Senior Manufacturing Transfer Quality Engineer

Responsibilities:

• 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 specialty 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

Requirements:

• Bachelor's Degree in Engineering, Science or related submitted
• 2+ years of experience in validation and/or quality
• 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