Staff Manufacturing Transfer Quality Engineer - Remote

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com

Stryker is hiring a Staff Manufacturing Transfer Quality Engineer - Remote. This job may be performed remotely from anywhere in the United States, except that this job may not be filled or performed in Colorado.

Who we want:

• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

What you will do:

The Manufacturing Transfer Quality Engineering function enables successful transfers by driving quality, cost transformation and service improvements for our customers whilst remaining compliant to both internal and external standards. In this role, you will work within the QA Shared Services Manufacturing Transfer Team and be responsible for quality related activities as it applies to Manufacturing Transfer, these include but not limited to the following:

• Supporting all transfers globally, (Supplier to Supplier, Supplier to Stryker, Stryker to Supplier, Stryker to Stryker)
• Having knowledge of and ability to provide interpretation and guidance on Regulations, Corporate and Site Local procedures as they relate to quality activities such as FMEA, MSA’s, Validations and Qualifications.
• Reviewing and approving of Validation/Qualification Documentation.
• Point of contact for quality for manufacturing transfers at Scoping, Planning and Execution phases
• Enable successful completion of manufacturing transfer to achieve its quality, cost and time requirements
• Provide expertise for at least 1 quality speciality associated with manufacturing transfer
• Be able to identify MT quality risks/gaps and provide solutions to correct
• Manufacturing Transfer Independent Reviewer as required
• Supports Manufacturing Transfer Process training where required
• Provides feedback to lessons learnt for each completed manufacturing transfer
• Drive continuous optimization of Manufacturing Transfer Process

What you will need:

Basic Qualifications:

• Bachelor’s Degree in Engineering, Science or related
• 4+ years of experience in validation and/or quality

Preferred Qualifications:

• Master’s Degree Preferred
• IQ/OQ/PQ process validation experience highly preferred
• Excellent communication skills and attention to detail.
• Have a good understanding of engineering and machine tool fundamentals.
• Strong knowledge of Quality Concepts and Risk Based Techniques (e.g. FMEA, Risk, Statistics).
• High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
• Self-starter with demonstrated efficient work methods, analytical & problem-solving skills and ability to handle multiple tasks in a fast paced environment.
• Continuous Improvement Mindset
• Lean Six Sigma training a distinct advantage.
• Must be willing to work as part of a multi-site team, be able to travel as part of the job

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