Position Summary
Experienced Quality Assurance professional with 5-7 years in the medical device industry, focused on audit response, CAPA, validation, and document control within ISO 13485-compliant environments.
Duties and Responsibilities
- Prepare and maintain the quality system in a state of audit readiness.
- Lead internal preparation and documentation support for regulatory, customer, and certification audits (e.g., ISO 13485/cGMP/MDSAP/IVDR/WHO PQ).
- Respond to auditor inquiries and ensure timely resolution of findings.
- Manage the full lifecycle of Corrective and Preventive Actions (CAPA), including root cause analysis, implementation of corrective actions, effectiveness checks, and documentation.
- Collaborate with cross-functional teams to ensure long-term compliance and quality improvements.
- Lead and coordinate equipment, process, and software validation activities.
- Ensure proper planning, protocol development, execution, deviation handling,
and reporting are in compliance with regulatory requirements and internal procedures.
- Oversee creation, revision, approval, and archiving of controlled documents including SOPs, work instructions, forms, and quality records.
- Ensure alignment with document control policies and support training on new or revised procedures.
- Support the implementation and monitoring of QMS elements (ISO 13485).
- Lead quality initiatives and gap assessments, and drive continuous improvement through internal audits, KPI monitoring, and quality review meetings.
Qualifications
- Bachelor's degree in Biomedical Engineering, Biotechnology, or a related field in life sciences or engineering
- Minimum of 57 years experience in Quality Assurance within the medical device or pharmaceutical industry, including audit preparation, nonconformance handling, and quality system maintenance
Knowledge, Skills, and Abilities
- ISO 13485 Internal Auditor certification (preferred)
- RCC-MDR or equivalent regulatory training (preferred)
- English and Korean bilingual (preferred)
-- In-depth understanding of ISO 13485 and QMS requirements
- Experience with CAPA systems, validation protocols (IQ/OQ/PQ), and document control procedures
- Strong attention to detail
- Problem-solving mindset
- Effective communication and documentation skills
- Ability to work in cross-functional teams
...biotechnology company creating innovative assays for ultra-rare analytes in infectious disease and beyond. With expertise spanning virology, immunology, and genomics, our team develops, scales, and commercializes complex assay workflows to support our biopharma partners from basic...
...Description:The Department of Biology at the University of Iowa invites applications for a tenure-track assistant professor position in genetics, beginning in the academic year 2026. We invite applications from candidates addressing fundamental and open questions in genetics...
...socially conscious businesses. We believe in the power of a well-designed t-shirt to raise vital funds and increase awareness of... ...of our clientshere!Who Were SeekingWe are looking for a Graphic Designer with killer creative instincts. You will get to flex your...
...build and support custom websites for Catholic organizations nationwide!About the Role:- We're looking for an experienced WordPress Developer with full stack capabilities to join our in-person web team. You'll primarily build and support custom WordPress websites...
...BARTENDER Yountville, CA Be part of the beginning! Join the team of the newest restaurant in Yountville, Clementine! JOB SUMMARY: As a Bartender, youll be at the center of the actionwelcoming guests, crafting drinks, and creating a vibrant, inviting...