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Sr. Quality Assurance Specialist - New Product DevelopmentApply Now Job ID R-19786 Date posted 09/13/2017
Job Description SummaryThe Senior Quality Engineer will be responsible for ensuring that quality standards and objectives are consistent with corporate policies, government regulations, international standards and standards of the medical device industry as applicable. The associate will also ensure that continuous improvement in the R&D setting is pursued on an ongoing and proactive basis.
The position will primarily work with Research & Development and ensure compliance to protocols and procedures and with Regulatory Affairs to ensure the integrity of data being submitted to regulatory agencies. The position requires the ability to handle multiple projects and tasks utilizing a high level of written and oral communication skills. Good reasoning and judgment skills are necessary to ensure the appropriate balance of quality, compliance, and business needs.
- Review R&D related documentation for compliance to applicable procedures, protocols, and requirements. Reviewed documentation includes, but is not limited to, Laboratory Notebooks, stability protocols, data, reports and verification and validation protocols, data, and reports.
- Perform audits of all R&D related areas and training files to evaluate compliance to applicable procedures.
- Ensure that R&D documentation, laboratories, and personnel are in a constant state of audit readiness.
- Identify opportunities for improvement based on the compliance of laboratory areas and quality of R&D documentation. Lead continuous improvement projects, develop, and implement plans for continuous improvement projects using project management techniques.
- Analyze data to proactively identify emerging and systematic issues and/or problems.
- Lead internal investigations and implement corrective and preventive actions.
- Lead department programs / processes on continuous improvement and standardization across the business segment
- Responsible for assuring that R&D work is performed per regulatory requirements including 21CFR 820, ISO 13485, ISO 14971, MOD 93/42/EEC.
- Train others on compliance to R&D related procedures
- Exhibit an excellent attention to detail with a high degree of accuracy and the ability to work independently and in team situations.
- Demonstrate the ability to make critical decisions regarding quality system compliance, then assess, and articulate risk when evaluating a situation.
- Participate on core teams or extended core teams as the QA representative, as needed.
- Interact with the Regulatory Affairs team in reviewing and evaluating submissions to regulatory agencies.
- Bachelor's degree in mechanical engineering or software engineering, biology, molecular biology, chemistry, pharmaceutical sciences, or closely related scientific discipline.
- 5 years of experience in Quality
- Experience in Design Control
- Master's degree in Scientific field with 3 years of experience in Quality.
- Engineering, Software and /or Molecular Biology background preferred
- Experience in research environment preferred
- Experience in the medical device industry preferred
Additional Qualifications and Experience:
- Excellent verbal and written communication, organization, and prioritization abilities; displays sound judgment, problem-solving, interpersonal and analytical skills
- Ability and skill to effectively manage multiple tasks and participate in the execution of change management plans.
- Ability and skill to lead/participate in the Quality function for design projects, reliability concepts for complex systems, validation planning and execution and continuous improvement projects using statistical sampling, six sigma root cause analysis tools and project management techniques
- 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 lead and analyze using systematic analysis tools that include Six Sigma, root cause, failure analysis, and risk assessment to gather critical information for development of a corrective and/or preventive action plans
- Good understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO)
- Ability to interface professionally with internal and external auditors
- Proficiency with Microsoft Office Suite products in a business environment (MS Word, Excel, PowerPoint, and Project)
- Working knowledge of statistical techniques and use of various data analysis programs (e.g. Minitab)
- Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), and/or Six Sigma Green Belt Preferred
- Class III (PMA) medical device experience preferred
Primary Work LocationUSA NC - Durham (Tripath Oncology)
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