Staff Engineer, Quality Assurance

About the role

Stryker is looking for a fully onsite Staff Quality Engineer in Carrigtwohill, Cork. The role provides quality leadership and direction in quality assurance, quality control and preventive activities across operations and other business functions, with a focus on prevention and continuous improvement of products and processes. It also involves leading quality initiatives and projects and working with internal customers on quality issues.

Key responsibilities

• Oversee and direct quality performance of products and processes with Operations and business functions, and resolve quality issues with internal and external teams
• Manage internal and supplier-driven non-conformances, including disposition through MRB, and coach others in CAPAs through root cause analysis
• Lead quality initiatives and projects locally and globally, and act as a recognised process owner in areas such as risk, concession and change management, lean, six sigma, validation, inspection and sampling
• Take part in or lead internal and external audits with regulatory representatives, and support validation strategies and manufacturing transfers
• Manage supplier relationships, monitor performance and coordinate communications on quality issues
• Interpret KPI trends, drive continuous improvement and contribute to local, global and corporate processes

Required profile

• Honours Bachelor's degree in Science or Engineering
• 4+ years' experience in a Quality or Regulatory Affairs role; prior industry experience desirable
• Good understanding of medical device manufacturing, ISO 13485 and GMP
• Fluent written and spoken English (B2 level)
• Willingness to work in a multi-site team and some travel (about 10%)

Required skills

• Lean Six Sigma training is a distinct advantage
• Proficiency in Microsoft Word, Excel and PowerPoint
• Knowledge of risk management, CAPA, audits, statistics, statistical sampling plans, process capability and gauge R&R
• Experience interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired

What we offer

• Pay range in Ireland of EUR 54,000 to 90,000 per year
• Possible incentive compensation such as bonus or commission
• Stryker's comprehensive benefits package