Supplier Quality Controls Engineer (12 Month Contract)

Posted 4 Days Ago
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Warsaw, Warszawa, Masovian
Entry level
Healthtech • Other • Robotics • Biotech • Manufacturing
Together with our customers, we're on a mission to make healthcare better.
The Role
The Supplier Quality Engineer leads supplier quality controls and process improvements, collaborating with various teams to enhance supplier quality systems and compliance.
Summary Generated by Built In

Work Flexibility: Hybrid

What you will do:

The Supplier Quality Engineer serves as a key role for leading supplier quality controls activities and process improvement initiatives at Stryker sites. In this role, you will interface with many functions of the business and own the development and continuous improvement of global supplier quality controls systems, tools, policies, and procedures at assigned Stryker sites across the globe.
The Supplier Quality Engineer focuses on developing processes that build quality into the products we sell and driving a culture of continuous improvement to support Stryker’s mission & strategic goals.
Additional responsibilities include:

  • Responsible for the development, revision, maintenance, and inactivation of the local Stryker site procedures ensuring the alignment with the corporate guidelines for purchasing controls.
  • Partner with Procurement, Site Quality, Regulatory, and Regional Supplier Quality teams on strategic initiatives and sustaining activities to support successful supplier quality controls programs.
  • Support tracking and reporting of KPI and other metrics associated with supplier performance. Articulate detailed supplier performance results and trends to appropriate levels of management.
  • Support Third Party inspection (FDA, Notified Body etc.) and Stryker Corporate audits of the quality system.
  • Execute supplier quality agreements (SQA) and Supplier Change Control Agreements (CCA)
  • Provide best in class support to our business partners across Stryker for successful implementation of compliant and efficient Supplier Quality Controls programs.
  • Contribute to initiatives for improvement and implementation of processes, to build a best in-class Supplier Quality Controls organization.
  • Work with site and divisional counterparts to own Corporate Purchasing Controls NC’s and CAPA’s (containment actions, root cause, corrective/preventive action, etc.).
  • Additional duties, as assigned.

What you need

Basic Qualifications:

  • Bachelor’s degree in a science, engineering or related discipline preferred, or equivalent years of experience.
  • 0+ years of experience in manufacturing environment or equivalent.

Preferred Qualifications:

  • Bachelor’s degree in engineering preferred.
  • Experience in quality management systems.
  • Expereince in project managemnt.
  • Supply Chain and/or Medical Device quality certifications or training.
  • ISO 13485 Lead Auditor certification or equivalent.
  • Knowledge of ISO 13485, FDA, EUMDR and regional medical device regulatory requirements.
  • Ability to effectively communicate information to team members, leaders, management, and suppliers.
  • Experience supporting third-party inspection (FDA, Notified Body etc.) within the medical device industry.

Travel Percentage: 10%

Top Skills

Eumdr
Fda
Iso 13485
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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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