Beschreibung
Projekt Nr.: A3940Funktion Qualitäts Manager (contract)
Branche Medizintechnikunternehmen
Pensum 100%
Arbeitsort Bern Ost
Antrittstermin 08.07.2013
Dauer 6 Monate mit Option
Anzahl Stellen 3
Stellenbeschreibung
https://www.ghrgroup.ch/projekt-details/orderNr/A3940.html
Für unseren Kunden suchen wir mehrere sehr erfahrenen Qualitäts Manager wie folgt:
Main Responsibilities:
With oversight from the Core Team Leads, determine and report on the state of compliance of the quality system versus regulatory standards (ISO, FDA, etc.).
Audit sites’ inspection Plan to the standards and report out on findings (both current state and retrospectively).
Make recommendations to achieve compliance where shortfalls are found.
Provide Audit reports as directed.
Perform analyze and define Inspection Plan as necessary.
Generate Inspection Plan as necessary.
Background on statistics.
Background on validation.
Be willing and able to travel domestically to other Legacy Synthes EU sites as required.
Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines.
Generate DCRs / DCOs that these achieve the regulatory and the business requests. (will be trained on the Synthes System).
Be able to work with various databases to extract and report out required information (Excel, Access, Q-DAS SAP etc.)
Good communication skill.
Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations at all times.
Excellent organizational skills, readiness to take on responsibility, reliable, proactive & self-driven, very good communicational skills, customer oriented.
Team player.
Travel required form site to site.
Be able to manage effectively multiple priorities and tasks.
Must-Skills:
Minimum of 4 years quality planning
Compliance experience in the medical device.
Documented training in FDA QSR, ISO required.
Proficient in the use of spreadsheet software (Access / Excel etc.)
Engineering, Manufacturing Degree BSc
Nice to have:
Prior experience in medical device / pharmaceutical remediation preferred.
Familiarity and interaction experience with regulatory auditing bodies preferred.
Diverse Tätigkeiten gemäss Projektleiter
Sprachen
Sprache mündlich schriftlich Priorität
Englisch gut gut ein Muss
Deutsch sehr gut sehr gut ein Muss
Wir freuen uns auf Ihre Bewerbung
André van Sprundel
CEO
GHR Global Human Resources AG
Blegistrasse 13
CH-6340 Baar / ZG
Tel:
Direktnr:
Fax:
E-Mail:
Web: www.ghrgroup.ch
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