Job Description Summary
The Associate Director EMI (Electromechanical Instrumentation) Quality Excellence reports to the Vice President of Quality EMI. This role is responsible for developing and maintaining quality assurance programs, policies and procedures for EMI. It will work across BUs and Central Quality to align process and procedures for the EMI site. This role will also focus on driving manufacturing quality issues to completion and developing dashboards for reporting out on overall EMI quality performance.
The Associate Director EMI Quality Excellence will be responsible for ensuring the appropriate Quality agreements are in place as the EMI strategy is implemented. It will also be responsible for oversight of Quality BD Excellence initiative across the EMI sites and will be responsible of implementation of dashboards to track metrics and performance of the EMI sites. Quality System team members report directly to the Associate Director and are under their authority for performance reviews, career development, compensation, hiring, and termination. The Associate Director also partners with manufacturing, supply chain and procurement leaders, operating with independence to strengthen and improve EMI management and governance under the oversight of the Vice President, Quality Management, EMI.
The role will have responsibility for providing leadership and support for Continuous Improvement programs through use of Six Sigma (Manufacturing, Transactional and Design for Six Sigma), Lean, Validation, CI tools and project management best practices.
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.
Key Responsibilities
Manages the various quality programs for the EMI Hub. These include CAPA, NCR, Internal Audits, Quality Certificates, Training, Calibration, Customer Quality Agreements, Customer Complaints, Analysis of Data, Design & Development, etc.
Collaborates with cross functional partners such as Quality Engineering, R&D, Operations, Medical, Marketing to seek their input into the development of policies and procedures, and their support in addressing Quality Issues.
Actively participated in external regulatory inspections and audits. Ensures that pre and post-inspection activities are completed including scheduling, record review, training, logistics, etc. Prepares responses to audit nonconformities for review by senior management. Assists with FDA and external audit readiness at BD sites.
Ensures the CAPA Program is established and maintained.
Ensures that the training program is effectively implemented, and that appropriate training is assigned, provided and monitored to ensure Business training compliance goals are met.
Establish and maintain processes to analyze Quality Data from the EMI Sites.
Assist with the preparation for EMI Management Review.
Provide guidance and training to the Device sites in various quality system areas such as CAPA, Internal audits, Analysis of Quality Data, Complaint Management, etc.
Supports company initiatives aimed at improving and standardizing the Quality Systems processes. RepresentsEMI in Quality Networks (such as CAPA, Training, Quality Notification, Customer Complaints etc.).
Collaborates with the Unit/Site Quality EMI Leaders to seek their input and support in implementing the Network objectives at the EMI sites.
Establishes and Implements worldwide policies and procedures aimed at harmonizing the Quality Systems at EMI Sites worldwide.
Manages and coordinates the Quality Systems staff. Carries out Human Resource management responsibilities such as hires, job assignments, coaching, termination recommendations, promotions, salary actions, and processes performance reviews on time.
Responsible for planning, developing, and executing CI blitzes in conjunction with other functions and the sites.
Develop and maintain an influential and effective network and communication with peers and leadership team members for identifying improvement opportunities to evaluate, propose and implement new processes and technologies to optimize efficiencies.
Establishes measuring and tracking mechanisms that record measurable results of CI in terms of process efficiency, customer satisfaction, financial and non-financial benefits, and transfers those mechanisms to the functions.
Benchmarks internal and external organizations. Develops and maintains an overall dashboard to track CI program/project progress and develops other communication mechanisms.
Benchmarks internal and external organizations. Identifies, implements, leverages, teaches, and transfers best practice knowledge to and through the organization. Assists functions in utilization of best practices (Manufacturing Six Sigma, Design for SS, Lean, CI Tools).
Identifies, implements, leverages, and transfers best practice knowledge to the EMI organization.
Effectively navigate and lead through the challenges of change and establish key stakeholder engagement focused on win-win solutions.
Continuously evaluate progress toward objectives adapting them to meet customer and business needs.
Other assignments as directed by the Vice PresidentQuality Management EMI .
Education
Bachelor's degree in a technical field required.Engineering degree strongly preferred. Master's degree in a technical field preferred.
Experiences
Minimum of ten (5) years' experience in the following areas: Electromechanical Instrumentation, Quality Assurance/Control, Statistical analysis, FDA QSR's (21 CFR Part 820), lean manufacturing, risk management (ISO 14971), and ISO/EC (MDD/MDR, IVDD/IVDR, MDSAP, CMDR, ISO 13485, J-PAL) requirements.
Required Knowledge and Skills
Knowledge and application of ISO 13485, 21CFR820 and 21 CFR 210-211, MDD/MDR, IVDD/IVDR, requirements and European/US GMPs related to medical device and pharmaceutical manufacture.
Experienced in project management.
Experience in Continuous improvement/Lean Manufacturing principles
Organisational / motivational skills.
Capable of managing a range of projects and activities in parallel.
The ability to manage by influence in addition to functional responsibility.
The preparation, planning and presentation of key initiatives.
The ability to coordinate effectively across regions.
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
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Primary Work Location
USA PA - Zelienople
Additional Locations
USA CA - San Diego Bldg A&B, USA NC - Durham - Roche Drive
Work Shift
At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You (https://jobs.bd.com/benefits) .
Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.
Salary Range Information
$154,400.00 - $254,800.00 USD Annual
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.
