Job Description Summary

Job Description

Reporting to the Sr. Quality Manager, the Staff Quality Engineer I will be a member of the BD Integrated Diagnostics Solutions (IDS) Quality organization and is accountable for providing quality oversight for supplier-related Quality System elements and activities, as well as supporting product development and maintenance through the application of Quality Engineering skills for medical devices.  This person will handle multiple projects and tasks, from product inception through product launch and maintenance, and play an active role in the process to ensure products meet quality standards consistent with both Corporate and Unit policies, while meeting all design control and other regulatory requirements.  The position requires a self-motivated, self-directed individual utilizing a high level of written and oral communication skills.

Primary Responsibilities:

• Provide quality oversight for new supplier qualification/approval and ongoing supplier management, including coordination/completion of supplier audits/assessments

• Lead and oversee supplier related CAPAs/SCARs, Customer Complaint / Quality Notification investigations on supplied products

• Monitor and communicate directly with BD Suppliers as part of ongoing change control projects, supplier quality management/improvement, and quality issue resolution

• Coordinate with Procurement with regards to supplier management activities and ongoing quality performance for BD suppliers.

• Serve as a product development and/or sustaining project team member, working closely with multiple functions and manufacturing sites to establish quality requirements and provide guidance to project teams.

• Support the following activities as part of supplier change control projects to ensure compliance with applicable BD processes: Design Control (Design Verification/Validation, Input/Output documentation creation/updates, etc.), Risk Management review/updates, Test method validation, Process Validation.

• Support BDX initiatives around supplier quality improvement and act as liaison to IDS manufacturing sites.

• Assist BD sites/regions as part of ongoing supplier quality management activities and continuous improvement projects.

• Provide training to BD functions/employees, as needed, with regards to requirements for supplier qualification and management procedures.

• Identify and lead continuous improvement projects related to supplier quality/management processes

• Develop monitoring systems and action plans related to supplier data to maintain quality of products received by BD.

• Collect, interpret, and analyze data and presents to others (including Leadership) either orally or in writing.

• Support and participate in internal and external audits of BD with regards to Supplier Quality/Management processes

• Support Post Market Surveillance activities, as needed, related to finished good products.

• Support Incoming Inspection activities for finished good products, as applicable.

• Use disciplined problem-solving skills to diagnose and prevent/solve product quality issues.

• Consistent application of technical principles, theories, concepts, and quality sciences / tools.

Qualifications:

• Bachelor’s Degree in Science, Engineering or other relevant discipline.

• A minimum of 8 years relevant experience or a combination of equivalent education and experience.

• Medical device experience, preferably in a high-volume manufacturing environment

• Experience leading root cause investigation projects (CAPAs, Complaints, etc.).  Demonstrated problem-solving skills utilizing various root cause analysis tools/processes. 

• Knowledge and application of Design Control requirements with regards to product development in the medical device industry

• Extensive knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g. - 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, EU MDR/IVDR)

• Experience performing quality data analysis and statistics (Sampling Plans, SPC/Control Charts, Pareto Charts, Capability Analysis).

• Demonstrated project management skills with ability to independently handle/prioritize multiple projects and drive to successful outcomes.

• Ability to identify and implement continuous improvement opportunities with regards to processes/procedures.

• Strong oral and written communication skills with ability to communicate and present to various levels of Plant, Division, and Supplier Personnel

• Strong interpersonal skills with ability to work effectively globally with various individuals/functions/locations

• Experience working with remote teams and external suppliers.

• Certified Quality Auditor (CQA) (preferred)

• Six Sigma, Lean, 8D certification a plus.

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.

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