Quality Assurance Specialist (QMS Compliance) (ADX-212-19) 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 enhance 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.
- Provide support for the creation and maintenance of quality management systems documentation compliant to ISO13485:2016.
- Implement and maintain the quality system area for internal audits.
- Help facilitate risk assessment compliant to ISO14971:2012
- Assist with management of deviations, non-conformances and CAPA
- Identify improvements by analyzing the current business/system processes and recommending improvements within the scope of the Quality Management System.
- Maintain compliance with all company policies, quality systems, procedures, and ISO and GMP requirements.
- Work with cross-functional teams in problem-solving, project completion and system improvements.
- Assist in collecting and evaluating data to support quality metrics, as applicable to the Training system area.
- Identifies improvements by analyzing the current business/system processes and recommending improvements within the scope of their focus area(s)
- Maintain compliance with all company policies, quality systems, procedures and ISO and GMP requirements.
- Ability to work with cross-functional teams in problem solving.
- Assist in collecting and evaluating data to support quality metrics.
- Review, understanding, and compliance with ArcherDX HIPAA Security policies and procedures.
- Safeguarding the privacy and security of protected health information and European Union personal data.
- Processing and handling of European Union personal data only as directed by ArcherDX for purposes of personalized molecular pathology.
- Perform other duties as assigned by supervisor
- 1-3 years experience in a quality role in a FDA-regulated environment (Level 1)
- 3-5 years experience in a quality role in a FDA-regulated environment (Level 2)
- Knowledge of ISO and GMP
- Medical Device experience preferred
- Attention to detail with an ability to follow directions for creating quality system records.
- Ability to interact with multiple disciplines, and communicate clearly and effectively verbally and in writing.
- Ability to work with minimal direction, and utilize good problem-solving skills.
- Excellent planning and organization skills.
- Effective analytical skills.