Job Description SummaryThis position provides Quality Engineering and Quality Assurance technical expertise and functional leadership in support of the Endourology Platform 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.QUALIFICATIONS: Strong Verbal and written communication skills and presentation skills. Technical writing skills. Management skills. Computer 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.EDUCATION and/or EXPERIENCE: Four (4) year Engineering or Science degree. Eight (8) + years experience in a decision-making quality engineering position or equivalent quality related experience with at least 2 years in FDA Regulated Industry. American Society of Quality (ASQ) Certified Quality Engineer or Certified Quality Manager desired Six Sigma Black Belt training desiredLANGUAGE SKILLS:English required.MATHEMATICAL SKILLS: College level mathematical skills. Basic applied Statistics, statistical sampling plans, statistical process control, DOE, Taguchi Methodology. Reliability tools Able to take theoretical mathematics and apply to business problems.REASONING ABILITY:Complexity: Highly variable operations performed daily, from complex regulatory and engineering decisions to routine administrative functions. This position involves reviewing and making decisions involving Personnel, Statistics, Engineering, document Control, Policy, Procedure, Specifications, Quality Acceptance, Product Development, and Regulatory Compliance issues.Judgement: The position involves making decision involving all areas mentioned above. In some instances, there are written policies or procedures that have to be interpreted. In some instances, only judgment based on past experience can be used.PHYSICAL DEMANDS:The physical demands as required to perform the essential functions of this job are those of a basic office environment and ability to travel as needed. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.WORK ENVIRONMENT:The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Office environment Manufacturing environments May include visits to clinical sites or hospitals.Job DescriptionWe are the makers of possibleBD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.Job Summary:This position will be responsible for managing all aspects of quality within our manufacturing operations in Covington, Georgia. This includes supporting product development projects to meet business objectives, ensuring compliance with internal and external regulations and standards, and maintaining high levels of customer satisfaction. The incumbent must have experience in medical device industry, understanding of ISO requirements, strong leadership skills, and ability to work effectively across multiple functions.Responsibilities:Manage all aspects of quality within our manufacturing operations including but not limited to:
Ensure products are designed to meet customer needs and expectations by participating in design reviews and other project activities; ensure effective product/process transfer into production
Conduct risk assessments as needed to identify potential issues prior to implementation
Develop inspection methods and sampling plans according to established procedures or in consultation with applicable departments such as engineering, manufacturing, purchasing etc.; provide training on these topics as required
Lead audits conducted by customers or regulatory agencies such as FDA, MDD, CE Mark etc.; ensure appropriate documentation and follow up actions are completed
Review nonconformances (NCs), complaints and corrective action reports generated during production or post market surveillance activities; determine root cause analysis and corrective/preventative action plan where necessary
Monitor performance metrics such as scrap rates, defect per million opportunities (DPMO), process capability index (CPK) etc.; implement improvements based on trends identified
Investigate product failures and adverse events associated with our products through review of available data sources including but not limited to complaint files, product liability claims etc.; report findings internally and externally when appropriate
Support customer service organization in resolving product-related questions from healthcare professionals or patients
Coordinate rework activities related to NCs or other quality issues; ensure timely completion of Rework Notifications (RNs) and Corrective Action Reports (CARs)
Oversee maintenance programs for equipment used in manufacturing processes
Provide input on new technology evaluations which may affect current operations
Qualifications:
Bachelor’s degree in engineering, science or related field required
5+ years of experience working in quality management role in medical device industry preferred
Understanding of ISO requirements such as ISO 13485 preferred
Strong leadership skills, organizational abilities, problem solving techniques and interpersonal skills
Ability to work independently and manage multiple tasks simultaneously
Proficiency with Microsoft Office suite applications (Excel, Word, PowerPoint)
Experience with SAP software system preferred
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.Why Join Us?A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.To learn more about BD visit https://bd.com/careersBecton, 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.Primary Work LocationUSA GA - Covington BMDAdditional LocationsWork ShiftBecton, 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.
