Design and QA Controller

Design and Quality Administration Controller

Role Specification

Role Purpose and Contribution to the company

Support and take responsibility for the administrative and RA/QA related tasks within the Product Development group.

The contribution to the organisation is a. creating improved efficiency by implementation and controlling of article and document management system, b. adherence to quality standards required by our Notify Body, and c. maintain the excellent supplier design transfer.

Key Result Areas (KRA's)

The management, realization and reporting of:-

*Supplier technical agreements
*Implementation and controlling of article and document management system
*Device Non Conformities (coordinating supplier requests and goods incoming inspection)
*Change order/Projects execution, release and distribution


As job descriptions cannot be exhaustive, the post holder may be required to undertake other duties that are broadly in line with the KRA's listed above.


Tasks
Specific;
Implementation and control of article and document management system - PD project leader for implementation and manager of the system once implemented.

General:
Supplier technical agreements; Management over Neoss 3-4 main supplier technical agreements.

Nonconformities - Device. Coordinate deviations requests from suppliers or complaint investigates related to suppliers

Article and Document control;
- Release articles and documents, file originals, update registers, storage of document

Label specifications;
-Create and update label specifications

Tasks Related to Change order processing
Prepare Change proposals:
- identify doc/drw/spec included in change through document management system

Execute changes:
- update doc (supplier agreements)
- Initiate and collect drw/spec changes/picture creation
- Initiate and collect cost info from suppliers
- Initiate webb updates, product updates, software updates

Sign off changes:
- collect and distribute change doc pack
- coordinate signing

Release and communicate changes:
- Distribute change with relevant material to involved parties
- Store sign doc/drw/spec/printed material,
- Update doc reg.
- Supplier agreements - implement changes including direct signing

Key Interfaces and Reporting Relationships

The reporting lines for product development, quality and documentation are clear - Design and Quality Administration Controller to CTO who has the final responsibility.
The main internal contacts others than PD/Design are with Operations, QA/RA and Marketing/Sales. The main external contacts will be with supplier's key account managers and quality control staff. Travel will take place to the head office and main suppliers a few times a year.

Essential Skills, Experience and Qualifications for position

*Accurate
*Supplier relations (i.e. agreements, logistics, commercial)
*Quality Control (i.e. inspection control, non-conformity handling)
*Business system: 5 years extensive experience with article structure and document management and handling
*Driven and Self propelling
*English
*Social
*Analytical

Desirable Skills and Experience for position
*Computer literate, experience in Excel, Word and FileMaker.
*Experience from the dental implant field