Derived from job-description analysis by Serendipath's career intelligence engine.
Original posting from Rangam via LinkedIn
Quality Senior Engineer I
Duties
- Review, remediate, and migrate legacy CAPA records into EtQ to ensure completeness, accuracy, and compliance with global procedures.
- Manage assigned CAPAs through initiation, investigation support, action tracking, effectiveness verification, and closure.
- Perform gap assessments of CAPA records and support correction of documentation deficiencies to meet regulatory and internal quality system requirements.
- Partner cross-functionally with Quality, Regulatory, Operations, and Engineering to support CAPA execution and remediation activities.
- Support compliance to global CAPA procedures, including documentation standards, timeliness expectations, and record retention requirements.
- Assist with training and user guidance related to CAPA procedures and EtQ processes.
Skills
- Working knowledge of CAPA processes, root cause analysis, and quality system requirements.
- Experience with electronic Quality Management Systems (EtQ preferred).
- Knowledge of applicable regulations and standards, including 21 CFR Part 820, ISO 13485, and risk-based quality principles.
- Strong technical writing and documentation review skills.
- Strong organizational skills with high attention to detail and ability to manage multiple priorities.
- Analytical/problem-solving skills with ability to identify gaps and drive resolution.
- Ability to work cross-functionally and communicate effectively across levels of the organization.
- Proficiency with Microsoft Office (Excel, Word, PowerPoint) and document control systems.
- Medical device or other regulated industry experience preferred.
Education
- B.S. in engineering or an alternative Bachelor’s degree program
- 3-5 years of experience required in a Quality Engineering role, preferably supporting CAPA processes
- Knowledge of FDA QSR (21 CFR 820), ISO 13485, and ISO 14971 preferred.
- Knowledge of design controls, risk management, FMEA, CAPA, root cause investigation and statistical analysis.
- Certified Quality Engineer (CQE) and Medical device, particularly Orthopedic industry, experience preferred
Career page link: https://talentarbor.com/job/details/138226/3/560/senior-quality-engineer-englewood-co-us
Source: Rangam careers (LinkedIn)