This role supports the Detroit Site's commitment to ISO 13485 certification while manufacturing peptones and fine chemicals for bioproduction
Job Summary
This role supports the Detroit Site's commitment to ISO 13485 certification while manufacturing peptones and fine chemicals for bioproduction.
The position is responsible for leading quality compliance activities, managing the internal audit program, and ensuring timely resolution of observations through root cause analysis.
Candidates will drive continual improvement of key QMS elements including change management, document control, and training while supporting production partners for on-time delivery.
Matching Summary
This role supports the Detroit Site's commitment to ISO 13485 certification while manufacturing peptones and fine chemicals for bioproduction.
Skills & Requirements
Must-have
ISO 13485 Quality Management System compliance
Internal audit program leadership
Change management and document control
Root cause analysis and CAPA execution
External audit support and customer inquiries
Nice-to-have
Strong critical thinking and attention to detail
Experience in life sciences industry
Ability to work in matrixed environment
Proven ability to prioritize work effectively
Resourceful with minimal direction required
Key Requirements
Bachelor's Degree required
Minimum 2 years QA experience in ISO 13485 environment
Auditing experience preferred (ASQ CQA or Lead Auditor)
Familiarity with ERPs and electronic document control systems