Senior Staff QE

Stryker; Ireland; On-site; EUR 62,000 - 105,000; Full time

Benefits offered by this job

Full benefits

Job summary

Stryker in Macroom, Ireland is seeking a Senior Staff Quality Engineer for a 23-month, fully onsite contract. The role drives quality leadership, preventive activities, CAPA and continuous improvement across operations and business functions.

You will mentor teams, manage audits, and ensure ISO13485, GDP and GMP compliance while collaborating with global QA and cross-functional partners. The position requires 6+ years in a regulated environment and a level 8 Bachelor’s degree, with a

Qualifications

• Honours Bachelor’s Degree – level 8.
• Masters or PhD advantageous.
• 6+ years’ experience in a regulated environment (e.g. Medical Device, Aviation, Aerospace, Automotive, Defence).
• Proficient understanding of Med Device manufacturing processes.
• Proficient in ISO 13485, GDP, and GMP with strong collaboration and attention to detail.

Responsibilities

• Provide quality leadership, direction and technical guidance in QA, QC and preventive activities.
• Lead initiatives to enhance quality performance and support internal customers on quality issues.
• Mentor teams and ensure compliance to regulations and standards.
• Collaborate with cross-functional teams to promote quality initiatives and manage supplier relationships.
• Lead CAPA problem solving, risk management and statistical analysis in production processes.
• Develop and maintain quality processes and validation strategies; oversee audits and reviews.
• Drive continuous improvement, KPI trend analysis and containment strategies on site.

Skills

Quality leadership

CAPA

Root cause analysis

Audit management

Risk management

Process improvement

Cross-functional collaboration

Education

Bachelor’s degree (level 8)

Masters/PhD advantageous

Tools

ISO 13485

GMP

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%