Senior Risk Management Design Quality (ADX-29-20) at ArcherDX
THE COMPANY: ArcherDX, Inc. - www.ArcherDX.com
ArcherDX is advancing molecular diagnostics with a robust technology platform for genetic mutation detection by next-generation sequencing. By combining patented Anchored Multiplex PCR (AMP™) chemistry in an easy-to-use, lyophilized format and powerful bioinformatics software, the Archer® platform enhances genetic mutation identification. ArcherDX provides oncology-focused research products and is pursuing regulatory approval for multiple companion diagnostic assays. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn.
- As part of design & development, the person in this role will need to be hands on working with FTA, PHA, uFMEA, dFMEA, sFMEA, pFMEA and cybersecurity risk assessments. Risk management will also need to be performed as part of post market monitoring in support of complaint risk analysis, field corrective actions, design changes, maintenance efforts, non-product software risk assessments, supplier risk assessment evaluation and manufacturing non-conforming materials. This person will need to be well versed with medical device FDA and EU regulations, and all the necessary steps for risk management documentation.
- Longer term improvement opportunities for the organization will be to centralize and improve the risk analysis documentation and completion efficiency such as selecting, deploying and configuring risk management tools.
- This person will need to develop clinical knowledge in IVD assay systems and supporting medical device software used to perform clinical analysis. These efforts will require leading and applying a consistent approach to hazardous situations, harm identification and risk estimation in order to ensure uniformity within each project life cycle. These may entail working with clinical experts, external business partners, and chief medical officers.
- Daily tasks for this role will be based around risk management documentation, risk analysis, failure mode effects and analysis, authoring risk controls and traceability mapping for identified risk controls including their verification of effectiveness, risk based V&V methods and post market software maintenance, residual risk review and risk benefit analysis. Product DHF risk management files shall be organized in order to support successful regulatory submission when working with the regulatory teams for FDA and EU submission.
- Partner with other functions in the organization to ensure stakeholders requirements are addressed, provide consistent communication with cross functional teams and encourage a spirit of risk management collaboration throughout the organization. Applies flexible and novel approach to solve problems or optimize solutions in complex or cross functional product development and manufacturing.
- Support risk management audits, as a subject matter expert, when working with external business partners and regulatory authorities. When assigned findings for closure, demonstrate accountability and a commitment to continuous improvement by resolving issues.
- Perform other duties as assigned by supervisor
- Minimum of 5 years in supporting risk management used in a regulated industry with desired experience in performing software risk assessment. Good technical writing skills with hands-on experience authoring, peer-reviewing and defending risk management documentation.
- Ability to speak and defend risk management 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.
- Design quality risk management subject matter expert in the implementation and compliance with 21 CFR 820.30 ISO 14971, ISO 13485.
- Desired experience and knowledge with IEC 62304, MDR, IVDR, TIR57, FDA cybersecurity guidance, HIPAA, GDPR.
- Minimum B.A. or B.S., preferably in engineering or other technical discipline