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This is a 23-month fixed-term contract based in Carrigtwohill.
Position Summary: Provide quality engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement of internal products and processes. Support supplier quality issues impacting daily operations. Advocate and lead initiatives to enhance quality performance within the business and for customers. Mentor and provide technical direction across multiple areas. Ensure compliance with regulations and standards.
General Requirements:
* Experience 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 (Risk Management, CAPA, Audits, Statistics)
* Excellent communication, project management, and influencing skills; ability to manage multiple tasks
* Ability to represent the Quality function within and across project teams
* Strong interpersonal, written, oral communication, and negotiation skills
* Critical and outside-the-box thinking
* Problem-solving and analytical skills
* Experience managing projects in a matrix organization
* Ability to work independently and in cross-functional teams
* Experience in compliance risk situations
* Previous industry experience required
* Computer literacy
* Some travel may be required
Key Areas of Responsibility:
* Collaborate with operations and business functions to ensure product and process quality
* Work with QA, cross-functional, and supplier teams to address quality issues
* Manage internal and supplier non-conformances and CAPAs
* Disposit non-conforming products within MRB, issue NCs as needed
* Communicate with suppliers regarding non-conformances and escalate as necessary
* Improve internal manufacturing processes
* Assess change management activities and perform PPAP for supplier changes
* Review and create procedures
* Monitor KPIs, analyze trends, and implement actions
* Support manufacturing complaints and field actions
* Implement Human Factors practices
* Identify and execute supplier part certification opportunities
* Apply risk management concepts to manufacturing
* Maintain inspection methods and sampling
* Use statistical analysis and process control
* Support audits and validation activities
* Manage quality during engineering changes and manufacturing transfers
* Lead or support product containment and quality improvements
* Provide QA leadership and expertise across the site
Qualifications:
* BSc in science, engineering, or related field
* MS, CQE, or CRE preferred
* Six Sigma Green or Black Belt preferred
* Minimum 4 years’ industry experience preferred
Stryker is a global leader in medical technologies, impacting over 150 million patients annually through innovative products in MedSurg, Neurotechnology, Orthopaedics, and Spine.
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