Senior Quality Engineer - Medical Device

Effectively utilize quality tools and processes such as product and process controls, risk analysis/management tools, validation, design verification, investigations, CAPA data, etc. to assure product quality

·Assures conformance with regulations of the FDA and other international regulatory agencies and may assisting in providing responses to the FDA and other regulatory agencies with respect to medical device compliance and validation questions.

·Work with product teams to understand product performance and improve quality systems capability

·Provides compliance guidance concerning development, application, and maintenance of quality standards as related to product development.

·Review and troubleshoot product and process specifications, policies and procedures; ensuring our ability to design and manufacture high quality product

·Effectively interact with cross-functional team members to bring new products to market with high quality, cost effective and timely results

·Ensure all Quality attributes for design changes and fixes are met. Work with cross-functional teams to coordinate product changes

·Provide corporate quality support, guidance and direction for all manufacturing facilities including on-market product issues to closure and escalating to senior management for support as necessary

·Ensure that potential product and process risks are evaluated, prioritized, and mitigated to continuously improve product quality

·Utilize a wide variety of data sources including product review, global complaints, manufacturing quality data, etc. Monitor product data to identify statistically significant trends and risks

Minimum of 5 - 10 years experience in quality, product design or product engineering in the medical device industry preferably with electro-mechanical/serialized devices

·Proficient using Microsoft Office (Excel, PowerPoint, and Word)

·Experience with risk management standards

·Demonstrated knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, CAPA, Complaints, Document Control, etc)

·Demonstrated experience with ISO, GxP, FDA or other key regulatory bodies

·Able to take a systems approach and to understand the interaction between components (i.e. hardware, software, consumables)

·Proven ability to work closely with engineering teams

·Certification and/or license in specific discipline is desired (e.g. CQE)

· Knowledge of engineering theoretical fundamentals and experimental techniques.

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