Senior Quality Engineer - Orthopedics

About the role

DePuy Synthes, part of Johnson & Johnson's Orthopaedics business, is looking for a Senior Quality Engineer to be based at its Ringaskiddy site in Cork, Ireland. The role plans, conducts and directs engineering projects and studies, applies quality engineering tools and principles to improve products and processes, and supports quality and compliance across the product lifecycle.

Key responsibilities

• Support quality improvement initiatives such as process and product characterization, and review the effectiveness of PDCA, Six Sigma, Kaizen and Lean techniques
• Ensure products and processes comply with standards such as QSRs, ISO 13485, EN and the Medical Device Directive, including supporting internal and external audits
• Lead the Material Review Board, investigate non-conformances, CAPAs and customer complaints, and own quality metrics
• Approve IQ/OQ/PQ and software validation, and partner with supply chain and suppliers on process validation and control plans
• Develop control plans, measurement systems and sampling plans, and assess common versus special cause variation
• Review proposed process changes for risk and document risk mitigation techniques
• Create quality strategies for test method, process and design validation, communicate business issues to management, and follow HSE guidelines

Required profile

• Bachelor's degree, preferably in Engineering or a related technical field, with 4-6 years of related experience
• Experience in manufacturing/operations and in both FDA and European regulatory environments (preferred)
• Proven track record of implementing risk mitigation and demonstrated project management and leadership
• Understanding of the NPI process and process validation (preferred); GMP/ISO regulations (preferred)

Required skills

• In-depth knowledge of product and process risk management (FDA and ISO standards)
• Statistics, Lean and Six Sigma, including MSA, SPC and DOE
• Hands-on troubleshooting and problem solving; strong statistical software skills preferred

What we offer

• Base pay range of EUR 53,200 to EUR 84,295
• Annual bonus, vacation days, parental leave of at least 12 weeks, bereavement and caregiver leave, well-being reimbursement and insurance plans