Supplier Quality Assurance Manager (ADX-206-19)
Supplier Quality Assurance Manager (ADX-206-19)
COMPANY OVERVIEW:
ArcherDX, headquartered in Boulder, CO, is committed to the advancement of personalized medicine by making next-generation sequencing technology more reliable and accessible. We seek like-minded individuals who share our values of curiosity, passion and grit to meet these goals.
Make it happen by joining us in the fight against cancer.
POSITION SUMMARY:
The Supplier Quality Assurance Manager will implement, manage and administer the Supplier Quality Management Program (SQMP)
REPORTING STRUCTURE:
The Supplier Quality Assurance Manager position reports to the Director of Manufacturing Quality Engineering.
RESPONSIBILITIES:
- Manage and administer the SQMP
- Assess and implement improvements to the SQMP as needed
- Develop and manage the supplier audit schedule
- Implement quality agreements with suppliers
- Perform and/or arrange for performance of supplier audits
- Manage supplier related Nonconformance reports, Corrective and Preventive Actions reports
- Manage supplier change management
- Monitor and report supplier performance using meaningful metrics
- Act as a subject matter expert for the SQMP in customer and regulatory audits.
- Manage the document archiving and retrieving process.
- Assist or lead problem-solving activities.
- Maintain compliance with all company policies, quality systems, procedures, and ISO and GMP requirements.
- Work with cross-functional teams in problem-solving
- Assist in collecting and evaluating data to support quality metrics
- Perform other duties as assigned by supervisor
QUALIFICATIONS:
- Minimum of eight (8) years experience in a regulated industry
- Minimum of three (3) years in Supplier Quality Management
- Previous audit experience preferred
- Attention to detail with an ability to follow directions
- 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.
- Ability to travel up to 20%
EDUCATION:
Bachelor’s Degree (science discipline preferred) or equivalent experience