POSTITION SUMMARY:

The Design Quality Engineer, Assay will serve as a subject matter expert on Archer’s design control project core teams. This position is expected to develop processes, author quality documentation, and disseminate expertise via training, mentoring and core team collaboration. 

RESPONSIBILITIES:

• Own Archer’s CDx design control process by improving upon and executing quality management system documentation. Execution will include collaborating, via review and authorship of documents, with Archer’s core teams development teams in the creation of design quality documentation to support validated product design and submissions to regulatory authorities.
• Act as a facilitator of risk management (ISO14971:2012) as it applies to the creation of a risk management file for the product under development. Utilizing the results of the risk assessment as inputs into the design verification protocols, design validation protocols, supplier stratification and process validations.
• Support core teams in the planning, verification &validation, transfer and product launch.
• Support as an SME for the Design History File during internal and external audits.
• Where appropriate, manage external resources, such as consultants, on key initiatives by demonstrating accountability to management on timelines, costs and execution.
• 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:

• 5 - 10 years in the design or development of regulated class II and/or class III IVD/medical devices.
• Preferred companion diagnostic design control experience for
• Demonstrable experience in medical device risk management, process validation, supplier development.
• Experience in speaking for and defending 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.

EDUCATIZON: