BD (Becton, Dickinson and Company) Sr. Manager Quality Engineering in Covington, Georgia
Job Description Summary
This position provides Quality Engineering and Quality Assurance technical expertise and functional leadership in support of the Acute Care Franchise for all aspects of the Product Life Cycle.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Represent the Corporation, Division and Quality Department in a professional manner.
Manage and ensure proper implementation of all Quality Engineering duties and responsibilities. Hire, train, develop, review, and manage exempt and/or non-exempt employees as assigned.
Provide Quality Engineering leadership for New Product Development (NPD), Sustaining Engineering (SE) and transfer to manufacturing.
Provide Quality Engineering technical support to assist in resolving quality issues, including but not limited to complaint review and investigation.
Prepare and implement divisional policies relating to quality, project management, product/process development, and design control regulations, etc.
Participate on project teams as the Quality Representative. Ensure that principals of Design Control are applied to Product and Process Changes and New Product Development.
Provide technical support for Franchise Project Teams and the Quality Department.
Create, review and approve Quality System Documents.
Create, review and approve Product Documents for products purchased, manufactured and/or distributed by BD UCC.
Create, review and approve Protocols, Process and Product Validations, Stability Protocols etc. to support the Design History File (DHF)
Analyze process and product non-conformances and implement comprehensive corrective and preventive action plans (CAPA).
Lead efforts to identify, investigate, and create plans to respond to potential product issues involving distributed porduct.
Perform Internal and Supplier Quality Audits.
Ensure compliance to Corporate, Division and Department procedures.
Participate and have membership in trade and/or professional organizations to ensure that state-of-the-art industry standards are communicated into the division in an efficient, timely, and accurate manner.
Provide technical support for complaint and adverse event review and investigation.
Develop Quality indicators for new product launches and assure complaint metrics are monitored post launch. Communicate complaint metrics back to the product development teams as part of awareness and continuous improvement.
Interface with manufacturing facilities or other Division Facilities as required.
Serve as an Independent QA Reviewer for Design Reviews, Design History File Audits (DHFA) and data integrity audits
Participate in worldwide business travel as required by the above duties and responsibilities.
Lead Quality Engineers on the team to execute their duties including:
Lead in identification of device specific regulatory and performance standards that should be used in the formulation of the design input requirements.
Review and approve design input requirements.
Review and approve the translation of design input requirements into design output documents.
Lead in Development of Risk Management Documentations.
Review and approve design verification and validation protocols and reports to demonstrate that the design output fulfills the design input requirements.
Review and approve design verification and validation reports.
Support supplier validations.
Develop and approve test plan for demonstrating conformance to specifications and establishing controls.
Prepare and execute Reliability protocols and report.
Review and approve IQ, OQ, and PQ protocols and final reports.
Review and approve Test Methods.
Lead in post launch quality review.
Manage the Master Validation Plan (MVP) for projects.
Strong Verbal and written communication skills and presentation skills.
Technical writing skills.
Management skills .
Knowledge and understanding of Document Control practices.
Extensive knowledge of medical device regulation, industry or international standard, including management responsibility. Ability to understand Division and Plant Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency. Ability to interface with regulatory bodies to present technical information.
Comprehensive knowledge of quality systems and relationship to business.
Experience in writing protocols/validations and fundamental knowledge of validation principles.
Understanding of applied statistics, statistical sampling plans, and statistical process control.
Ability to serve in leadership roles on projects or assignments.
Comprehensive understanding of auditing principles and ability to perform as a lead auditor.
Ability to participate and provide leadership on teams and maintain positive work environment with those teams. Understanding of team functions, leadership techniques and project management methodologies.
Broad knowledge of manufacturing processes.
Ability to effectively manage time.
Ability to handle multiple task assignments.
Primary Work Location
USA GA - Covington BMD
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, or any other protected status.