The Quality and Regulatory Affairs Manager 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 21 820 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