Job Description Summary

Lead a team of Quality Engineers responsible for supporting software and systems projects for medical devices.

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.

We have an immediate opening for a highly motivated, results-focused professional to join our team as a Senior Quality Engineering Manager - Software. The Quality Engineering Manager's primary responsibilities manage Quality Engineers to support new product development activities, maintain compliance to company procedures and external standards, manage design history files, create verification and validation documentation, participate in risk analysis activities, collaborate on product development deliverable documentation, identify system issues, summarize findings and prepare reports for key quality metrics. Responsibilities also include being the quality and compliance representative in the assigned teams.

Accountabilities

• Manage, mentor, and develop Quality Engineers on approach to design controls, agile design, risk management and product security.

• Build strong partnerships with cross-functional leaders to drive continuous improvement efforts, through facilitating, leading, and collaborating effectively.

• Manage and monitor day to day activities to ensure compliance with company policies and procedures (e.g. compliance with BD QMS, FDA and equivalent medical device regulations, internationally harmonized consensus standards, etc.).

• Quality support of US and international activities.

• Manage quality metrics and present them in management reviews.

• Responsible to assigned or being the prime quality representative for design control projects – new product development as well as sustaining efforts.

• When applicable, responsible for review and/or approval of design history file documentation in support of design controls.

• Manage all quality aspects of the design control process: quality planning; requirements generation and traceability, code reviews, integration testing, verification and validation planning and execution; risk management; regulatory, compliance and product security support.

• Lead the defect tracking process and management of issues prior to release and any issues that may present from the post-market surveillance teams.

• Quality representative in risk management activities including approval of risk management reports and risk analyses.

• When applicable, work closely with Program Management to ensure design deliverables are met and can be released to limited commercial and/or general release.

• Works together with SW Quality Engineers and R&D Leaders to ensure effective verification of design specifications and/or requirements.

• Review effectiveness of assessments of DHFs and Change Orders and/or Electronic Release Authorizations for new releases or design enhancements.

• Active participant in the development of product requirement, product system hazard analysis and design reviews.

• Work closely with Product Management and UX teams to ensure effective validation of user needs.

• Ensure product technical files and Design History Files are complete, traceable and auditable.

• Provide clarification and guidance to teams on overall quality system with emphasis in design controls.

• Provides decisions, recommendations, and results to further the achievement of goals critical to organizational objectives.

• Identifies areas requiring quality improvement and initiates and follows through plans of action (Quality Plans) necessary for implementation.

• Responsible to provide Quality support in 510k or International submissions a