QA Specialist

**Descripción y detalle de las actividades**
- Reviews all product complaints entered into the complaint handling data base by Customer Service/Sales, to ensure accuracy of the data entered to include but not limited to the product indicated aligns with the complaint statement made by the customer. Evaluates, assigns investigation(s), and tracks timely completion and closure of complaints. Ensures the integrity and completeness of Complaint Files prior to closure. Responsible for reviewing all product complaints to differentiate between serious and non-serious complaints and determine reportability to worldwide regulatory agencies within the required timeframes. Reviews and approves complaints and complaint closure information for completeness using Good Documentation Practices while interpreting and analyzing statistical data to identify trends. Oversees product complaint investigations to resolution while ensuring documentation of clear, complete and timely investigations that are supported by data in accordance with company procedures and regulatory compliance. Responsible for assuring timely review and closure of complaints while maintaining efficient workflow, work assignments and throughput. Ensures accurate documentation of evaluation and investigation results with the assigned complaint records. Has primary responsibility in overseeing the complaint handling data base in accordance with documented procedures to ensure data integrity, regulatory compliance, and customer satisfaction. Reviews global medical device complaints for the identification of reportable events in the local countries and for any reciprocal reporting requirements within the required timeframes including but not limited to Medical Device Reports (MDR) and Medical Device Incident Reports (MDIR). Responsible for the submission of US MedWatch reports and ensuring US reportable events are reviewed prior to submission and submitted within the required timeframes. Prepares formal reports for adverse event complaint responses to regulatory authorities.

**Experiência y requisitos**
- HS Graduate and some college prefered (not essential) - 3-5+ years of manufacturing, quality assurance, and/or engineering experience preferred;
- Fluent English speaking and writing skills
- Excellent communication and influence skills with the ability to work interactively with off-site resources;
- Working knowledge of US medical device regulations (21 CFR Parts 820, 803, and 806) required;
- Working knowledge of standard quality system requirements (ISO 13485, Medical Device Directive, Canadian Medical Device Regulation, MDSAP) preferred;
- Prior experience as an internal auditor preferred;
- Ability to assess risks, and where appropriate, recommend contingency plans and strategies to mitigate risks;
- Strong problem-solving skills and ability to make firm decisions;
- Highly motivated self-starter with the ability to function in a fast paced team oriented environment with mínimal supervision;
- Must have excellent problem solving, time management, organizational, and interpersonal skills, with the ability to work independently;
- Ability to deal with a variety of variables in situations where limited information exists;
- Ability to manage conflict;
- Ability to articulate thoughts and ideas effectively through both written and oral communication;
- Proficient in Microsoft Office software, including Outlook, Word, Excel, and PowerPoint, as applicable;
- Microsoft Dynamics AX knowledge preferred;
- Ability to perform effective investigational and root cause activities;
- Ability to multitask and prioritize work to meet defined timeliness requirements;
- Must be detailed oriented and well organized;

**Organización**
- Ds Orthodental**Giro**
- Medicina**Actividad principal**
- Fabricación de productos para ortodoncia**Número de empleados**
- 150**Número de vacantes** 1**Área** Calidad**Contrato** Permanente**Turno** Diurno**Jornada** Tiempo Completo**Estudios** Carrera Trunca**Sexo** Indistinto