Staff Engineer, Quality Assurance

Strykerdata; Cork; Hybrid; EUR 54,000 - 90,000; Full time

Benefits offered by this job

Comprehensive benefits

Bonus incentive eligibility

Job summary

Stryker is seeking a Staff Quality Engineer to lead quality assurance, quality control and preventive activities onsite in Carrigtwohill, Ireland. You will champion quality systems, support regulatory compliance, and drive continuous improvement across product and process quality.

The role requires strong leadership, problem solving, and cross-functional collaboration to resolve quality issues with Operations and suppliers. Travel to multi-site locations may be involved as part of this role.

Qualifications

• Honours Bachelor’s Degree in Science/Engineering or related
• 4+ years’ experience in a Quality or Regulatory Affairs role; prior industry experiences desirable
• Proficient in understanding of Med Device manufacturing processes, ISO 13485, GMP
• Lean Six Sigma training is a distinct advantage
• Outstanding communication and attention to detail; able to communicate across levels
• Knowledge of Risk Based and statistical techniques (CAPA, Audits, Statistics)

Responsibilities

• Lead quality leadership and preventive activities across operations and business functions
• Drive continuous improvement of products and processes
• Coach and provide technical direction across multiple areas of expertise
• Manage internal and supplier-driven Non-Conformances (NCs) and CAPAs
• Dispostion of non-conforming product through MRB and NC issuance
• Lead and participate in internal/external audits with regulatory reps
• Input into concession/change management and risk assessment processes
• Develop validation strategies and support manufacturing transfers
• Monitor KPI trends and drive corrective action and improvement
• Travel as required to support multi-site activities

Skills

Strong communication

Leadership & mentoring

Problem solving

Cross-functional collaboration

Risk management

Education

Bachelor’s Degree in Science/Engineering

4+ years in Quality or Regulatory Affairs

ISO 13485, GMP knowledge

Lean Six Sigma training

Regulatory audits experience (FDA/MoH/TUV)

MS Office proficiency

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Fully onsite in Carrigtwohill

The Staff Quality Engineer will provide quality leadership and direction 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.

Advocate and lead the execution of initiatives & projects to enhance quality performance within the business. Work with internal customers in support of quality issues, provide technical support for activities related to quality system assessment and performance evaluation. Coach and provide technical direction across multiple areas of expertise. Ensure compliance with regulations and standards.

Essential Duties & Responsibilities

• Work closely with Operations and business functions providing oversight and direction on quality performance of product and processes
• Collaborate cross-functionally with internal and external teams to resolve quality issues
• Manages internal and supplier-driven Non-Conformances (NCs), ensuring timely investigation and closure
• Owns and coaches others in Corrective and Preventive Actions (CAPAs) through root cause analysis to closure
• Disposition of non-conforming product through MRB, issuing NCs as appropriate
• Coach the quality team and others business functions in quality topics and activities.
• Leads the execution of quality initiatives / projects at local & global level.
• Recognized process owner in areas of expertise. Expertise across multiple areas from the following, problem solving, risk, concession & change management, lean, six sigma, CAPA, statistics, validation, inspection processes & sampling etc.
• Input into local, global & corporate processes, a representative on review & discussion boards and teams for expert & valued input.
• Provides input / assessment and justification during concession / change management and quality issues. Review and approval of same driving strong review.
• Interpret KPI trends, take action as necessary, driving a continuous improvement process.
• Understanding of Human Error Prevention and the application of those principles to the manufacturing environment.
• 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 provides technical direction in optimization of inspection methods and sampling
• Participate in and may lead internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise and overview of the business. Oversight / deputies for audit management, logistics and preparation as required.
• Aids in the development of validation strategies, certified in disciplines of validation to approval level.
• Support/ Leads manufacturing transfers to other plants/facilities
• Responsible for initiation, management and support of ship, product Holds, potential product escapes.
• Provide/ support facilitate during internal and external audits
• 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.

Education / Qualifications & Experience

• Honours Bachelor’s Degree - Science/Engineering
• 4+ years’ experience in a Quality or Regulatory Affairs role; prior industry experiences desirable
• Proficient in understanding of Med Device manufacturing processes, ISO 13485, GMP.
• Lean Six Sigma training is a distinct advantage.
• Outstanding communication skills and attention to detail. Able to communicate up/down and across different levels of the organization.
• Detailed understanding of engineering and quality principles, including Risk Management, CAPA, Audits, and Statistics
• High level knowledge/experience of Risk Based and statistical techniques, in particular process risk, statistical sampling plans, Process Capability, Gauge R&Rs.
• High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired.
• Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).
• Exhibits strong leadership and mentoring behaviors. Provides coaching and guidance to others to ensure compliance to technical, regulatory and Stryker requirements.
• Highly developed in problem-solving, analytical, and communication skills with high attention to detail
• Highly motivated and builds strong relationships through open communication, respect, and trust
• Critical thinking and strong analytical skills Demonstrated ability for conflict resolution and constructive competence.
• Strong team player and acts with a customer service/stakeholder focused approach Is diplomatic, tactful and leverages excellent interpersonal keys to help achieve outcomes.
• Diplomatic, tactful, and effective at leveraging interpersonal skills
• Embraces change with a continuous improvement mindset.
• Fluent in written and oral English - B2 Level (writing documents, meeting minutes, conference calls, technical writing, presenting etc.)
• Confident representing Quality in cross-functional settings
• Self-starter able to manage multiple tasks in a fast-paced environment
• Willing to work as part of a multi-site team; some travel required

#IJ

Ireland Pay Ranges

• Ireland: €54,000 - €90,000 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.