KIK Custom Products

Quality Project Manager (Divisional)

Job Location US-IL-Rosemont
Posted Date 3 weeks ago(1/29/2018 12:21 PM)
Job ID
2018-4983
# of Openings
1
Division
KCM

Overview

Custom New Logo

 

The Division Quality Project Manager will support the Quality Team by orchestrating all aspects of Quality projects. Position works closely with the Quality Systems Manager, KIK Custom Products, KCM plants and divisional resources. The individual must have a high energy level necessary to thrive in a fast paced environment and have a good balance of people skills, urgency, understanding and a positive team-work focus.

Essential Job Functions

  • Assist in the development of tools and processes needed to ensure large projects have robust oversight and are designed to achieve Quality objectives.
  • Implement processes designed by Quality Systems Manager including changes to Quality Systems and their validation; including IT projects such as LIMS, eQMS, etc.
  • Builds appropriate project plans for assigned projects while ensuring that all necessary work streams are defined, participants are engaged, actions are clearly defined and action owners are held accountable to expectations.
  • Apply a disciplined approach to using tools, managing timelines, keeping team members engaged and on track.
  • Controls scope creep and manage change control process and where possible, anticipates problems that may occur and take early preventative action.
  • Assist in defining best practices among sites and ultimately work to building standardized process and tools that all KIK sites can adopt to bring consistency in how each site manages quality activities.
  • PM for Divisional CAPAs and Divisional Quality Projects.
  • Responsible for Divisional Quality Scorecards and reporting; including presentation of data to management in accordance with Management responsibility procedure.
  • Support and assure organizational process and product compliance.

Qualifications

  • Bachelor degree (or higher) in area of discipline.
  • Minimum 5+ years’ project management experience in Quality is required.
  • Minimum 5+ years’ experience in FDA regulated manufacturing environment and experience in personal care, OTC, medical device, or pharmaceuticals manufacturing is required.
  • Project Management experience implementing new or revised quality systems and processes including LIMS and eQMS.
  • Knowledge of national and international regulations applicable to medical devices including; Quality System Regulations, 21 CFR 820, 21CFR 803 and 804 (MDR regulations), Canadian Medical Device Regulations, ISO 14971, ISO 13485, and MDD 93/42/EEC.
  • Strong analytical and quantitative skills including ability to build and manage large scale Microsoft project plans, manage project risks and maintain project documentation.
  • Travel to division sites is expected as necessary.
  • Lean Six Sigma certifications/experience preferred.
  • Experience in post market quality assurance, including risk evaluation preferred.

 KIK is an Equal Opportunity / Affirmative Action Employer

 

www.KIKCORP.com

 

www.KIKCUSTOM.com

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