Engineer, Post Market Quality

Stryker Corporation; Ireland; On-site; Confidential; Full time

Job summary

Stryker is seeking a quality engineer to support QA, control, and preventative activities with a focus on continuous improvement of products and processes. You will lead initiatives to enhance quality performance and ensure compliance with regulatory standards and ISO guidelines.

Responsibilities include collaborating with cross-functional teams, reviewing change management, maintaining KPIs, and supporting field actions while advancing human factors and risk management practices.

Qualifications

• BS in a science, engineering or related discipline.
• 0+ years experience in Quality Management Systems.

Responsibilities

• Work closely with customers and cross-functional teams to address top quality issues.
• Approve NC/CAPA and perform root-cause analysis.
• Review change management activities.
• Maintain KPIs, analyze trends, and take action as needed.
• Support execution of complaints and product field actions.
• Advocate Human Factor practices and risk management concepts.
• Understand optimization of inspection methods and sampling.
• Develop proficiency in statistical methods and applications.
• Interface in internal audits and support external audit preparation.
• Initiate internal containment and support ship/product holds for potential escapes.

Skills

Strong communication

Project management

Influencing skills

Critical thinking

Analytical skills

Cross-functional teamwork

Negotiation skills

Independent worker

Problem solving

Computer literacy

Education

BS in science/engineering

Job description

Position Summary

Provide quality engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement of products and processes. Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers. Ensure compliance to regulation and standards.

Key Areas of Responsibility

• Work closely with customers, sales/marketing/field personnel, and cross-functional teams to address top quality issues.


• Approval of NC/CAPA, builds proficiency in problem-solving and root-causing activities.


• Review of change management activities.


• Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, take action as necessary.


• Support execution and analysis of complaints and product field actions.


• Advocate of Human Factor practices, familiarity in the science of Human Factor identification, reduction, and mitigation.


• Develop understanding of risk management practices and concepts.


• Develop understanding of optimization of inspection methods and sampling.


• Develop proficiency in statistical methods and application.


• Engage and interface in internal audits providing effective narrative and description of topic of expertise, participate in external audit preparation building confidence and proficiency in interactions.


• Responsible for initiation, internal containment, and support of ship and product holds for potential product escapes.

Education / Work Experience

BS in a science, engineering or related discipline. 0+ years experience in Quality Management Systems Knowledge / competencies.

Previous Industry Experience

Desired. 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 desired.

Knowledge

• Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).

Skills

• 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 with project teams.


• Strong interpersonal skills, written, oral communication and negotiations 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 organization.


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


• Computer literacy.


• Some travel may be required.

Contract Type and Work Hours

12 month fixed term contract. Hybrid or Onsite. Hybrid, Carrigtwohill.

Salary

Pay Ranges: Ireland: €40,000 - €67,000 EUR Annual

Travel

Travel Percentage: 10%

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with its 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!

For more information, visit: www.stryker.com

Work Flexibility

Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location.

Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based.

Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category.

Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.