Associate Quality Engineer

Key Responsibilities

• Provide Quality Engineering support to US Operations to ensure FDA/ISO compliance and act as first line support for quality issues.
• Quarantine and disposition non-conforming product.
• Initiate and own non-conformances, including root cause analysis.
• Participate in Material Review Board (MRB) meetings.
• Participate in or lead Corrective and Preventive Actions.
• Assist in preparing, reviewing and approving quality documentation, including SOPs and work instructions.
• Initiate and support Change Controls to update documentation and processes.
• Support complaint investigations.
• Identify and justify opportunities for quality and continuous improvement activities.
• Perform data analysis, write summary reports and other technical memoranda.
• Maintain applicable QMS instructions.
• Conform with Coloplast Code of Conduct and all local Compliance Standards.
• Conform with Coloplast Q/EHS Policy.
• Other duties as assigned.

Requirements & Tech Stack

• Bachelor’s degree in engineering or related field.
• 0-2+ years of related manufacturing or relevant work experience.
• Self-motivated and self-managed within a dynamic and collaborative team environment.
• Strong analytical and problem-solving skills.
• High performing individual that is able to accept challenges and opportunities as they arise.

Knowledge, Skills And Abilities

• Ability to work independently and with general direction.
• Excellent written & oral communication skills, strong technical writing skills.
• Computer skills – Microsoft Office Suite (Access, Word, Excel, PowerPoint).
• Strong decision-making skills.
• Strong problem-solving and trouble-shooting skills.
• Curious and eager to learn in a fast-paced, regulated industry.
• Ability to effectively interact with various internal and external customers/vendors.
• Ability to convey a positive and professional image to internal and external customers.
• Ability to multi-task and prioritize multiple projects.
• Ability to communicate and train cross-functionally at every level of the business.
• Understanding of FDA, QSMR, ISO 13485 and ISO 14971 requirements.