BD (Becton, Dickinson and Company) Qualty Engineer II in Mannford, Oklahoma

Job Description Summary

Job Description

Summary

This position is responsible for developing methods to increase productivity, maximize efficiency, and assist with the management of human capital more effectively. This position will be the primary quality contact for the relevant drug handling and combination device manufacturing aspects within the Mannford, OK facility and will be responsible for all quality aspects in regards to compliance to 21 CFR Part 4 and Part 210/211. This position will be a core team member of the respective Product Team providing quality leadership in the development, deployment, and continuous improvements for manufacturing processes. The position will also be the main quality leader for all aspects of the quality management system (CAPA, Complaints, Supplier Management, Nonconforming Product, Environmental Monitoring, etc.) within the product team.

Responsibilities

  • Lead all quality compliance activities for the Mannford facility in regards to the 21 CFR Part 210/211 and Part 4 regulations. This includes (but is not limited to) API drug inspection & storage, drug retains, stability program, temperature monitoring, facility infrastructure, environmental monitoring, and management of laboratory services

  • Act as primary quality contact within the Mannford facility for change control management of all combination devices

  • Work collaboratively with product team leadership to develop and deploy manufacturing and quality goals in support of facility and corporate initiatives

  • Work with product team leadership to drive corrective actions and continuous improvements based on feedback from manufacturing floor issues, customer feedback and audit results

  • Apply statistical methods and perform mathematical calculations to determine manufacturing processes, staff requirements, and production standards

  • Coordinate quality assurance objectives and activities to resolve production problems, maximize product reliability and minimize cost

  • Work with product team leadership on process and continuous improvement efforts providing technical support and direction

  • Partner and assist engineering resources with new equipment and processes with installation and qualification procedures to ensure total process control

  • Evaluate precision and accuracy of production and testing equipment and engineering drawings to formulate continuous improvement plans

  • Prepare test plans and reports (capability studies, qualification and validation) for assigned improvement activities

  • Provide key technical assistance to product team members on writing and executing test approvals and final reports

  • Analyze statistical data and product specifications to determine standards and establish quality and reliability objectives for finished products.

  • Ability to use metrology and statistical methods to diagnose and correct improper quality assurance and control practices

  • Managed the respective quality management system (QMS) for the value stream. The QMS aspects include, but are not limited to, CAPA, complaints, supplier management, environmental monitoring, nonconforming product, and design/change controls.

  • Manage quality line budget for applicable areas as defined by Quality Manager

Qualifications

  • Bachelor of Science in Engineering, Technology, Science or equivalent

  • 3-5 years experience in the quality department of a manufacturing-based organization.

  • 1-3 years experience in process engineering with focus on process improvements and controls

  • Knowledge and demonstrated application of quality methods and tools. This includes but is not limited to 6 Sigma, FMEA, Design of Experiments, Statistical Process Control, Measurement System Analysis

  • Experience working in a regulated environment strongly preferred

  • Strong, comprehensive knowledge of ISO 13485:2003, 21 CFR Part 820 QSRs, 21 CFR Part 4 & Part 210/211, Medical Device Directive, Canadian Medical Device Regulations, JPAL preferred

  • Previous experience in a pharmaceutical manufacturing environment is desirable

  • Flexible and able to function without rigid organizational boundaries

  • Able to successfully work in an open, no-wall work environment

  • Self-confident, highly organized, detail oriented, high energy with excellent time management and planning skills

  • Able to work extended hours in critical situations

  • Excellent written and verbal communication and presentation skills with the ability to articulate ideas and concepts into practical solutions

  • Aptitude for conflict resolution, negotiation and creating positive outcomes

  • Results and Goal oriented – Competitive and driven to succeed with unquestionable integrity

  • Creative and persistent problem solver; excellent analytical and thinking skills with a highly refined work ethic who is able to work independently or as part of a team

  • Demonstrated positive interpersonal skills with a flexibility and adaptability to relate to and collaborate with people at all levels of the organization and work well with a diverse employee group

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

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Primary Work LocationUSA OK - Mannford

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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