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We hope that through this challenging time, you and your family are staying safe and healthy. Though the COVID-19 pandemic is presenting unprecedented challenges, we continue to hire for our open positions. Our recruiting and hiring teams are taking prudent measures to minimize the spread of COVID-19 and still provide you with a great candidate experience. However, due to adjustments in work, life, and an increase in applications, we may start to experience some delays. Thank you for your patience and understanding.

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Senior Manager Quality Operations

Job Description

Job: Manufacturing & Operations
Primary Location: Germany-Baden-Württemberg-Emmendingen
Schedule: Full-time
Requisition ID: 200453

Description

Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.

 

Primary Function of Position:

Manage Quality Operations for Intuitive’s manufacturing facility in Emmendingen. Primary functional responsibilities include the areas of Incoming Quality Control (IQC), Material Review Board (MRB), Preventive Maintenance Calibration (PMC) and Product Release (DHR), to ensure adherence to company quality standards. The Quality Manager will directly support all audit related activities both internal and external for the Emmendingen facility. This role will work directly with plant leadership to align on goals and objectives. The Quality Manager will lead continuous improvement activities within the Quality Operations team.

 

Roles and Responsibilities:

  • Manage the Quality Operations team (IQC/MRB/PMC/DHR functions)
  • Assure all operations are performed in accordance to procedures
  • Perform periodic audits to verify correct and consistent operations
  • Determine, maintain Quality Operations CIP/department goals
  • Track recurring issues and escalate as needed to achieve root cause corrective action
  • Interface on a daily basis with internal customers to provide status of open issues and drive those items to closure.
  • Drive cross-functional issue resolution
  • Facilitate interdepartmental resource allocation
  • Develop, trend, and improve appropriate metrics
  • Handle materials in accordance to procedures, and maintain traceability of component materials as to inspection status
  • Proactively recognize environmental changes and provide coordinated direction for mitigation
  • Drive improvements in safety, production, quality, cost, and delivery
  • Allocate resources appropriately to achieve departmental objectives
  • Perform periodic capacity analysis in order to support production growth
  • Develop leadership personnel within the department in order to support growth
  • Write and conduct formal annual performance reviews for staff
  • Develop and manage departmental budget


Qualifications

Required Knowledge, Skills, and Experience:

  • BS degree and 10 years of working experience
  • Leadership experience at least of 3 years
  • Outstanding management, leadership and communication skills
  • Knowledge of RE-Manufacturing processes desirable
  • Knowledge of returned material decontamination processes desirable
  • Must be familiar with all standard inspection tools, gauges, optical comparators and various types of coordinate measuring machines effectively
  • Must be computer literate with experience using; Windows, Excel, Word, Powerpoint
  • Good understanding of Inspection (GD&T), Metrology, PMC, and GMP
  • Must have a working knowledge of MRB related activities.
  • Experience in Medical Device industry and knowledge of Good Manufacturing Practices
  • Working knowledge of quality tools: measurement repeatability systems, process control tools (Statistical Process Control)
  • Excellent creative problem-solving skills
  • Excellent communication and documentation skills in German and English
  • Working knowledge of Lean / Six Sigma