Title:  Quality Engineer, Medical Device Software Development

This role is NOT in the IT (Information Technology) space. 

Who We Are:

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

Job Summary:

In this role, the Senior Software Quality Engineer provides quality leadership, governance, and engineering best practices to medical device software development, testing, and implementation. This is a global role that will oversee multiple concurrent projects to ensure regulatory and quality compliance is maintained throughout the software and product development lifecycle. The incumbent will provide quality leadership for software development projects involving design and coding, verification/validation testing, release, and post-market support. This role will ensure products meet quality standards consistent with internal procedures and acceptance criteria, while meeting all design control and applicable regulatory requirements according to the intended distributed markets. 

They will partner with R&D, Regulatory, and Operations to establish consistency across product platforms, drive software engineering design improvements, and lead implementation of design control related strategies and objectives.  This role will drive harmonization and alignment of West software development methodologies and processes across product platforms, sites, and teams to ensure consistency and state-of-the-art Design History Files. 

The incumbent will be a strong advocate for software quality at all stages of product realization.  Additionally, this role will identify and implement improvements within the Global Enterprise Quality Management System as part of continual improvement and global objectives. 

Essential Duties and Responsibilities:

• Exhibit a strong “quality first” mentality and ensure that software and product quality are held to the highest standard.
• Provide Quality Engineering oversight and direction for multiple concurrent software development programs to ensure software and product compliance to all applicable regulatory and cGMP requirements.
• Provide leadership on the software development process, testing/validation, and compilation of design related technical and engineering documentation.  Partner with R&D teams to implement strategic platform-software development approaches to the product and software development processes.
• Author, review, and/or approve software-related documentation (e.g., strategic planning, requirements, specifications, verification & validation activities, risk management activities, protocols, reports, etc.) 
• Provide quality oversight, review, and approval of software documentation and reports.  Provide direction during technical and design review activities as a Software Quality SME.  Provide Quality oversight of software related verification/validation/design controls activities to other QEs.  Review the quality of work completed with the project team to ensure it meets project standards.
• Lead the development and maintenance of software risk analysis in accordance with West policies and procedures.
• Lead and support software engineering through all stages of the software product lifecycle for medical devices (Design, Verification and Validation Testing, Release, and Post-Market).
• Support cybersecurity team in conducting security review, updating and maintaining security policy and procedure to meet relevant industry standards and regulations (HIPAA, GDPR, HITRUST, etc.)
• Supports internal and third-party audits on the software documentation and development processes.
• Authors and/or reviews reports by collecting, analyzing, and summarizing data; implements corrective actions where necessary as determined by trended data analyses.  Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards
• Drive a harmonized design control program globally within the enterprise with the support of Design Quality leadership.  Author and review product development related QMS procedures and work instructions.  Proactively identify potential gaps and lead projects to resolve them.
• Partner with organizational leaders and drive quality initiatives, systems, and methods to meet quality objectives.  Meet company and departmental goals in the continuous improvement of all products, services and processes, including the West QMS.
• Lead and manage QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, audit findings, issue reviews, etc.  Provide leadership and direct input on any nonconformance, deviation, or excursion that may occur and drive to closure.
• Establish routine communication strategies for project tracking and prioritization
• Drive continuous quality improvement projects
• Other duties as assigned

Basic Qualifications: 

• Minimum, Bachelor's degree in: Computer Science, Software Engineering, or related field.

• Minimum 5 years of experience in software development environment with technical software engineering experiences (design, coding, testing)

• Experience with Software Quality and Risk Management standards in medical devices, such as: IEC 62304, MDR 2017/745, FDA 21 CFR 820, ISO 13485, and ISO 14971.
• Software development or engineering experience with medical device or other regulated field.
• Excellent written, critical reading, and oral communication skills
• Ability to work independently, multi-task and thrive in fast-paced environment
• Strong problem-solving skills including root cause failure analysis methods
• Proficient in statistical software, Windows OS, Microsoft Office: Word, Excel, Power Point, and Teams
• Be aware of all relevant SOPs as per Company policy as they relate to this role
• Able to comply with the company’s safety policy at all times

Preferred Knowledge, Skills and Abilities:

• Experience with development of embedded software of medical devices or custom electronics.
• Experience in conducting medical device security assessments.
• Experience with defect tracking and metrics
• Experience with automated testing tools for continuous integration
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.
• Able to comply with the company’s quality policy at all times.

Travel Requirements:

• Must be able to travel up to 10% of the time

#LI-DJ1

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com.  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.