Staff Quality Engineer

Posted 16 Days Ago
Be an Early Applicant
3 Locations
Mid level
Healthtech • Other • Robotics • Biotech • Manufacturing
Together with our customers, we're on a mission to make healthcare better.
The Role
Lead and provide technical guidance in quality assurance and control, focusing on continuous improvement of products and processes. Enhance quality performance initiatives, ensure regulatory compliance, and mentor across various expertise areas while managing multiple projects.
Summary Generated by Built In

Work Flexibility: Hybrid or Onsite

*Please note this is a 23 month Fixed Term Contract

- Onsite role

Position Summary

Provide quality engineering leadership and technical guidance in quality assurance, control, and preventative activities with a focus on continuous improvement of internal products and processes. Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers. Mentor and provide technical direction across multiple areas of expertise. Ensure compliance to regulation and standards. 

What you will do:

  • Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired 

  • Understanding of US and International Medical Device Regulations 

  • Familiarity with ISO 13485, GDP, GMP required 

  • Strong knowledge of Quality concepts (e.g. Risk Management, CAPA, Audits, Statistics) 

  • Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously 

  • Ability to represent Quality function within and across the project teams 

  • Strong interpersonal skills, written, oral communication and negotiation skills 

  • Strong in critical thinking and outside the box thinking 

  • Highly developed problem-solving skills,  

  • Strong analytical skills 

  • Demonstrated ability to successfully manage and complete projects in a matrix organisation 

  • Demonstrated ability to work independently and as part of cross functional teams 

  • Experience in working in a compliance risk situation 

  • Previous industry experience required 

  • Computer literacy 

  • Some travel may be required 

What you will need:

- Level 8 Degree- STEM subject

- 4 years experience required

Travel Percentage: 10%

The Company
HQ: Kalamazoo, MI
51,000 Employees
On-site Workplace
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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