Essential Duties and Responsibilities
Contribute to the development and implementation of quality management programs focusing on continual improvement across various processes.
Create processes to better evaluate, track and trend audit outputs and identify risks/issues and evaluate impact on global quality systems and initiate actions, as needed.
Coordinate communication between internal teams.
Regularly analyze data trends, drive improvements and meet customer expectations through efficient reporting and communication.
Reviews, revises, and creates operating procedures to ensure compliance with all related external requirements, internal procedures or instructions, and the West Quality Manual.
Ability to lead meetings with relevant teams, employees and contractors as necessary to manage changes.
Establishes monthly KPIs and metrics to Quality Leadership.
Drive continuous quality improvement projects across the enterprise for increased compliance and to create efficient use of company resources.
Leading personnel responsible for calibration activities monitoring, calibration reports approvals. Responsible for calibration specifications approval and for reviewing and approving calibration deviations.
Lead the sites device sterilization methods establishment, validation, maintenance and routine controls as the site sterilization SME by verifying that the sterilization methods validation is done according to the applicable standards and regulations. Verify the sterilization methods and risk-based approach are routinely maintained. Address sterilization issues and provide solutions to sterilization challenges. Be a part of the West Global Sterilization Council and provide support to other West CM and Medical device sites with Sterilization issues. Be key focal point with the West IL sterilization service providers related to sterilization matters.
Independently performs supplier audits and corporate facility audits.
Travel Requirements:
20%: Up to 52 business days per year.
Education:
Bachelor's Degree In Engineering or Science required and
Master's Degree In Engineering or Science preferred.
Work Experience:
Minimum 5 years Experience in regulated Quality Assurance / Document/Configuration Control (or a formal education equivalent) required and
Experience with Medical Device Product Development Life Cycle Activities, Verification / Validation Activities, Risk Management, DHF Activities preferred and
Experience with quality systems such as ISO 9001, ISO 15378 and ISO 13485, 21 CFR 820 preferred and
Experience Leading Internal / External Audits, MasterControl, SAP and Share Point preferred and
Experience with customer interface and meeting customer expectations preferred.
Preferred Knowledge, Skills and Abilities:
Ability to work independently, multi-task and thrive in fast-paced environment.
Excellent written and verbal communication skills.
Proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point.
Proven knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) ISO 13485.
Familiarity with root cause analysis tools.
Working knowledge of MasterControl and SAP.
Support and contribute in Lean Sigma programs and activities towards delivery of the set target.
Ability to make and implement decisions based on experience and facts as well as provide direction to peers or less experienced team members.
Able to be aware of all relevant SOPs as per Company policy and Quality Manual.
Able to comply with the companys safety policy at all times.
