Quality Systems Engineer

Phillips-Medisize A/S

Østjylland (Aarhus)

Position Overview:
Phillips-Medisize, LLC is seeking a Quality Systems Engineer to serve as global resource and subject matter expert to manage Divisional Quality Management System, European QMS and regulatory requirements for cGMP, ISO13485.

Essential Functions:

  • Work closely with global sites to implement the Quality Management System standardization and integrate with the ERP system implementation and maintenance.
  • Develop meaningful metrics to gain understanding of current state of QMS and manage the monthly KPI review process
  • Participates in audits and regulatory inspections
  • Provide GMP guidance to facility personnel
  • Support product compliance by working with the Quality organization.
  • Evaluate processes for updating techniques, quality and overall efficiency to improve operations
  • Instill a mindset that will proactively cause those involved in the business to put all GMP regulations at the forefront of their day-to-day activities
  • Regularly research and evaluate regulatory trends to insure the compliant systems
  • Provide periodic status updates and reports
  • Reviews regulatory, program and customer requirements ensuring early quality involvement in program development
  • Travel to PMC facilities as required to support business needs

Required Qualifications:

  • BS plus a minimum of four years of related experience within a regulated environment, or equivalent industry experience
  • Knowledge of GMPs Regulations (13485, 820, 210/211, EU)
  • Internal Auditor (external lead training preferred)
  • Strong communication, teamwork, and organizational skills
  • Ability to manage small projects/programs with limited assistance from others
  • Knowledge of FDA Quality System Requirements, ISO 13485, ISO 9001, ISO 14971 and other medical device regulations, both domestic and international.
  • Must interact with all levels of managements, co-workers, and regulators
  • Leadership skills including ability to lead, mentor, and maintain confidentiality
  • Strong written, verbal and interpersonal communication skills

With your application, you agree that your information will be recorded in our files (up to 6 months after finalizing the position) and if necessary, forwarded to affiliated companies.

We are an equal opportunity employer.

The Company – in short
Phillips-Medisize, LLC, a Molex company, is a leading global outsource provider of design and manufacturing services to the drug delivery, consumable diagnostics, medical device and specialty commercial markets.

Read more about Phillips-Medisize A/S at www.phillipsmedisize.com or follow us at LinkedIn.

To apply for this job please visit sjobs.brassring.com.

Login for at se hele opslaget

Dette jobopslag er kun tilgængeligt for vores brugere. Log ind eller opret en profil - det er gratis og tager kun to minutter.

Log ind med sociale medier

Log ind med din karriereprofil


Glemt kode Ny bruger

Ansøgningsfrist: snarest muligt
Angiv venligst i din ansøgning, at du har set opslaget i Akademikernes Jobbank

Østjylland (Aarhus)
Maskin & Design
Produktion, Logistik & Transport
Teknik & Teknologi
Data & analyse
IT - Software
Ledelse & Planlægning

Medicom Innovation Partner A/S - hurtigt overblik

Gimsinglundvej 20
7600 Struer
Logo: Medicom Innovation Partner A/S
Efterspørgsel efter nye talenter

Hvilke jobtyper og arbejdsområder udbyder vi normalt og hvor mange nye talenter søger vi efter?


Få mere info omkring vores virksomhed på vores egne websider:


Medicom Innovation Partner A/S i Google

Er der andre informationer om os, som du burde vide? Se, hvad en Google-søgning siger.