Beschreibung
Projekt Nr.: A3942Funktion Qualitäts Manager (contract)
Branche Medizintechnikunternehmen
Pensum 100%
Arbeitsort Bern Ost
Antrittstermin 08.07.2013
Dauer 6 Monate mit Option
Anzahl Stellen 2
Stellenbeschreibung
https://www.ghrgroup.ch/projekt-details/orderNr/A3941.html
Für unseren Kunden suchen wir mehrere sehr erfahrenen Qualitäts Manager wie folgt:
Main Responsibilities:
Quality Department
Size of the team (how many people, orgs charts) 1 to 3 members
With oversight from the Core Tam Leads, determine and report on the state of compliance of the quality system versus regulatory standards (ISO, FDA, etc.).
Audit sites’ Calibration, MSA, Gage R&R.
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.
Consultancy and guidance of all employees and manager regarding calibration and measurement equipments and operational practices.
Training of all involved employees along the Calibration, MSA, Gage R&R process.
Bringing in of improvement proposals, which increase the productivity quality of measurement equipments and operational practices.
Excellent organizational skills, readiness to take on responsibility, reliable, proactive & self-driven, very good communicational skills, customer oriented.
Be able to manage effectively multiple priorities and tasks.
Be willing and able to travel domestically to other Legacy EU sites as required.
Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines.
Be able to work with various databases to extract and report out required information (Excel, Access, Q-DAS SAP etc.).
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.
Desired competencies:
Minimum of 10 years experience as Calibration engineer in medical device metal industry.
Compliance experience in the medical device.
Familiarity and interaction experience with regulatory auditing bodies preferred.
Documented training in FDA QSR, ISO required.
Proficient in the use of spreadsheet software (Access / Excel etc.)
Versed in the calibration, MSA and Gage R&R methodology, as defined by GAMP, AAMI, ASQ, DePuy or Legacy
Analytical, thorough, accurate and proficient in the use of computers. Manufacturing processing background is required, as the special processes are generally not verifiable; thus, the validation requirement.
Proficient in the related ISO 13485 standards sections and related 21 CFR 820 regulatory subchapters
Ability to travel, to perform internal audits and be able to work independently – with minimal supervision
Degreed Engineer (Mechanical) Measurement Equipment Specialist
Be able to work with various databases to extract and report out required information (Excel, Access, Q-DAS, SAP etc.).
Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines.
Excellent organizational skills, readiness to take on responsibility, reliable, proactive & self-driven, very good communicational skills, customer oriented
Be able to manage effectively multiple priorities and tasks.
Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations at all times.
Minimum of 10 years quality / compliance experience in the medical device or pharmaceutical industries.
Proficient in the use of spreadsheet software (Excel, Access, Q-DAS, SAP etc.
FDA QSR, ISO 13485
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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