
Senior Quality Engineer
- Cambridge
- Permanent
- Full-time
- 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.
- 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.
- Typically requires a university degree and a several years of related experience