The Quality Engineer is responsible for providing manufacturing and/or engineering process
support in accordance with documented procedures and practices. The Quality Assurance
Engineer is a key technical role responsible for the development, implementation,
improvement and continuous reinforcement of established total quality fundamental
practices that are utilized in the local business. The role involves hands-on work in QMS areas
such as CAPA, training and design controls.
Key responsibilities/essential functions include:
Support the Quality Management System (QMS) in compliance with applicableregulations and standards (e.g., FDA 21 CFR Part 820, ISO 13485)
Assist in the creation, review, and maintenance of quality documentation, including procedures, work instructions, and records
Support design control activities, including document reviews, traceability, and verification/validation (V&V) documentation
Assist with nonconformance investigations, root cause analysis, and corrective and preventive actions (CAPA) under guidance from senior QA staff
Support internal audits and regulatory inspections by preparing documentation and responding to requests
Review and process quality records such as change requests, deviations, and complaint documentation as applicable
Collaborate cross-functionally with engineering, manufacturing, and regulatory teams to support product quality and compliance
What do we think you need?
Required Qualifications:
Bachelor's Degree.
1-3 years of experience in manufacturing, engineering, quality assurance experience
Preferred Qualifications:
Knowledge of Six-sigma tools/ problem solving / statistical techniques
Minimum 2 years Quality Assurance/Quality Engineering experience in the medical device or pharmaceutical industry
Experience with Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR and ISO 13485
Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes
Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing in a medical device environment.
Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production & process controls; Corrective & Preventive Action (CAPA), complaints & risk management & product quality improvement using tools such as six sigma, DFR, etc.
Demonstrated collaboration, negotiation & conflict resolution skills
Excellent oral communication & report, business correspondence & procedure-writing skills
Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance
Change agent with energy, passion & enthusiasm to drive change
Exceptional analytical, problem solving & root-cause analysis skills
Ability to multi-task & handle tasks with competing priorities effectively