MedTech Quality & Continuous Improvement Engineer

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

Job summary

Stryker Ireland is seeking a Quality Engineer to provide quality engineering support across operations, QA, control and preventative activities, with a focus on proactive improvements to products and processes. You will advocate and lead initiatives to enhance quality performance, ensure compliance with regulatory standards, and partner with cross-functional teams.

Responsibilities include approving NCs, reviewing change management, maintaining KPI dashboards, supporting audits, and developing

Qualifications

• Engineering licence and 2 years work experience in a quality discipline.
• Engineering diploma (diplôme d'ingénieur) is required in some regions.
• Masters or Bachelor of Science, Engineering or related subject is preferred in applicable locales.
• Technician degree (or Level 6 like Meister) may satisfy regional requirements.
• Excellent English (oral and written) and strong communication skills.

Responsibilities

• Work closely with operations and the business functions to ensure quality performance of product and processes.
• Approval of NC, builds proficient in problem solving and root causing activities.
• Participate in the development and improvement of the manufacturing processes for existing and new products.
• Review of change management activities.
• Maintain KPIs for monitoring of process quality, perform analysis and interpret trends, take action as necessary.
• Support execution and analysis of QATs.
• Advocate of Human Factor practices, familiarity in the science of Human Factor identification, reduction and mitigation.
• Develop understanding of risk management practices and concepts, ability to become proficiency in process risk.
• Develop understanding of optimization of inspection methods and sampling. Support First Article Inspections.
• Developing proficiency in statistical methods and application.
• Participate and interface in internal audits providing effective narrative and description of topic of expertise, participate in external audits preparation building confidence and proficiency in interactions with same.
• Assist in the development and review of process and equipment validation/qualification. Build proficiency in validation processes.
• Support manufacturing transfers to other plants/facilities, execution quality activities.
• Responsible for initiation, internal containment and support of ship and product holds for potential product escapes.

Skills

Excellent communication skills

Attention to detail

Problem solving

Analytical skills

Team player

PC skills

Education

Master's or Bachelor of Science in Engineering or related subject

Engineering/Science licence (France)

Engineering diploma (diplôme d'ingénieur)

Masters or Bachelor of Science in Engineering or related subject (Ireland/NA)

Technician degree (Meister Level 6)

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Stryker Ireland is seeking a Quality Engineer to provide quality engineering support across operations, QA, control and preventative activities, with a focus on proactive improvements to products and processes. You will advocate and lead initiatives to enhance quality performance, ensure compliance with regulatory standards, and partner with cross-functional teams.

Responsibilities include approving NCs, reviewing change management, maintaining KPI dashboards, supporting audits, and developing