Capa Specialist Dvůr Králové nad Labem

Capa Specialist

Operating Company: Spark
Location: Dvur Kralove nad Labem,,Czechia
Date Posted: October 2, 2024
Req Number: R5021175
- Provides direct support to the QMS Manager to ensure the implementation and effectiveness of the CAPA program in the organization.
- Supports the QMS Manager with the collection and analysis of data and Internal and External Quality Key Indicators (Customer Complaints, Internal Rejections, Internal Audits, Training, etc.) to determine the need to create new Corrective and/or Preventive Actions.
- Coordinates the research and elaboration of action plans for CAs and / or PAs that result from the different sources of internal and / or external quality information.
- Prepare and administer CAPA files in accordance with established procedures.
- Coordinates the timely closure of all CAPA implementation plans through the Daily Management process and monthly CAPA Review Board (CRB) meetings.
- Prepares monthly KPI reports and distributes them both internally and externally as needed.
- Provides support to the QMS Manager during the communication and follow-up process directly with their corporate (Envista) counterparts.
- Coordinates and monitors QMS training program.
- Communicates significant issues or developments identified during CRB meetings and provides recommended process improvements to management.
- Works effectively within a cross functional team.
- Previous experience working in an FDA regulated environment is desirable.
**Job Requirements**:
- Effective interpersonal communication skills and able to interface with cross functional teams.
- Strong technical writing skills; able to explain technical terminology in layman’s terms to product development groups, peers and senior management.
- Possess critical thinking skills and able to be assertive & challenge the process in a diplomatic manner.
- Adaptable to work with software-based development and automated processes.
- Possess critical thinking skills and able to be assertive & challenge the process in a diplomatic manner.
- Possess 2-4 years of related experience in quality assurance preferably within the medical device industry
**Operating Company**:
Spark
The Spark Clear Aligner System is manufactured by Ormco, a global leader in innovative orthodontics products. Spark aligners are made with TruGEN, the latest innovation in clear aligner material. In the same way that Spark is designed to give orthodontists more control and flexibility, our careers are designed to give you more control and flexibility. Working at the intersection of technology and patient needs, you’ll be positioned to drive disruptive thinking and spark your career.

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