Quality Engineer (1 year contract)

• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvements across the business.
• Analytical problem solvers. People who go beyond, by identifying root causes, evaluating optimal solutions, and recommending comprehensive solutions to prevent future issues.

• Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
• Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.

• Implement inspection plans for components and finished goods within the designated project to ensure product quality and adherence to project requirements.
• Perform MSA (Measurement Systems Analysis) studies as needed for the implementation of inspections, specifically tailored to the project's parameters and objectives.
• Provide support for resolving quality issues encountered during the project, addressing them promptly to maintain project timelines and deliverables.
• Maintain and update standard quality system procedures based on continuous improvement activities, customer feedback, trend analysis of KPIs, and preventive and corrective actions specific to the project.
• Lead and participate in both internal and external quality system audits related to the project, ensuring compliance, and identifying areas for improvement.
• Ensure accurate identification of product status, including segregation and identification of nonconforming products at each step of the processes within the project framework.
• Ensure compliance of processes and products with GMP (Good Manufacturing Practices) and relevant regulatory requirements applicable to the project.
• Collaborate in internal quality system audits, focusing on project-related processes and procedures.
• Lead or participate in team efforts to deploy and implement quality and process analysis tools or systems such as PFMEA, control plans, R&R, PDCA, RCA, SPC, Cpk, etc., tailored to the needs of the project.
• Lead and participate in projects aimed at updating and improving the quality system specifically for the project's objectives and requirements.
• Participate in the follow-up and approval of product and process changes within the project scope, including IQ, OQ, and PQ activities.
• Collaborate in general continuous improvement activities related to the project, contributing ideas and efforts to enhance project outcomes.
• Lead or participate in change control management meetings specific to the project, including document control, master validation plans, and NPI discussions.
• Ensure the accuracy and timely inspection/calibration of monitoring and measuring devices used within the project.
• Oversee the inspection of incoming materials for the project, ensuring they meet specified requirements and project standards.
• Lead the opening and closure of CAPAs specific to the project, ensuring effective and timely responses for each stage and compliance with project-specific CAPA procedures and relevant regulatory requirements.

• Bachelor's degree in engineering is required
• ASQ CQE or six sigma GB certification preferred
• Minimum of 3 years of experience in similar roll in a medical device manufacturing environment required.
• Considerable experience of quality systems for medical devices.
• Proficient in MS Office Suite (including Word, Excel and Power Point)
• Excellent communication skills
• CFR 820 and applicable regulatory requirements
• ISO 13485
• Minitab and Microsoft
• Conversational & Written English is required

Stryker