Sr. Design Quality Engineer, Product Software and IT Infrastructure

POSITION SUMMARY:

The Senior Design Quality Engineer, Software Product and IT Infrastructure  will serve as a subject matter expert on Archer’s software design lifecycle, non-product software tool documentation and data privacy compliance.  This position is expected to develop processes, author quality documentation, and disseminate expertise via training, mentoring and core team collaboration.

RESPONSIBILITIES:

• Own Archer’s software design lifecycle process by improving upon and executing quality management system documentation. Execution will include collaborating, via review and authorship of documents, with Archer’s software development teams in the creation of software documentation to support validated software design and submissions to regulatory authorities.
• Act as lead facilitator of software risk management, cybersecurity design considerations and development of software design inputs. Integrate results with project level design quality efforts.
• Drive planning, improvement and execution of IT and data architecture on an enterprise level. Identify key stakeholders among Archer’s IT, data management and clinical teams and lead a program of continuous improvement and compliance in terms of data integrity, audit readiness, privacy (HIPAA, GDPR, etc.), business continuity and disaster recovery.
• Support Archer software, production, and data management teams in the development, validation, and documentation of non-product software tools which facilitate the manufacture, testing and maintenance of Archer’s product an processes.
• Where appropriate, manage external resources, such as consultants, on key initiatives by demonstrating accountability to management on timelines, costs and execution.
• Increase Archer’s overall expertise in the development of high quality and compliant software product and tools by acting as a trainer and mentor to cross-functional audiences.
• Assess project and infrastructure needs to create and execute and organizational plan to ensure proper support for all of Archer’s product and infrastructure obligations.
• Support diligence audits, as a subject matter expert, by pharmaceutical partners (potential and current) as well as quality and regulatory authorities. When assigned findings for closure, demonstrate accountability and a commitment to continuous improvement by resolving issues in a timely manner.
• Perform other duties as assigned by supervisor

QUALIFICATIONS:

• Minimum of 7 years in the design or development of regulated software with 3 or more years of experience in software quality assurance and/or software tool validation.
• Demonstrable experience in medical device risk management, process validation, GDPR, HIPAA, and cybersecurity requirements.
• Strong technical writing skills with hands-on experience authoring, peer-reviewing and defending software documentation for product, data infrastructure and non-product tools.
• Experience in speaking for and defending software design and validation documentation to external auditing authorities.
• Certifications, such as ASQ, in quality assurance preferred.
• Ability to interact with multiple disciplines, and communicate clearly and effectively verbally and in writing.
• Ability to work independently, and utilize good problem-solving skills.
• Ability to multitask and work within a fast-paced dynamic team environment. Archer is interested in a subject matter expert who will build collaboration among key departments rather than define functional boundaries.

EDUCATION:

• Minimum B.A. or B.S., preferably in software engineering or other technical discipline