Key skills
SalesforceLeadershipCommunication
About this role
Role Overview
- Provide work leadership/mentorship to team members, including but not limited to, training support on processes and procedures
- Performs complex tasks to ensure compliance with quality standards
- Track daily team metrics to ensure performance targets are achieved
- Works with failure analysis engineers and other Post Market team members to ensure effective inspection, protocols, and procedures are implemented and maintained
- Assists in the development of protocols and standards to meet quality specifications and recommends procedural changes
- Perform product evaluation including root cause/troubleshooting and failure analysis
- Review applicable DHR’s, NCMR’s, CAPA’s, and deviations associated with individual complaints
- Summarize investigations with Root Cause Analysis and drive further action when appropriate
- Manages, facilitates, and participates in Continuous Improvement projects
- Approve / Sign-off work of failure analysis engineers and associates
- Gather, evaluate, and trend product reliability data
- Assist in cross-functional special projects
- Performs other duties as assigned
Requirements
- BS/BA degree in business, engineering, or scientific discipline
- 6 years of combined education and experience as a lead in engineering, technical or scientific discipline
- Preferred 2 years in a Quality related function working with QSR and/or ISO 13485
- General knowledge of performance metrics
- Electrical and mechanical background strongly preferred
- Effective verbal communication and excellent technical writing skills
- Proven experience to organize, prioritize and follow through on multiple tasks with minimal supervision
- Prior experience working in a regulated industry (medical device) and/or experience working in a bio-hazard/lab environment preferred
- Experience creating and analyzing charts and Pareto charts in MS Excel a plus
- Experience or certification in Lean Six Sigma, SPC, ASQ, and/or ISO process controls a plus
- Complaint management software skills a plus (i.e. Salesforce, Trackwise, PLM, etc.)
Benefits
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO)
- And additional employee wellness programs