Job Title: Quality Engineer II, CAPA
 

The Quality Engineer II, CAPA will report to the CAPA Manager and will be responsible for leading CAPA activities from initiation to closure.

The Quality Engineer II, CAPA, will report to the CAPA Manager and will be responsible for facilitating the CAPA program to solve complex business problems affecting Omnicell’s customers. 

 

Responsibilities:

Facilitate timely and effective completion of activities throughout the CAPA lifecycle including, but not limited to:

Collaborate with issue identifiers to clarify information associated with newly opened Corrective Action Requests (evaluate issue descriptions for objectivity, risk, appropriate data and records, etc.) Organize and lead Corrective Action Board (CAB) meetings, prepare accurate meeting records Work with CAPA Owners and Subject Matter Experts to elicit information and investigate issues, lead application of problem-solving tools Conduct training on CAPA and Root Cause Analysis  Guide development of targeted action plans and effectiveness checks Ensure appropriate objective evidence is included in CAPA records Screen results of completed activities prior to CAB meetings Analyze quality data and apply statistical techniques to identify existing and potential causes of non-conformances Perform periodic trend analysis and corrective action effectiveness measures of all quality system events and identify opportunities for improvement Ensure CAPA documents/records are compliant with applicable regulations and standards Assist with educating employees on the CAPA process Support Global Quality assurance activities related to Internal Audit, QMS training, or document control  Conduct internal audits as needed 

 

Required Knowledge and Skills:

Ability to work collaboratively with peers and team members; and to effectively interact with and influence employees on all levels Strong Project Management skills, including ability to project manage all CAPA activities Knowledge of tools and techniques required to perform thorough root cause analysis investigations Able to understand and analyze complex problems, including software and hardware design issue. Ability to analyze data and apply statistical techniques Proficiency with common MS office programs (Word, Excel, PowerPoint, Project) Strong understanding of applicable regulations and standards such as 21 CFR Part 820, ISO 13485, and ISO 9001

 

Basic Qualifications:

Bachelor’s degree 3 years of Quality Management Systems experience

 

Preferred Qualifications:

ISO 9001, ISO13485 or FDA regulated medical device experience Bachelor’s degree in a STEM field 3 years of direct CAPA and/or Quality Assurance experience Lean six sigma certification  Audit certification

 

Work Conditions

Hybrid WFH/Office Environment  Potential Occasional Travel