
Senior Quality Systems Engineer
- Arden Hills, MN
- $82,600 per year
- Permanent
- Full-time
- Support site CAPA and NCEP activities as a SME, project manager and/or trainer
- Track and trend CAPA and NCEP related information and report at various review boards to a broad audience
- Champion quality and compliance to quality requirements throughout the NCEP and CAPA process
- Responsible for ensuring timely implementation of projects within the Arden Hills Quality Operations organization, including continuous improvement projects
- Responsibility to identify and escalate NCEP/CAPA areas in need of improvement, identify improvements, and track progress through metrics
- Apply sound, systematic problem-solving methodologies to ensure robust solutions that resolve quality issues
- Contribute actively to internal BSC global Communities of Practice
- Bachelor's degree
- Minimum of 5 years of related work experience, preferably in the medical device industry, or an equivalent combination of education and work experience
- Technical aptitude and demonstrated problem solving skills in the CAPA process
- Previous CAPA ownership
- Can use, teach and improve standardized tools
- Ability to influence the effectiveness of each phase of the CAPA project indirectly lead, including in challenging situations
- Strong verbal and written communication, and organizational skills
- Strong networking skills to foster collaborative relationships
- Ability to communicate effectively with all levels of the organization
- Must be proactive and able to work independently with minimal supervision; strong collaboration skills are essential
- Ability to understand procedural documents and evaluate documents to ensure compliance to all applicable regulations and requirements