Quality Assurance Training Manager (ADX-311-20)

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 Training Manager will be responsible for cultivating and managing a compliant and effective training program for ArcherDX’s employees. While Quality Management System (QMS) effectiveness will be of primary concern, this position will facilitate and curate any training that will engender strong fundamental understanding of operating in a regulated IVD environment. The scope of training as contemplated by the position is limited to internal employee training, and is not intended to reflect any training for customers or other field activities.

RESPONSIBILITIES:

• Curate training curriculum for functional roles to ensure competency for their duties under the QMS.
• Gather content from functional subject matter experts where necessary for appropriately detailed training.
• Develop and support a process for tailoring training rigor to the nature of the relevant QMS mechanism, such as trainings on process updates or when training is used as part of corrective and preventive action plan.
• Maintain a functioning eTraining tool and associated records.
• Present ArcherDX’s training program in audits and inspections, while fielding relevant questions therein.
• Lead effective IVD/medical device awareness and education, even when outside the scope of QMS mandates, in circumstances including, but not limited to, on-boarding, annual refreshers, and new/changing industry requirements.
• Accept and drive ad hoc training efforts and programs when assigned.
• Collaborate with Human Resources, Communications and other teams when training programs expand beyond IVD and medical device product development matters.
• Contribute training metrics, success and challenges to Quality department performance tracking, such Quarterly Management Reviews, dashboards, and other mechanisms.
• Manage a team of Quality Assurance staff to ensure sharp record-keeping, prompt employee support, and continuity of ArcherDX’s training program.

EXPERIENCE: 

• 7 or more years supporting and/or operating in a role governed by a medical device or IVD QMS.
• 3 or more years of experience developing and delivering training content and/or programs.
• 1 or more years of experience managing staff in a regulated environment.
• High degree of proficiency with document and presentation creation.
• A passion for training and education, including a creative drive for employee education with a focus on continuous improvement.
• Familiarity medical device and/or IVD design control and QMS processes.
• Experience with good manufacturing practice (cGMP) and good document practice.
• Fine research skills with a knack for sketching out solutions to novel issues
• Ability to interact with multiple disciplines and communicate clearly and effectively verbally and in writing.
• Ability to work independently and report progress efficiently.
• Ability to multitask and work within a fast-paced dynamic team environment

EDUCATION:

• Minimum B.S./B.A, preferably in a technical field.