Job Description SummaryThe Sr. Supplier Quality Compliance Specialist is responsible for providing leadership and guidance to the supplier management programs within the Surgery Business Unit (BU) to ensure compliance to established corporate standards and to regulated agencies for industry (ISO, FDA and others as applicable). Responsible for the planning, development and implementation of quality systems that support the Surgery organization in the successful management of suppliers. This position is key in developing the compliance strategy for Surgery and represents Surgery in the BD Corporate initiatives.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.Essential / Key Job Responsibilities:
Primary Responsibility includes the management of all suppliers providing products/services to the Surgery BU Warwick and Vernon Hills Design Centers. This includes maintaining the Approved Supplier List (ASL), leading the Governance Board and Quarterly Supplier Quality Review Meetings for both Design Centers.
Secondary Responsibility includes providing Supplier Management Oversight of the Surgery BU manufacturing sites to ensure compliance and alignment to regulations and industry standards. Key activities include but not limited to the following:
Review and maintenance of all Quality Agreements
Maintain communication with Regulatory to assure accurate identification of critical and crucial suppliers.
Coordinate the completion of Supplier Surveys/Assessments across Surgery business unit sites.
Work with Procurement/Sourcing during supplier selection to provide quality-related input for potential suppliers.
Monitor status of Supplier Change Requests.
Support supplier audits and improvement projects.
Develop Supplier Annual Monitoring Plan (SAMP) across Surgery business unit sites.
Provide support / actively participate in internal and external audits (FDA, ISO, Corporate, and Internal)
Provide guidance to new product development teams related to supplier capabilities, quality agreement, supplier technical expertise, and overall ability of supplier to meet business needs.
Work with Corporate project teams to coordinate and implement supplier quality initiatives across Surgery business unit sites. Designated as the Surgery BU Encourage Quality Element Business Representative (EBR)for Supplier Management/Purchasing Controls
Provide guidance on documentation associated with supplier qualification and supplier-driven changes including supplier validations, supplier quality agreements, process controls, and compliance to regulations and industry standards.
Periodically assess suppliers and Supplier Quality team practices to ensure global regulatory requirements are met.
Other projects and duties, as assigned
Required Qualifications:
Change Control and Supplier Management experience in a manufacturing environment, preferably in a regulated industry (medical, automotive, aerospace, or similar)
Strong understanding of Root Cause Analysis, Corrective Action, Preventive Action, Efficiency Verification
Strong organizational skills
Strong working knowledge of statistical quality tools and statistical process control (SPC)
Strong oral and written communication skills. Strong interpersonal skills
Preferred Qualifications:
Knowledge of Design of Experiments
Manufacturing background preferred (knowledge of FMEA, Control Plans, Measurement System Analysis (MSA), First Articles, Validation – IQ/OQ/PQ)
Ability to analyze manufacturing and quality systems and provide recommendations for improvement
Familiarity with Production Part Approval Process (PPAP)
Education and/or Experience:
Minimum of a bachelor’s degree in a technical field required ( ie Engineering, Science, etc.).
Minimum of 5 years’ experience in federally regulated industry to include QA, compliance, and/or Regulatory Affairs.
Strong working knowledge of QSR, ISO 13485, MDD/MDR, ISO14971 (Risk Management), and Canadian Medical Device requirements.
Experience conducting quality audits (internal and supplier).
Industry Certification (e.g. ASQ CQE, CRE, CQA, CQM) 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 phenomenal, 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 aim 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 are 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 RI - WarwickAdditional LocationsWork ShiftNA (United States of America)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.
