Engineer, Post Market Quality

Stryker Group; Carrigtwohill; On-site; EUR 40,000 - 67,000; Full time

Job summary

Stryker Ireland Carrigtwohill is seeking a Post Market Quality Engineer to provide quality assurance, control, and preventive activities, driving continuous improvement and ensuring compliance with US and international medical device regulations.

You will work with customers and cross-functional teams, manage CAPAs, audits, risk management, and problem solving, with travel possible; BS required and 0+ years experience.

Qualifications

• BS in science/engineering or related discipline.
• 0+ years experience in Quality Management Systems.
• Experience liaising with regulatory agencies (FDA, MoH, TUV) desired.
• Understanding of US and International Medical Device Regulations.
• Familiarity with ISO 13485, GDP, GMP desired.
• Knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).
• Strong communication, project management and influencing skills.
• Ability to manage multiple tasks in a matrix organization.
• Represent Quality with project teams; strong written/oral skills.
• Some travel may be required.

Responsibilities

• Work 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 and analyze trends for quality improvement.
• Support complaints and product field actions.
• Advocate Human Factor practices and risk management concepts.
• Develop understanding of inspection method optimization and sampling.
• Apply statistical methods and analysis.
• Engage in internal audits and support external audits.
• Initiate containment and support of holds for potential product escapes.

Skills

Quality management

Regulatory experience

Problem solving

Project management

Communication skills

Cross-functional teamwork

Audits

Risk management

Statistics

Analytical thinking

Education

BS in science/engineering or related discipline

Job description

***12 month fixed term contract*** -

Hybrid, Carrigtwohill

Post Market Quality Engineer

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 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 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.

Ireland Pay Ranges:

• Ireland: €40,000 - €67,000 EUR Annual

At Stryker, we believe transparency helps candidates make confident decisions about their next career step. Compensation is an important part of that process and we want to be clear about how pay is determined. The compensation information posted for this role may be presented as a salary range or a fixed amount depending on the role. In addition to base salary, this role may be eligible for incentive compensation (such as bonus and/or commissions where applicable), along with Stryker’s comprehensive benefits package.

If you’d like to learn more about the salary or the benefits associated with this role, your recruiter will be happy to walk you through the details as you progress through the hiring process.