Senior Engineer, Quality

Stryker; Carrigtwohill; On-site; EUR 47,000 - 77,000; Full time

Job summary

Stryker Ireland seeks a quality engineer to provide quality support and direction within operations, focusing on preventative actions and continuous improvement of products and processes. You will lead NC & CAPA activities, participate in audits, and drive process improvements while ensuring regulatory compliance.

The role requires collaboration with operations, risk management proficiency, and strong problem-solving skills.

Qualifications

• Bachelor degree in Science, Engineering or related subject.
• 2+ years of work experience in quality discipline in a regulated environment desirable.
• CQE or equivalent coursework/experience desirable.
• Familiarity with ISO 13485, GDP, GMP desirable.
• Lean Six Sigma training a distinct advantage.
• Excellent communication skills and attention to detail.
• Good understanding of engineering and quality practices & methods.
• High level of PC skills: Word, Excel, PowerPoint.

Responsibilities

• Provide quality engineering support and direction in QA, control and preventative activities.
• Oversee NC & CAPA; mentor in problem solving and root cause analysis.
• Lead development/improvement of manufacturing processes for existing and new products.
• Review concessions and change management activities.
• Maintain KPI monitoring of process quality; analyze trends and take action.

Skills

Quality Assurance

CAPA

Problem Solving

Risk Management

Statistics

ISO 13485 Knowledge

Lean Six Sigma

Communication

Microsoft Office

Education

Bachelors in Science/Engineering

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Gage R&R

Job description

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.

Job Description

• 23-month fixed term contract**

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

#IJ

Ireland Pay Ranges

• Ireland: €47,000 - €77,000 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.