Quality 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

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

• 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.

France

• Engineering/Science licence and 2 years work experience in a quality discipline or
• Engineering diploma (diplôme d'ingénieur)

Germany / Switzerland

• Masters or Bachelor of Science, Engineering or related subject
• Technician degree (or similar Level 6 Education like Meister)

Ireland / North America

• Masters or Bachelor of Science, Engineering or related subject
• Previous experience in industry desirable
• Understanding of Med Device concepts desirable.
• Familiarity with ISO 13485, GDP, GMP concept desirable.
• Excellent communication skills and attention to detail.
• Have a good understanding of engineering and quality concepts / theories.
• High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
• Self-starter with efficient work style and ability to handle multiple tasks in a fast paced environment.
• Must be willing to work as part of a multi-site team, with some travel required.
• Knowledge of Risk Based and statistical concepts desirable.
• Problem solving and analytical skills.
• Builds strong relationships by fostering open communications, respect and trust. Strong team player and acts with a customer service/stakeholder focused approach
• Is diplomatic, tactful and leverages excellent interpersonal keys to help achieve outcomes.
• Accepts change openly and adopts a continuous improvement orientation to the role
• Excellent English (both oral and written)
• Ability to be the voice of Quality when dealing cross functionally

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. 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 150 million patients annually.