Quality Engineer - Arden Hills, United States - Insight Global
Description
Your Responsibilities Will Include:
• Co-Ordinate project activities with teams, communicate progress, collaborate on key deliverable, and meet critical phase timelines.
• Providing continuous and rigorous assessment of Material Controls processes to ensure compliance with FDA regulations, ISO 13485, and Medical Device Requirements and applicable global regulations.
• Ownership of highly visible, global, systemic CAPAs.
• Determining and tracking actionable material controls metrics to improve supply chain effectiveness, product quality and patient outcomes.
• Support information gathering and preparation activities for applicable Global Quality System meetings and forums (e.g. audits, signals reviews)
• Facilitate change management with cross functional groups (Supplier Quality, Purchasing, Sourcing, IT and Analytic Teams).
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to the position responsibilities.
• Act as an effective leader or team member in supporting quality disciplines, decisions, and practices.
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
What We're Looking For In You:
Required Qualifications
• Bachelor's degree in life science, Quality or Engineering field.
• Proven experience (2-4 years) in manufacturing, quality, IT or regulatory/compliance environment.
• Excellent verbal / written communication, interpersonal, project management, organizational and analytics skills.
• Experience working in an FDA and ISO 13485 environment and an understanding of quality system requirements as stated within 21 CFR Part 820 and ISO 13485.
• Must be proactive and be a contributing member of a highly visible team.
• Occasional travel may be required to support and facilitate workshops