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Job Details

Compliance Engineer

Company: Optimus Search Limited
Location: Stuttgart
Reference: BBBH7451
Closing Date: 18 Aug 17
Type: Permanent
Salary (£): 60,000 - 80,000
Benefits:

Job Summary:

Quality Engineer – permanentLocation: Stuttgart Salary: Up to €65,000 annuallyOverview:Reporting to: Director QA/RA GermanyKey ResponsibilitiesKey responsibilities will include (but are not limited to) the following: * Create validation plans/protocols for manufacturing processes in an GMP environment * Apply the GHTF validation guideline * Apply technical solutions to problem solving especially for medical devices containing an ancillary medicinal substance within GMP, EMEA and ICH-guidelin ...

Requirements:

Quality Engineer – permanent

Location: Stuttgart

Salary: Up to €65,000 annually

Overview:

Reporting to: Director QA/RA Germany

Key Responsibilities

Key responsibilities will include (but are not limited to) the following:

* Create validation plans/protocols for manufacturing processes in an GMP environment
* Apply the GHTF validation guideline
* Apply technical solutions to problem solving especially for medical devices containing an ancillary medicinal substance within GMP, EMEA and ICH-guidelines
* Apply technical solutions to quality improvement projects
* Use technical writing skills to clearly describe technical information
* Analyze customer complaints, identify trends and execute corrective actions
* Understand standards and their application to medical devices
* Planning, protocol generation, testing and report generation for medical devices
* Generation and maintenance of Technical Files for medical devices
* Review and update technical files in line with EU medical devices regulatory requirements
* Ensuring that records are filed in accordance with site procedures.
* Supporting R&D projects
*

Key Relationships / Interfaces

* Senior Engineering Manager
* Risk Manager, EMEA
* EMEA QA/RA
* EMEA Operations
* EMEA R&D
* EMEA HQ Support functions
* Global QA/RA

Essential Skills / Experience

* Engineering/Science qualification with about 5 years of work experience within R&D/QA/RA in a medical device or pharmaceutical environment.
* 2/3 years experience in R&D, QA/RA, Process Validations – essential
* 2/3 years experience in Risk, Clinical and Biocompatibility – an advantage
* Excellent technical writing experience within a medical device or pharmaceutical environment - essential
* Attention to detail and accuracy – essential
* Fluent German and English, both written and oral - essential
* Ability to work well under deadlines and pressure
* Problem solving skills for developing creative solutions and meeting objectives are required.
* Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook and Excel);
* Excellent analytical ability
* The ability to prioritize tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management.

Apply for this job: Compliance Engineer

Contact Information:

Address:  Head Office
171-177 Great Portland Street, London
W1W 5PG
England
Tel:  +44 (0) 20 3418 8033
Fax:  +44 (0) 20 7287 4908
Website:  Visit Our Web Site

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