Senior Quality Engineer

Overview

Senior Quality Engineer position at Stryker in Limerick, County Limerick, Ireland.

12 Month FTC.

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 and projects to enhance quality performance within the business.

Ensure compliance to regulation and standards.

Responsibilities

Work closely with operations and the business functions to ensure quality performance of products and processes.

Approve non-conformances, build proficiency in problem solving and root cause analysis.

Participate in the development and improvement of manufacturing processes for existing and new products.

Review change management activities.

Maintain KPIs for monitoring process quality, perform analysis and interpret trends, and take action as necessary.

Support execution and analysis of Quality Assurance Tests (QATs).

Advocate human factors practices, familiarity with human factor identification, reduction and mitigation.

Develop understanding of risk management concepts and pursue proficiency in process risk.

Develop understanding of optimization of inspection methods and sampling.

Support First Article Inspections.

Develop proficiency in statistical methods and their application.

Participate in internal audits and assist with external audits preparation, building confidence in interactions.

Assist in the development and review of process and equipment validation / qualification.

Build proficiency in validation processes.

Support manufacturing transfers to other plants / facilities, executing quality activities.

Take responsibility for initiation, internal containment and support of ship and product holds for potential product escapes.

Qualifications

Masters or Bachelor of Science in Engineering or related subject.

Previous experience in industry desirable.

Understanding of Medical Device concepts desirable.

Familiarity with ISO 13485, GDP, GMP concepts desirable.

Excellent communication skills and attention to detail.

Strong understanding of engineering and quality concepts / theories.

High level of PC skills; proficient with Microsoft Word, Excel and PowerPoint.

Self-starter with efficient work style and ability to handle multiple tasks in a fast-paced environment.

Willingness 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 through open communication, respect and trust.

Strong team player with a customer service / stakeholder focus.

Diplomatic, tactful, and able to facilitate cross-functional outcomes.

Open to change with a continuous improvement mindset.

Excellent English (oral and written).

Ability to be the voice of Quality in cross-functional interactions.

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