Sign In
 [New User? Sign Up]
Mobile Version

Quality Engineer

Pfizer


Location:
Cambridge, MA
Date:
11/28/2017
2017-11-282017-12-29
Pfizer
Apply on the Company Site
  •  
  • Save Ad
  • Email Friend
  • Print
  • Research Salary

Job Details

**Job Purpose:**







+ To work with drug product teams and external design companies in developing device design control documentation.



+ To work with drug product teams and external design companies in developing device risk management and human factors engineering documentation.



+ To work with drug product teams and external design companies in developing design history files.



+ To assist in the generation of regulatory submission documentation for devices.







**Major Duties:**







+ Responsible for generation, approval and storage of all Pfizer device design control documentation for assigned device projects.



+ Responsible for generation, approval and storage of all Pfizer device risk management documentation for assigned device projects.



+ Ensure effective risk management activities at external design companies and all manufacturing facilities related to assigned projects.



+ Responsible for generation, approval and storage of all Pfizer device manufacturing control strategy documentation for assigned device projects.



+ Provide input and support to human factors human factors engineering documentation for assigned device projects.



+ Support the assessment of external design companies and suppliers for capability of quality systems, facilities and procedures to support device development and supply



+ Provide input to and support completion of external design companies/supplier device design and process risk assessments.



+ Provide input to purchase specifications for device assemblies and components.



+ Support the DCoE device design change control system ensuring that quality and regulatory requirements are satisfied.



+ Work as part of a multidisciplinary team to determine what performance factors of the drug delivery device are critical to the compliance of the finished product and their implications for assessments and investigations.



+ Assist in the application of design control as and when required to other device development projects.



+ Ensure effective device design change control, ensuring that quality and regulatory requirements are satisfied.



+ Provide support for generation and approval of DCoE equipment qualification documentation.



+ Support device design and manufacturing investigations from devices used in clinical trials and commercial manufacture.



+ Support the timely completion of complaints related to technical issues associated with devices used in clinical trials and commercial manufacture.



+ Support the generation of all regulatory submission data and content for assigned device projects.



+ Support internal and external audits of the DCoE Quality System.



+ Support the generation of DCoE Cambridge site quality metrics.



+ Support all DCoE Cambridge personnel in authorship, where appropriate, and ensuring compliance to Pfizer policies and procedures.







**Role Development:**







+ Develop technical expertise in device design control, risk management, human factors engineering, quality systems and in the regulatory requirements for devices.



+ Develop interfaces across Pfizer, developing common approaches to device quality across a range of devices.



+ Develop greater understanding of the role of DCoE and the Pharmaceutical Sciences organisation in the drug development process and its interfaces with other key lines e.g. Pharmaceutical Sciences Project Teams.



+ Develop technical expertise in specific area of involvement and become recognised as an increasingly competent technical contributor.







+ Expand and develop engineering and scientific skills.



+ Acquire understanding of specific drug delivery technologies for various dosage forms from in-vitro testing to clinical trials and commercialisation.



+ Generate opportunities to develop communication and negotiating skills to operate in a multidisciplinary environment, both internal and external to Pfier.



+ Develop team working skills and personal skills.







**Qualifications:**







**Essential** :







+ Degree, HND or equivalent in relevant subject.



+ History of working in accordance with the requirements of ISO 13485 and 21 CFR 820.



+ Thorough working knowledge of ISO 9001, ISO 13485,ISO 14971, 21 CFR 820 and the EU Medical Devices Directive.



+ Able to learn and apply established procedures in a reliable and consistent manner.



+ Able to anticipate what information is required by their colleagues and to disseminate it actively and efficiently.



+ Enjoys working within multidisciplinary teams in the development of leading edge designs and technologies.



+ Ability to plan, organise and prioritise own work with minimal supervision.



+ Capable consistently of accurately recording of all data, in compliance with SOPs.



+ Effective team worker.



+ Excellent attention to detail.



+ Willing to listen and take advice from others.



+ Shows initiative and has ability to think for self.



+ Comfortable working to agreed deadlines.



+ Takes pride in the quality of their work.







**Desireable:**







+ Evidence of sustained level of achievement.



+ Worked on the development and/or documentation of drug delivery devices or complex electro-mechanical products.



+ Working knowledge of EN 60601, EN 62304 and EN 62366.



+ Preliminary knowledge of the EU Medical Devices Regulation.



+ Able to prepare and present data to technical colleagues in a succinct and informative way.



+ Enjoys working within multidisciplinary teams in the development of leading edge designs and technologies.



+ Has a tenacious attitude towards solving and trouble-shooting technical problems.



+ Strives for quality and excellence in own work.



+ Ability to work/interact with a range of people.



+ Ability to adapt to change.



+ Flexible and resilient.



+ Excellent communication skills.







The closing deadline for applications is 11 December 2017



Day (standard) (United Kingdom)



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Apply on the Company Site
Powered ByLogo

Featured Jobs[ View All ]

Featured Employers [ View All ]