Job Description Summary

The Staff Quality Engineer is a key member of the New Product Development Team and is responsible for QA-related R&D activities from research through product launch. This position ensures that quality engineering principles are applied to new product development and sustaining engineering projects.

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.

• Responsible for being the core team quality representative for design control projects - new product development as well as sustaining efforts.

• Manage all quality aspects of the design control process: quality planning; verification and validation planning and execution; risk management; regulatory and compliance support.

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

• Work closely with Program Managers to ensure design deliverables are met and can be released to limited commercial and/or general release.

• Works together with Quality Engineers to ensure effective verification of design specifications and requirements.

• Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross functional teams

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

• Lead/own or support CAPA investigations and CAPA closures.

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

• Follow Quality System Regulations and established procedures

• Responsible for assuring departmental compliance with ISO and FDA requirements through supporting internal and external audits, participation on teams, assigned project support, product launches and process improvements, and coordination and resolution of CAPAs, product quality notifications, change notifications and customer complaints.

• Proactively engage partners to drive consensus and resolve issues in a timely fashion.

• Provide statistical support and expertise and analytical problem solving for product

• Acts as a resource for colleagues with less experience.

• Requires a minimum of a BS degree in science, engineering, or relevant subject area

• Minimum 8 years' experience with emphasis on R&D development, Quality Engineering and Design Control

• Proficient in Microsoft Office suite (Excel, Word, PowerPoint).

• Excellent verbal and written communication skills.

• Attentiveness to details with strong organizational skills

• Ability to work independently as well as part of a team.

• Ability to use root cause analysis tools and execute corrective action plans

• Knowledge of quality systems and regulatory standards requirements including 21CFR 820, ISO13485, ISO14971

• Knowledge in lean tools and techniques (Practical Problem Solving, A3, PFMEA and /or Fishbone diagrams)

• Familiarity with GMP and regulatory requirements for medical devices.

• Experience with hardware development within a regulated environment is preferred.

• Thorough understanding of the risk management and quality by design is preferred

• Experience in production and process control is preferred

• Quality Engineering Certification (ASQ) or equivalent is preferred

• Experience in Project / Program Management preferred