**Job Description Summary** The purpose of this position is to assist Quality Assurance Management in maintaining a department of qualified, motivated, and respected Quality Engineers. This includes assisting all Quality Engineers with the proper tools and guidance to be successful in performing their work, as well as providing them with a work environment conducive to personal and professional success. Additionally, the Senior Quality Engineer functions as a subject-matter resource for Engineering, Operations, Sterilization and outside suppliers. **Job Description** We are **the makers of possible** BD 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. The purpose of this position is to assist Quality Assurance Management in maintaining a department of qualified, motivated, and respected Quality Engineers. This includes assisting all Quality Engineers with the proper tools and guidance to be successful in performing their work, as well as providing them with a work environment conducive to personal and professional success. Additionally, the Senior Quality Engineer functions as a subject-matter resource for Engineering, Operations, Sterilization and outside suppliers. **ESSENTIAL DUTIES AND RESPONSIBILITIES** + Represents the Corporation, Division and Quality Department in a professional manner. + Participates on Project Team as Quality Representative. Ensures that principals of Design Control are applied to Product and Process Changes and New Product Development. + Provides Quality Assurance leadership for Project Teams or Quality Department. + Creates, reviews and approves Quality System Documents (CAPA, Audits) + Creates, reviews and approves Product Documents, such as Design History Files + Creates, reviews, and approves Protocols, Process and Product Validations, Stability Creates, reviews and approves Risk Assessments such as FMEA, FMECA or FTA. + Protocols, Software Validation documents + Mentors staff + Provides supervision to technicians and engineers + Analyzes process and product non-conformances and implement comprehensive corrective and preventive action plans. + Performs Internal or Supplier Quality System Audits. + Ensures compliance to Department and Division procedures. + Participates and has 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. + Performs Complaint review and investigation as required. + Tracks and trends Quality Indicators. + Collaborate with manufacturing facility or other Division Facilities. + Serves as Independent QA Reviewer and Chairperson for Design Reviews. + Other duties, as assigned. **QUALIFICATIONS** To perform this job successful, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this section and below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. **Education and Experience** + B.S/M.S in Engineering, Engineering Technology, or Science. + Minimum 5 years of experience with a B.S in Engineering and FDA-regulated industry, including 3 years of product development experience. + Or minimum 3 years of experience with an M.S in Engineering and FDA-regulated industry, including 2 years of product development experience. **Knowledge, Skills, and Abilities** + **Engineering and Quality Management** : + Ability to perform broad engineering work with minimal direction from Quality Management. Generally, receives guidance on novel or controversial problems. + Ability to understand and implement systemic changes to enhance product quality and improve business efficiency. + Ability to collaborate with regulatory bodies to present technical information. + Ability to interpret regulations, corporate, division, and department procedures. + **Regulatory and Standards Knowledge** : + Extensive knowledge of medical device regulation, industry or international standards, including management responsibility. + Experience interacting with external regulatory bodies (FDA, MDSAP, PMDA, CFDA). + Experience working with notified bodies like BSI, Deckra, and TUV. + Working knowledge of IEC 60601-1, UL2601-1, EM Directive, and other appropriate industry standards. + **Quality Systems and Validation** : + Extensive knowledge of quality systems and their relationship to business. + Experience in writing process, software, and equipment protocols/validations. + Fundamental knowledge of validation principles. + Experience with validating new/special manufacturing processes. + **Statistical and Analytical Skills** : + Understanding of basic applied statistics, statistical sampling plans, statistical process control, and advanced statistical methodologies. + Well-versed in statistics, modeling, optimization, data presentation, and analysis. + Experience with Minitab statistical tool. + **Communication and Interpersonal Skills** : + Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. + Excellent communication skills (verbal, written, and presentation). + Ability to present information effectively to different audience levels. + Ability to write reports, business correspondence, and procedure manuals. + Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. + **Technical and Engineering Principles** : + Complete understanding and wide application of technical principles, theories, and concepts in the field. + Understanding of Fundamentals of Engineering Principles. + **Time Management and Multitasking** : + Ability to effectively manage time and handle multiple task assignments. + Ability to translate quality requirements into product specifications. + **Certifications** : + American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) preferred + **Reasoning and Decision-Making** : + Highly variable operations performed daily from sophisticated regulatory and engineering decisions to routine administrative functions. Interpretation of regulations (GMP, ISO 13485, EN46001) into standards and procedures as required. The ability to explain these interpretations to Plant, Division, Corporate and representatives of Regulatory bodies is necessary. + As a senior engineer, tasks and responsibility are highly complex and very difficult. Considering a few important facts must make judgment for very complex issues; written rules, precedents and policies are available for guiding decisions, but are not always easily attained. Some facts may be difficult to attain and the relationship between facts difficult to establish. There are often instances where quick judgments must be made that can have significant impact to the Company. Individual is looked upon as a decision-resource person, one of high integrity and decision-making skills. + Ability to participate and provide leadership on teams and maintain positive work environment with those teams. Understands team functions, leadership techniques and project management methodologies. + A great deal of work must be initiated through a detailed knowledge and understanding of the job function, the establishment of plans to attain the end goal. There is a great deal of freedom of action, originality and imaginative drive and critical analysis since there is not strict day-to-day supervision. The success of implementation of quality plans is largely dependent upon the person’s ability to recognize the most efficient, cost-effective approach to attaining the desired goal. In many instances, the person will be required to use creativity and imagination in carrying out the job function. This person will be working in a fast-paced, technically challenging environment where drive is essential to success. + Decisions made by this person could have significant regulatory and financial implications. Furthermore, this person’s decisions could have a significant impact on health care practitioners and the welfare of their patients. + **Physical Demands:** + Employee may be required to sit, bend, stoop, use a keyboard, see, talk, and hear. + May occasionally lift objects up to 25 lbs. + Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. **WORK ENVIRONMENT** + This position works in a normal office environment. + The noise level in the work environment is quiet to moderate. + 10% travel is required. + When traveling to clinical sites or hospitals, the work environment will be specific to the area under evaluation. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. 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/careers 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. Required Skills Optional Skills . **Primary Work Location** USA GA - Covington BMD **Additional Locations** **Work Shift** 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.