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 compliance with standards such as QSRs, ISO 13485, EN and the Medical Device Directive, including supporting internal and external audits and conducting line audits
• Partner with R&D on design controls, risk management and design failures, and support new product introduction and design transfer
• Lead and maintain the Material Review Board, investigate non-conformances, CAPAs and customer complaints, and review root causes and quality metrics
• Approve IQ/OQ/PQ, TMV and software validation, and develop control plans, measurement systems and sampling plans
• Assess 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
• Ability to troubleshoot hands-on and make sound judgments

Required skills

• In-depth knowledge of product and process risk management (FDA and ISO standards)
• Statistics, Lean and Six Sigma, including MSA, SPC, DOEs and reliability
• Knowledge of GMP/ISO regulations and validation regulations (preferred)
• Understanding of NPI and process validation (preferred)
• Strong statistical software skills preferred

What we offer

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