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
Do you love building immersive game experiences with cutting-edge tech? Join our Talent Community and stay on our radar for future Game Development opportunities with top-tier global clients. This is not an active opening. By applying, youll be considered when a suitable...
...excellent incentives, unlimited opportunities for growth, and ports of call that will leave you breathless.Key Responsibilities As a Tailor, you will play a crucial role in maintaining uniforms and linens, performing alterations and repairs, and supporting the smooth...
...and staff members at each of our communitieswork together to build a strong network of care and support, we rely on our dedicated volunteers to help maintain the positive and supportive atmosphere we have created. Additional Information Senior Lifestyle...
...Job Summary (Product Design Engineer - Configuration Engineer - Aerospace): - Serve as Product Design Engineer (Configuration Engineer) in the aerospace industry. - Location: Kalamazoo, MI (Onsite). - Full time or long-term contract position. - Must have...
...Main Responsibilities of a Cook: Preparing workstations, cooking ingredients, and kitchen equipment for cooking. Cooking and arranging food. Cook Job Description: We are looking for an experienced cook to fill a vacant spot in our kitchen staff and contribute...