Staff Quality Engineer (m/f/d) New Product Introduction

Reposted Yesterday
Be an Early Applicant
Freiburg, Baden-Württemberg
In-Office
Senior level
Healthtech • Other • Robotics • Biotech • Manufacturing
Together with our customers, we're on a mission to make healthcare better.
The Role
The Staff Quality Engineer will support new product introductions by executing quality assurance and design control activities while overseeing risk management and compliance with development procedures.
Summary Generated by Built In
Work Flexibility: Hybrid or Onsite

As a (Sr) Staff Quality Engineer (m/f/d) NPI New Product Introduction at Stryker you will have an incredible opportunity to support the introduction of new, innovative medical devices and help improving the lives of patients around the globe.

Your key responsibilities

  • As a (Sr) Staff Quality Engineer (m/f/d) NPI you will execute design for manufacture and assembly through technical understanding of quality assurance, design control and preventative activities.

  • You will support the development and introduction of new products, processes, and technologies, with focus on risk management

  • You will provide quality engineering support for the execution of quality assurance activities during design transfer phases of new product development.

  • You will provide Quality engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with the Stryker new product development procedures.

  • You will support (international) projects within multiple sites

What are we looking for?

Required:

  • You have completed B.S in Engineering or related subject.

  • You have a minimum of 6 years’ experience in a regulated environment within a manufacturing environment (Medical Device is an advantage). Depending on your experience, the level of seniority may vary.

  • You bring over 4 years of experience in quality assurance or process management within a manufacturing or production environment.

  • You have good problem solving and communication skills, as well as attention to detail.

  • Your excellent English and German language skills enable you to collaborate with stakeholders on a global basis.

Preferred:

  • You are familiar with Qualification & Validation in regulated environment OR you are knowledgeable in CSV (Computer System Validation).

Diversity is important to us. We welcome applications from people regardless of their ethnic, national or social origin, gender, disability, age or sexual identity

Additional Info:

This role is initially limited to 24 months.

The external job posting title may differ from internal business title.

Travel Percentage: 10%

Top Skills

Computer System Validation (Csv)
Design Control
Medical Device Manufacturing
Process Management
Qualification & Validation
Quality Assurance
Risk Management
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The Company
HQ: Kalamazoo, MI
51,000 Employees
Year Founded: 1941

What We Do

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at www.stryker.com.

Together with our customers, we are driven to make healthcare better.

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