Senior Quality Engineer, Software

Senior Quality Engineer, Software

Hybrid

USA CA - San Diego TC Bldg C&D

Full time

R-506618

Job Description Summary

The Sr. 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 design controls and risk management principles are applied to new product development and sustaining engineering projects.

This position also supports broader QMS activities (Gap analysis & remediation, Audit, CAPA, Data Analysis, Complaint Handling, etc.).

We have an immediate opening for a highly motivated, results-focused professional to join our team, and are growing our staff as a Sr. Quality Engineer. The Quality Engineer's primary responsibilities are to support new product development activities, maintain compliance to company procedures and external standards, manage design history files, review design artifacts, participate in risk analysis activities, collaborate on product development deliverable documentation, support failure investigations, identify system issues, summarize findings and prepare reports for key quality metrics.

Please note this role is in the Quality organization and has no direct responsibility for software testing (V&V).

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.

Business & Product Overview: 

Pyxis® medication technologies combine proven technology with actionable intelligence to prevent medication errors, help free up caregiver time to focus on patient care, increase the predictability of medication availability, and reduce inefficiencies in the med use process.

At almost every point in the med use process, safety and efficiency can be increased with the comprehensive capabilities of the Pyxis® medication management system.

Broader Duties for this role include: 

• 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.

• Actively reviews design artifacts to ensure compliance with QMS and good documentation practices prior to final approval

• Drive continuous improvements in QMS activities as it relates to software development lifecycle including post market through facilitating, leading, and collaborating with cross functional teams

• Work closely with program managers to ensure design deliverables are met and products can be commercially released in defined markets.

• Identify gaps & improvement opportunities to ensure effective verification and validation of design specifications and requirements.

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

• Works collaboratively to drive root cause analysis of failures, CAPA and use structured problem solving for product development and manufacturing issues.

• Support internal and external audit activities as it pertains to software quality processes

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

​What is expected of you for success in your role:

• Demonstrates strong knowledge of quality engineering policies, principles and best practices

• Understanding of regulatory and international standards requirements including 21 CFR 820, ISO 13485, ISO 14971 and IEC 62304 to support quality engineering activities

• Applies comprehensive knowledge of software quality concepts within the software development lifecycle

• Identify risks and proactively work with the program team to document risks and help to develop and ensure mitigation plans are in place

• Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc…)

• Applies knowledge and skills to a wide range of situations

Desired Characteristics:

• Software development experience within a regulated environment

• Strong background in software development methodologies

• Prior experience with supporting external audits with FDA, BSI, TUV etc

• Experience working in an iterative development environment like Scaled Agile Framework (SAFe) esp SAFe Certifications

• Thorough understanding of the risk management and quality by design

• ASQ Certified Software Quality Engineering Certification (CSQE) or equivalent

• Attentiveness to details with strong organizational skills

• Ability to work proactively and independently

• Ability to manage multiple priorities and be efficient in time management

• Excellent verbal communication and interpersonal skills with the ability to work in a team environment

• Proficiency in Excel, Word, and other desktop/general business systems

Qualifications: 

• Qualified candidates will have a bachelor’s degree in a relevant degree field (engineering) 

• Minimum 3 years’ experience with emphasis on R&D development, Quality Engineering and Design Controls 

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.