1+ months

Quality Engineer Compliance

Cambridge, MA 02139
**Job Purpose:**

To provide design control and risk management support to combination product/medical device development programmes. This will chiefly involve generation and review of documentation required for design history files. Other responsibilities will include facilitation and documentation of risk management activities associated with combination products/medical devices. The role is based in Cambridge; however, project teams are global in nature.

**Position Responsibilities:**

+ Generation, approval and retention of Pfizer device design control and risk management documentation ensuring that quality and regulatory requirements are satisfied.

+ Support and facilitation of effective risk management activities at external design companies and manufacturing facilities related to assigned projects.

+ Provide input and support to human factors engineering documentation.

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

+ Support device design and manufacturing investigations from 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.


+ Working in accordance with relevant standards and regulations, specifically ISO 13485, ISO 14971, 21 CFR 820, EN 60601, EN 62304, EU Medical Devices Directive and EU Medical Devices Regulation.

+ Developing drug delivery devices as a team member or significant contributor.

+ Developing documentation used as components of Design History Files, Risk Management Files and appropriate regulatory submissions.

+ Working to schedule targets.

+ Collaborative team working both internally and externally with multi-national and multi-disciplinary teams

+ Proven problem solving capability


Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Research and Development


Posted: 2020-05-05 Expires: 2020-07-05

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Quality Engineer Compliance

Cambridge, MA 02139

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