Senior Staff QE

Stryker Corporation; Hartnett's Cross; On-site; EUR 62,000 - 105,000; Full time

Benefits offered by this job

Full benefits

Job summary

Stryker Corporation in Macroom, Ireland, is seeking a Senior Staff Quality Engineer to lead quality assurance, control and preventive activities within operations. You will drive continuous improvement, mentor teams, and ensure compliance with ISO 13485 and GMP.

This onsite role requires strong collaboration, risk management, and the ability to address production-related issues and CAPA across multiple functions. 6+ years in a regulated environment are expected.

Qualifications

• Honours Bachelor’s Degree (level 8); Master’s/PhD advantageous.
• 6+ years’ experience in a regulated environment (e.g., Medical Device).
• Proficient understanding of Medical Device manufacturing processes.
• Proficient in ISO 13485, GDP, and GMP.
• Strong collaboration and communication skills across levels.

Responsibilities

• Provide quality leadership and guidance in QA/QC and preventive activities.
• Lead initiatives to enhance quality performance and CAPA within the business.
• Support internal customers on quality issues and audits and provide technical support for quality system assessments.
• Mentor quality teams and manage supplier relationships and internal/external nonconformities.
• Apply risk management, statistical analysis and process control methods in production.

Skills

Regulated environment experience

Medical device manufacturing

ISO 13485/GDP/GMP

Communication skills

Cross-functional collaboration

Education

Bachelor’s degree

Master’s or PhD advantageous

Job description

Work Flexibility: Onsite

This is a 23 month contract with full Stryker benefits. It is a fully onsite role in our Macroom siie.

What you will do:

The Senior Staff Quality Engineer will provide quality leadership, direction and technical guidance in quality assurance, quality control and preventive activities within operations and other business functions, with a focus on preventive measures and continuous improvement of products and processes. Lead and strategize initiatives & projects to enhance quality performance within the business. Work with internal customers in support of quality issues and provide technical support for activities related to quality system assessment and performance evaluation. Mentor and provide technical direction across multiple areas of expertise. Ensure compliance to regulation and standards. Work closely with business functions to ensure best-in-class performance of products and processes, as well as collaborate in cross-functional teams to address urgent quality issues. Collaborates with Corporate, global, Divisional QA and cross-functional teams to promote quality initiatives. Understand and apply external Standards to quality processes Support in the processing and analysis of production-related complaints as well as in market promotions. Lead expert in problem solving and root cause analysis within CAPA. Participation in the development and continuous improvement of quality processes, as well as manufacturing processes of existing and new products. Establishing KPI trends, taking action and promoting a continuous improvement process. Application of risk management procedures and concepts in the production process. Participation in the development and maintenance of methods of peer review and sample testing. Application of statistical analysis/ process control methods to manufacturing processes. Implement human error prevention practices and competently identify and mitigate the influence of human factors. Aids in the development of validation strategies, certified in multiple disciplines of validation to approval level. Developing strategies for optimising production transfers to other plants/facilities as well as management of quality measures. Lead and facilitate in internal and external audits Control/representation in audit management. Manage supplier relationships, including but not limited to, coordinating communications, monitoring performance, managing in house and external nonconformities and ensuring timely delivery of quality materials and services. Mentoring for the quality team and other corporate functions on quality issues and activities; Ownership of quality processes across locations. Site Quality representative in review boards, business review meetings as needed Lead/manage quality initiatives/projects locally and participate in global initiatives. Understand and lead to the containment strategy on site level, Decision on the use of non-compliant products. Responsible for initiation, management and support of ship, product Holds, potential product escapes.

What you will need:

Honours Bachelor’s Degree – level 8 Masters / PhD advantageous 6+ years’ experience in a regulated environment required, e.g. Medical Device, Aviation, Aerospace, Automative, Defence). Proficient understanding of Med Device manufacturing processes required. Proficient in ISO 13485, GDP, and GMP. Outstanding collaboration and communication skills with high attention to detail. Able to communicate up/down and across different levels of the organization, and build strong relationships internally and externally.

Ireland Pay Ranges:

Ireland: €62,000 - €105,000 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. If you’d like to learn more about the salary or the benefits associated with this role, your recruiter will be happy to walk you through the details as you progress through the hiring process.

Travel Percentage: 10% Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com

• Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location.
• Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based.
• Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category.
• Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.