UDLØBET

Phillips-Medisize

Global Quality Account Manager - Medical Industry

Fuldtid

Permanent

Teknikerbyen 5, 2830 Virum, Danmark

SE PÅ KORT

ID: 2584025

Indrykket for 11 dage siden

Your Job

Phillips-Medisize is seeking a Quality Account Manager to be the key quality contact for strategic customers involving multiple Phillips-Medisize manufacturing locations and GID centers, mainly supporting our platform business from Design and Development through Commercialization.

What You Will Do

Design & Development Stage

Be the contact window to transfer quality documentation from GID centers to multiple Phillips-Medisize manufacturing locations, also be the quality leader to ensure all the quality deliverables from manufacturing locations could meet the requirements during Design & Development stages. Work directly with the Regulatory Affairs Team to ensure alignment and any gaps are addressed.

NPI & Mass Production Stages

Lead and coordinate the NPI AQP processes in terms of quality responsible areas by leveraging the quality resources from different quality organization in multiple Phillips-Medisize manufacturing facilities producing for the common strategic customers.

Drive the customer relationship management process between all Phillips-Medisize facilities and the strategic customer quality organizations, act as principal quality liaison between Phillips-Medisize facilities and the strategic customer, responding appropriately to internal and external customer needs.

Negotiate, review and approve the quality agreements and other quality requirements from strategic customers.

Participate in regular business reviews providing quality updates on the behalf of all Phillips-Medisize facilities producing for the strategic customers.

Track and report quality improvement initiatives and action items for the strategic customers.

Participate in post market changes, feedbacks and complaints, as well as the reporting to authorities by the assistance from the manufacturing locations and regional RA representatives.

Coordinate with internal RA (Regulatory Affairs) Teams or external RA consultants coordinating registration and post market regualtory activities are met for various global jurisdictions / markets.

Who You Are (Basic Qualifications)

Bachelor’s degree in engineering.

Several years of experience in Project/Quality engineering.

Be familiar with ISO13485, QSR 820, NMPA regulations etc.

What Will Put You Ahead

RA (Regulatory Affairs) background

Technical injection molding tooling, materials, manufacturing, quality, and product design skills.

Leadership skills including ability to maintain confidentiality and drive projects and new business processes, ie. project management.

Business insights and strategic thinking including ability to handle top pharma company expectations.

Strong stakeholder management skills

Embrace diversity (culture and personality).

Demonstrated superior communication, teamwork, and organizational skills.

Ability to develop and meet project/program schedules, along with contingency plans.

Ability to travel to Customers or Manufacturing Sites at least 10% of the time.

#LI-TN1

Husk at skrive i din ansøgning, at du så jobbet hos Ofir

Opret en jobagent

Tilføj denne søgning til din jobagent og få nye job direkte i indbakken

OPRET JOBAGENT

Bliv den første til at få besked når der kommer nye job

Du skal blot indtaste din e-mail her

Når du tilmelder dig, accepterer du samtidig vores privatlivspolitik. Du kan altid trække dit samtykke tilbage.

Andre brugere kiggede også på disse job:

Andre job der minder om dette

Verisure A/S

Kørende Salgskonsulent til salg af Tryghed – Sjælland

Fuldtid

Sjælland

Indrykket for 4 dage siden

Vi søger en erfaren og resultatorienteret Kørende Salgskonsulent til at gøre Danmark til et tryggere sted at bo ved at sikre endnu flere hjem og mindre virksomheder. Som Kørende Salgskonsulent vil du ... Læs mere

Royal Unibrew

Salgskonsulent - afløser Nordsjælland

Fuldtid

Nordsjælland

Indrykket for 10 dage siden

Salgskonsulenter – afløsere til Nordsjælland Royal Unibrew søger Salgskonsulenter - afløsere til at hjælpe os løbende fra midten af juni og henover sommerferien så har du lyst til at arbejde med nogle... Læs mere

Royal Unibrew

Salgskonsulent - afløser København

Fuldtid

København

Indrykket for 10 dage siden

Salgskonsulenter – afløsere til København Royal Unibrew søger Salgskonsulenter - afløsere til at hjælpe os løbende fra midten af juni og henover sommerferien så har du lyst til at arbejde med nogle af... Læs mere