Genomics QA Specialist I-II (ISO 13485)

Watchmaker Genomics, Inc.

Colorado

On-site

USD 75,000 - 85,000

Full time

6 days ago

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Benefits offered by this job

Flexible time off

Holidays

Medical plan 75% covered

Dental coverage

Vision coverage

Life/AD&D policy

Job summary

Watchmaker Genomics, Inc. is seeking a Quality Assurance Specialist I-II to join the Quality team in Boulder, CO. This onsite role reports to the Manager of Quality Assurance and supports change control, CAPA, audit readiness, and continuous improvement while ensuring product quality and regulatory compliance.

The role collaborates with production partners and cross-functional teams globally. A Bachelor’s in a related field plus 5–7 years of QA experience is expected; partial remote work is

Qualifications

Bachelor’s degree or higher in molecular biology or related field; 5–7 years quality experience in industry.
Experience with NC, CAPA, root cause investigations, audits.
Strong written and verbal communication; cross-functional collaboration.
Experience with ISO 13485, ISO 9001, or cGMP preferred.

Responsibilities

Support QA change control, NC and CAPA management.
Review and approve quality documents and batch records.
Support external and supplier audits.
Lead improvement projects from NC/CAPA/audits.
Prepare routine QMS metrics and management reviews.

Skills

Communication

Cross-functional teamwork

Independent work

Problem solving

Attention to detail

Multitasking

Growth mindset

Self-motivation

Education

Bachelor’s degree in molecular biology

Job description

The role collaborates with production partners and cross-functional teams globally. A Bachelor’s in a related field plus 5–7 years of QA experience is expected; partial remote work is

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