Senior Quality Engineer

Stryker Group; Carrigtwohill; On-site; EUR 50,000 - 70,000; Full time

Job summary

Stryker Group in Carrigtwohill, Ireland, seeks a quality assurance professional for a 23-month fixed-term contract, fully onsite. You will provide quality engineering support, oversee NC/CAPA, drive process improvements, and ensure compliance with ISO 13485, GMP/GDP standards within a multi-site, fast-paced manufacturing setting.

You will collaborate with operations and regulatory teams, analyze trends, and mentor others in quality topics while maintaining KPI dashboards and risk-based quality

Qualifications

• Bachelor degree in Science, Engineering or related subject with 2+ years in quality.
• Lean Six Sigma training is advantageous.
• Experience in regulated medical device environments is desirable.
• Strong communication and attention to detail.

Responsibilities

• Collaborate with operations to ensure product/process quality.
• Oversee NC & CAPA activities and assist in root-cause analysis.
• Lead manufacturing process improvements for existing/new products.
• Review change management and conformance to regulatory standards.
• Maintain KPIs and analyze trends to drive corrective actions.
• Support QAT execution and risk-based quality practices.

Skills

Analytical thinking

Attention to detail

Communication

Education

Bachelor's degree in Science/Engineering

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

23-month fixed term contract

Fully onsite in Carrigtwohill

Provide quality engineering support and direction 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.

Will work within the quality operations team, under minimal supervision, with responsibility for quality related activities, including, but not limited to the following:

• Work closely with operations and the business functions to ensure quality performance of product and processes.
• Oversight and approval of NC & CAPA, activist and mentor in problem solving and root causing activities.
• Lead and participate in the development and improvement of the manufacturing processes for existing and new products.
• Analysis and review of concession requests.
• Review and approval of change management activities.
• Maintain KPI 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, proficient in the science of Human Factor identification and mitigation.
• Proficient in risk management practices and tools, having high expertise in process risk. Develop and provide input for risk management by identifying opportunities and weaknesses.
• Proficiency in and makes continuous strides towards optimization of inspection methods and sampling. Support First Article Inspections.
• Proficiency in statistical methods and application.
• Participate and interface in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise.
• Assist in the development, responsible for review & approval of process and equipment validation/qualification.
• Support manufacturing transfers to other plants/facilities, leading quality activities.
• Responsible for initiation, management and support of Ship, Product Holds, potential product escapes.
• Coach and mentor others in quality topics and activities.

Qualifications Knowledge Skills

• Bachelor degree in Science, Engineering or equivalent/ related subject and 2 or more years of work experience in a quality discipline.
• Previous experience in a regulated environment desirable.
• CQE or equivalent course work / experience desirable.
• Proficient in understanding of Med Device manufacturing processes desirable.
• Familiarity with ISO 13485, GDP, GMP desirable.
• Lean Six Sigma training a distinct advantage.
• Excellent communication skills and attention to detail.
• Have a good understanding of engineering and quality practices & methods.
• High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
• Self-starter with demonstrated efficient work methods, analytical & problem solving skills 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.
• Working knowledge/experience of Risk Based and statistical techniques, in particular process risk, statistical sampling plans, Process Capability, Gauge R&Rs.
• Highly developed problem solving and strong 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.
• Manages change well 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.