What are the responsibilities and job description for the QA Compliance Associate position at KYYBA?
Position Summary
Responsible for ensuring compliance with all applicable Corporate and Divisional procedures, Quality System requirements, and regulatory expectations.
This role performs detailed quality assurance reviews and provides line support for Relabeling, Addendum, and related production documentation. The position ensures complete and accurate review of LHR/eLHR, SAP transactions, and controlled documents while supporting Engineering, maintaining audit readiness, and driving continuous improvement initiatives.
Key ResponsibilitiesQuality Assurance & Documentation Review
- Perform comprehensive QA reviews of LHR/eLHR, SAP transactions, and related documentation.
- Verify accuracy, completeness, correct document revision usage, and adherence to procedures.
- Ensure compliance with all quality system and regulatory requirements.
Audit & Inspection Activities
- Conduct audits of materials, components, documentation, and production line activities.
- Perform visual inspections, sampling, and system verification against specifications.
- Support reduction of documentation and process errors through detailed review and timely escalation.
Production Line Support
- Provide daily QA support to Relabeling and Addendum operations.
- Ensure correct labeling, traceability, and documentation practices.
- Support approval and verification of training holds.
Engineering & Technical Support
- Assist Engineering with subtasks such as:
- Demonstrations
- Scrapping activities
- AQL sampling
- Testing of SAP/LHRBM or document changes
- Support additional technical evaluations as needed.
Continuous Improvement & Documentation
- Identify opportunities for process and documentation improvements.
- Support Change Orders and controlled document updates.
- Collaborate with cross-functional teams to enhance documentation accuracy.
SAP & Inventory Management
- Execute SAP transactions and inventory movements accurately.
- Handle discrepant materials in accordance with approved procedures.
- Ensure proper documentation and traceability.
Audit Readiness & Compliance
- Support internal and external audits.
- Ensure all documentation is complete, accurate, and readily accessible.
- Maintain ongoing audit readiness through strict procedural adherence.
Cross-Functional Support
- Support Quality, Operations, and Engineering with:
- COA requests
- ICS signature requests
- Retains management
Safety & Accountability
- Maintain schedule adherence and accurate time reporting.
- Complete required training and certifications.
- Follow safe work practices and participate in safety initiatives.
- Submit safety recommendations and near-miss reports.
Certifications & Additional Duties
- Achieve and maintain required certifications (QCRI, Relabeling, Addendum, QA Review).
- Support JI Assessor duties and other assigned quality functions.
- Perform additional duties aligned with Quality Management System and Environmental Management System objectives.
Required Skills & Competencies
- Strong attention to detail with high accuracy in documentation review.
- Working knowledge of:
- SAP
- LHR/eLHR systems
- AQL sampling methods
- Document control practices
- Ability to interpret:
- Procedures
- Material specifications
- Technical drawings
- Regulatory standards
- Strong communication and collaboration skills.
- Ability to work effectively in cross-functional environments.
Preferred Qualifications
- Familiarity with medical device regulations such as:
- ISO 13485
- 21 CFR Part 820
At Kyyba, the overall well-being of our employees and their families is important to us. We are proud of our work culture which embodies our core values; incorporating value, passion, excellence, empowerment, and happiness, creates a vibrant and productive atmosphere. We empower our employees with the resources, incentives, and flexibility that they need to support a healthy, balanced, and fulfilling career by providing many valuable benefits and a balanced compensation structure combined with career development.
Kyyba is an Equal Opportunity Employer.
Kyyba does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other b
Salary : $21 - $24