Senior Quality Engineering Manager - Medical Devices

About the role

A senior Quality Engineering manager is needed for a medical device facility in Costa Rica. The role manages the activities, resourcing and goals of the Quality Engineering team so that it can support product lines through verification and validation, pFMEAs, test method validation, process change risk analysis and product investigations. It also leads team building, cross-functional quality leadership and regulatory audit support.

Key responsibilities

• Manage the goals, resourcing and activities of each team, and plan and prioritize product, process and quality work in line with compliance standards
• Provide technical guidance to cross-functional teams on quality engineering, root cause analysis, complaints, corrective actions and product/process changes
• Ensure investigations such as OOT, CAPA, IACA and complaints are done on time, at the right risk level and drive to root cause solutions
• Implement quality tools such as control plans, design of experiments, CpK/PpK, APQP, sampling plans, ANOVA and Gage R&R
• Lead team building and engagement, recruit staff, develop job descriptions and Individual Development Plans, and coordinate budgets
• Support EHS programs, develop quality team leaders, and lead metrics reporting at all meeting levels
• Support internal and external audits from regulators and notified bodies, participate in containment and kaizen meetings, and support cost-reduction projects
• Maintain, improve and simplify procedures, processes and methods

Required profile

• Bachelor's degree in Engineering or a related field; a Master's in Administration, Project Management or similar is desirable
• More than 10 years of professional experience in a similar industry, including 2 years in management positions
• Experience in Quality Engineering and Quality Management, and proven interaction with Notified Bodies and regulators
• Experience in the medical device industry, including ISO 13485 knowledge
• Spanish and English at 90-100% (written and oral) are desirable

Required skills

• ISO 13485 and medical device Single Audit Program (MDDAP)
• Lean tools such as Six Sigma and Advanced Product Quality Planning
• Design of experiments, process capability studies, FMEA, SPC and statistical knowledge
• Intermediate Microsoft Office; Minitab, Visio, Project, Oracle and Agile are desirable