Job Summary

　　Responsible for managing the continuous improvement of the CAPA system and administration to ensure policies, procedures, and system tools are updated to ensure consistency and compliance.

　　Responsible for assignment, timely execution, and effectiveness of CAPAs. This includes creating and issuing CAPAs, collaborating with functional teams and subject matter experts (SMEs) to ensure compliance and thorough determination of problem statements, risk assessment, scope, containment, root cause analysis, corrections, corrective and preventive action plans, and verification of activities.

　　Train and mentor CAPA owners in all required elements and best practices of CAPA, including well documented identification, containment, risk assessment, scoping, root cause analysis, correction, corrective and preventive actions with associated effectiveness checks. Ensure consistency in CAPA requirements and documentation practices across multiple departments, CAPA leads, SME contributors, and technical writers.

　　Regularly reports to site senior leadership on CAPA progress, effectiveness, and compliance and escalates attention when CAPAs may require additional resourcing or support.

　　Essential Job Duties and Responsibilities

　　Maintains and updates CAPA policies, procedures and tools and ensures training provides thorough instruction for consistency and compliance across many departments.

　　Provides continuous and rigorous assessment of site/s CAPA activities and documentation to ensure compliance with CAPA processes, FDA regulations, ISO 13485, ISO 9001, and medical device requirements through the review of CAPA records.

　　Provides guidance and mentors CAPA owners, CAPA leads and CAPA team members regarding the CAPA process, CAPA best practices,

　　Works cross-functionally with a sense of urgency to ensure timely, compliant, and effective CAPA records.

　　Supports internal and external audit activities and work to resolve audit nonconformities.

　　Support coordination of investigation, including investigation plans, and cross functional discussions, and root cause analysis.

　　Provides expertise in the application of quality tools including process mapping, problem solving, and root cause verification and the creation of system solutions for CAPA.

　　Assesses and identifies risk and evaluates deficiencies while partnering with system owners to develop remediation plans.

　　Work with SMEs for a thorough assessment of CAPA activities and documentation to ensure technical consistency and accuracy and compliance with medical device regulations, company standards and procedures. Collaborates with other site CAPA administrators to leverage shared opportunities for improvement and best practices.

　　Monitors and reports metrics for the CAPA system including on-time closures.

　　Escalates concerns to site senior leadership if CAPA progress indicates a need for additional resources or support. Help and support the implementation of Trackwise Digital CAPA tool.

　　Supplemental Data

　　This is mid-level position with room for growth and additional responsibility as skills are demonstrated.

　　Qualifications

　　Training and Education

　　ASQ Certified Quality Engineer required.

　　Bachelor’s degree in a related field preferred. ASQ Certification (CQE) or Six Sigma Black Belt may be considered in lieu of a degree., with a minimum ten years professional experience in a related field and demonstrated experience in CAPA investigations and technical writing.

　　Experience

　　Experience: Three of more years in an Engineering, Scientific or Investigative role is required

　　Experience with Quality Management Systems that are compliant to FDA 21 CFR 820, ISO 13485, ISO 9001, is required.

　　Application and use of Continuous Improvement and QA tools (Root Cause Analysis techniques such as 5 Whys, Ishikawa, Pareto, fault tree analysis, flow charts, process capability, histogram, 8D etc.)

　　Trackwise digital a plus.

　　FDA 21 CFR part 803 and 806 a plus

　　FDA CAPA remediation (preferred)

　　Experience guiding and/or mentoring an investigation team is required.

　　Knowledge, Skills and Abilities

　　Fundamental understanding of problem investigations (identification, scope determination, impact assessment, effectiveness verification, and remedial action)

　　Technical writing skills

　　Designing and writing procedures, flowcharting

　　Ability to collaborate cross-functionally.

　　Application of Quality Risk Management principles

　　Attention to detail (e.g. document reviews, investigation write ups).

　　High level of written and verbal communications skills

　　Ability to communicate with Statisticians and perform statistical calculations as needed.

　　Wisdom to seek help when needed.

　　Proficiency in MS Office tools, including Outlook, Word, and Excel

　　Developing and reporting Trends and Measures

　　Advanced Project management/leadership skills

　　Creating and giving training presentations

　　Mentoring peers and leading groups

　　Physical Requirements

　　Must be able to lift at least 25 lbs. and may be required to lift up to 50 lbs. Must be able to sit or stand for moderate amounts of time and look at computer monitors for an extended amount of time with or without accommodation.