Job Description
Who we Want:
Detail-oriented process improvers . Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize and automate.
Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues
What you will do:
Leads Global Security Risk and Compliance (GSRC) process improvements as they relate to the IT Quality Management System (QMS) and supporting functions. Manages the Corrective and Preventive Action (NC/CAPA) process for Global IT. Supports the development and administration of IT SLMS training curricula. Participates in other GSRC processes and/or initiatives as needed.
Recommends improvements to re-design and streamline processes as they relate to the IT QMS and supporting functions. Facilitates and drives implementation plans to support GSRC initiatives.
Serves as the NC/CAPA specialist for it to open, track, approve and close IT non-conformances
Drive the processing of NCs/CAPAs to closure to meet established timelines and targets; liaise with relevant functional groups, facilitate and mentor teams through all stages of the NC / CAPA process
Evaluates and escalates non-conformances to Corporate Quality where there is product quality impact
Performs analysis to identify trends across NCs that indicate systemic issues
Partners with QMS Process Owners and others appropriate to identify appropriate training curricula for Global IT team members; Performs SLMS administration for IT as appropriate
Develops and/or refines metrics related to GSRC Quality Management processes and initiatives.
Participates in IT ISO certification audits and/or audit preparation activities
May develop and/or revise GSRC procedures, training programs and materials, and/or GSRC Quality Management process metrics where appropriate
May participate in other GSRC processes and initiatives as required
What you need:
Bachelor of Science degree or relevant work experience is required
Minimum of 4 years of experience working in a regulated industry (preferably Life Sciences and Medical Devices) or equivalent experience in Banking or Government agencies
Minimum of 4 years of experience working in Quality organization
Working knowledge of industry standard frameworks (e.g., ISO 9001/27001/20000) preferred
Demonstrate strong stakeholder management experience in matrix organizations required
Work Location (Hybrid): You will need to live within commuting distance to our Portage, MI or Allendale, NJ office. You will need to be in the office 1-2 days a week, but you will have the flexibility to work from home on the other days.