Senior Design Assurance Engineer

 

Description:

DUTIES & RESPONSIBILITIES

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations, 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 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 AND 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