Senior Quality Engineer

This Senior Quality Engineer is responsible for supporting and implementing improvement activities and projects. Provides QA support to stakeholders across a range of Quality processes. Responsibilities include Risk Management, Audit management and continuous improvement.

Responsibilities:

• Assignments may include areas such as Risk Management, Audit management, non conformances, deviations, material control, product release, CAPA/complaint handling, investigations, and EQA.
• Actively participate on Quality teams and cross-functional project teams as needed
• Identifies product and process improvements to reduce complaints and cost of poor quality
• Provides recommendations for improvements as they are identified during the analysis, tracking, and trending of quality review inputs
• Facilitate the evaluation of complaints, including assessment, investigation, containment, review, approval and determination of on-going needs
• Monitor and interpret new and existing standards and regulations and implement solutions to maintain compliance.
• Participate as the subject matter expert during audits and/or inspections as needed
• Promotes global awareness and provides training to policy and procedures
• May be responsible for maintenance of local work instructions, SOPs and training of Quality Engineers and Associates.
• Provides management with status updates on assigned responsibilities and goals and escalates issues in a timely fashion
• Trend, analyse, and report on quality data to improve products and processes.
• Other such duties that may be determined by Management.

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Preferred Requirements:

• Experience in a regulated environment, ideally medical laboratory testing, medical device development or other regulated industry.
• Strong knowledge of ISO standards such as ISO 15189, ISO 17025, ISO 13485
• Excellent attention to detail, well organized, able to work independently and with a team and provide SME leadership.
• Interpersonal, verbal and written communication skills and ability to establish relationships across functions and different levels.

Experience/Education:

• Typically requires a university degree and a several years of related experience