Quality Assurance Specialist (QMS Compliance) (ADX-212-19)
QUALITY ASSURANCE SPECIALIST I/II (QMS COMPLIANCE) (ADX-212-19)
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.
POSITION SUMMARY:
The Quality Assurance Specialist (QMS Compliance) will provide support in the quality system area of compliance including internal audit, CAPA, risk assessment and complaints. The Quality Assurance Specialist will report to the QMS Manager/Director.
RESPONSIBILITIES:
- 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
QUALIFICATIONS:
- 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.
EDUCATION:
Bachelor’s Degree (science discipline preferred) or equivalent experience