Quality Engineer

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

Job summary

Stryker is hiring a quality engineering professional to provide QA/QC support within operations and related functions. The role emphasizes preventative measures and continuous improvement of products and processes.

You will lead initiatives to enhance quality performance, support audits, change management reviews, and monitor process KPIs while collaborating across multi-site teams in Ireland and beyond. Strong English communication and MS Office skills are essential.

Qualifications

• Engineering/Science degree with 2 years in quality discipline (France), or
• Masters/Bachelor in Engineering; capable of problem solving and root cause analysis.
• Experience with ISO 13485, GDP, GMP concepts is desirable.

Responsibilities

• Provide quality engineering support for QA/QC activities and ongoing improvements.
• Approve NCs and engage in root cause analysis and problem solving.
• Review change management and monitor process quality KPIs.
• Support QATs, audits, and validation/qualification activities.

Skills

Communication skills

Attention to detail

Problem solving

Analytical skills

Quality concepts

MS Office proficiency

Cross-functional collaboration

Education

Masters or Bachelor of Science in Engineering or related

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.