s) and extended team(s). This will include, QMRC planning for project schedules and resources, GPDS QMRC plans (Quality Management, Labeling, Stability and Reliability) to achieve project-specific deliverables and other GPDS or Design Control Deliverables as determined by the project.
Responsible for Project Risk Management.
Responsible for developing and maintaining project-specific Design History File.
Knowledge and Skill:
Ability and skill to effectively manage multiple tasks and drive execution of change management plans
Drive for results and effectively work through conflicts in working teams by facilitating conflict resolution
Manage multiple projects simultaneously.
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
Write communications that ensures clarity, accuracy and consideration of the audience
Speak with clarity and express points of view in a variety of settings; one-on-one interactions, group meetings, and formal presentations
Listen to others; including associates, managers, peers and customers when making decisions and solving problems
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
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
Professional certification preferred. Six Sigma, ASQ, AAMI, valuation (hiring manager identifies preference)
Experienced in Microsoft Office suite skills. Basic mini tab and/or related analytical software programs
Certification such as ASQ-CQA/CQE, AAMI, AOAC, Six Sigma or a Company certification such as Green Belt, Black Belt, IGQA auditor preferred.
Associate’s degree with 8 years experience in a regulated environment or:
Bachelor’s degree with 5 years experience in a regulated environment or:
MS with 3 years experience
Typical degree in Biological Sciences, Chemistry, Engineering, Computer Science and/or Regulatory Affairs or other related field.
- Experience in a Quality or Research and Development function preferred.
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