Senior Quality System Engineer // Johnson & Johnson in Le Locle

veröffentlicht
Kontakt
Andrea Oliveira, Randstad Inhouse Services Johnson&Johnson Neuchâtel Campus
Jobtyp
Temporär
jetzt bewerben

job details

veröffentlicht
Ort
Le Locle, Neuenburg
Sektor
Life Sciences
Jobtyp
Temporär
Referenznummer
133056-8255
Kontakt
Andrea Oliveira, Randstad Inhouse Services Johnson&Johnson Neuchâtel Campus
Telefon
032 934 90 38

Stellenbeschreibung

Caring for the world … one person at a time inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that is anchored in the internationally applicable Credo. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. We have more than 260 operating companies in more than 60 countries employing approximately 134,000 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.

Main Responsibilities

  • QSMR meeting facilitator: ensure logistic of meeting, collect the datas and information, ensure analyze of datas and compliance with QSMR procedures and assist the management representative during the meeting by creating the meeting minutes.
  • Ensures quality systems are effectively deployed.
  • Leads and participates in quality system improvement initiatives.
  • Determines root causes of quality issues and develops corrective action and recommendations.
  • Reviews process change recommendations, as appropriate.
  • Establishes, maintains and implements communications to increase awareness and promote improvement of quality issues across the business.
  • Assists with external audits, generating reports with corrective action plans and ensuring implementation of corrective actions in a timely fashion
  • Ensures consistent and correct execution of Quality System ? Regulatory procedures at the site to maintain the quality and compliance of the processes and the records of regulatory documentation provision. This includes:
    • Collaborate with affiliates and support US RA departments to make sure that the requested documents are complete, accurate and provided in a timely manner
    • Coordinate regulatory shipping restrictions process and quality restrictions
    • Review related procedures
    • Manage certificates, Declarations of Conformity, external standards
  • Establish and follow the purchase orders in the system ARIBAEnsure external and internal audits preparation (logistic, organization of FR and BR, material order…)
  • Own CAPA process as backup including CRB (CAPA Review Board)
  • CAPA facilitator as backup and EtQ administrator
  • Document control activities as backup

Qualifikation

Who we are looking for

  • A minimum of a Bachelors Degree is required, preferable in Engineering, a Life Science or a related technical discipline. Masters degree is preferred.
  • 3+ years of professional work experience within a quality assurance or compliance audit environment is required
  • Experience working in a GMP manufacturing environment is preferred
  • Strong communication, organizational and interpersonal skills
  • Strong statistical and analytical problem solving skills
  • Ability to collaborate with all levels of management across multiple sites and functions
  • Very good level of business French and English
  • Knowledge of Microsoft Office tools

This role based in Le Locle (NE), Switzerland will initially be limited to approx. 9 months. If you are interested in working for a global leading health care company in a challenging role, then send us your application in English or French today. Or give us a call if you have any questions!