Senior Design Quality Engineer

Senior Design Quality Engineer

To provide QA technical and compliance expertise as part of teams tasked with establishing customer needs, developing new products and/or modifying existing designs. Assure compliance to applicable regulations and lead quality activities such as risk assessments, device testing, audits, procedure development, documentation review and changes to controlled documents. Provides design control, risk management and compliance support for product design and manufacturing, corrective and preventive actions, product/process improvements and complaint investigations.

Duties & Responsibilities

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate, procedures and guidelines, this position:

·       Responsible for ensuring Design control and Risk Management activities, wherever they are performed comply with the requirements of the Design Control and Risk Management processes.

·       Provide Quality support/guidance to R&D projects leads/team members.

·       Provide direction and support to Design Assurance engineers and Quality Engineers.

·       Co-ordinate the Design Assurance Engineer resources to support business objectives.

·       Resolve project issues by working with team members, suppliers, and others as appropriate.

·       Apply thorough, systematic problem-solving methodologies in identifying, prioritising, communicating, and resolving quality issues.

·       Manage and maintain the records related to design control projects.

·       Contribute and participate in design review meetings.

·       Provide input into the generation of risk management file documents; Risk Management Plan, dFMECA, pFMECA and associated reports.

·       Provide input into development of protocols / reports supporting the Design control process.

·       Provide input and review to protocols and reports for sterilization, biocompatibility and packaging validations.

·       Co-ordination of timely review and approval of all details in R&D batch sterilization records as meeting the requirements of the cycle validated and appropriate for the product.

·       Co-ordination of timely review and approval of production records and sterilization records of product manufactured during the design control process to facilitate timely approval of Design protocols and reports.

·       Support bench test activity as required.

·       Support the translation of the design requirements into manufacturing requirements.

·       Ongoing monitoring of data from Quality Management systems and provision of immediate feedback to quality management on deviations or issues of concern.

·       Administration and management of the systems for CAPA, non-conformances and for supplier corrective actions.

·       Leads and/or facilitates compliance and improvement activities associated with the Neuravi quality system (e.g. CAPA).

·       Preparation of data as applicable for use in management review.

·       Act as an audit escort and/ or support coordination of backroom activity during inspections as required.

·       Support internal/Supplier audits as scheduled.

·       Support regulatory activities as requested by management.

·       Compile and conduct Quality System training for employees as directed,

·       Represent the company professionally and positively externally to agencies, vendors and regulators.

·       Responsible for communicating business related issues or opportunities to next management level

·       Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

·       Performs other duties assigned as needed

Experience & Education

·       Minimum education of degree in a technical field is preferred.

·       Minimum 5 years’ experience in the medical device industry and/or IVD/pharmaceutical, with at least three years in a position with direct responsibility for QMS processes/sub-processes.

·       Demonstrated knowledge of the application of the principles, concepts and practices of design control, sterilization and Quality Assurance processes.

·       Experience in preparation, participation and response to external agency inspections e.g. FDA and Notified Body Inspections

Required Knowledge/Certifications

·       Thorough knowledge of Design Control requirements and processes.

·       Working knowledge of 21 CFR 820, ISO13485 with familiarity of other foreign medical device quality system requirements.

·       Ability to handle multiple projects simultaneously and to discern major quality issues.

·       Ability to work well under deadlines and pressure.

·       Ability to work on own initiative and as a team player.

·       Ablility to build good, strong and positive working relationships with cross functional teams internationally.

·       Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience.