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Job Function:

Quality

Job Sub Function:

Multi-Family Quality

Job Category:

People Leader

All Job Posting Locations:

Alajuela, Costa Rica, Santa Clara, California, United States of America

Job Description:

Position Overview:

The Director of Quality is responsible for the administration, supervision, and development of the Quality group in Costa Rica. They are expected to provide leadership for the organization’s quality engineering, quality control, quality systems and document control, calibrations, and risk management program. The Director of Quality develops and implements procedures and systems to assure Shockwave Medical, Costa Rica complies with applicable regulatory standards such as:

• ISO 13485 – Medical Devices – Quality Management Systems
• 21 CFR 820 and 21 CFR 803
• ISO 14971 Application of Risk to Medical Devices
• Council of the European Communities Directive 93/42/EEC - Medical Device Directive
• Current Good Manufacturing Practices (CGMP) Quality Systems Regulation
• EU MDR – European Medical Device Regulation (MDR)
• MDSAP and other relevant geography regulations
• CMDR - Canadian Medical Devices Regulations

Essential Job Functions

Site Establishment

• Is directly responsible for the implementation of a Quality Management System for the Shockwave CR site and document control functions for the Shockwave CR site
• Interfaces with Santa Clara (headquarters) personnel to ensure continued compliance to overall corporate and Costa Rica site specific requirements
• Coordinates with the Shockwave-Santa Clara site to support the transfer and validation of manufacturing lines at the Shockwave-CR site

Compliance

• Acts as the Quality Representative, and host, for external Quality audits (eg: FDA, BSI, JJRC)
• Plans and executions for Management Reviews for the Shockwave CR site
• Ensures that product and process changes are approved by Santa Clara personnel prior to implementation at the Shockwave CR site
• Manages, executes, and makes improvements to the following quality system activities: CAPA, Complaints and NCRs, Internal Audit Program, Supplier Audits

Operations

• Supervises Manages, Document Control, Quality Engineers, Quality Compliance Specialists, QC Supervisor, and provides general oversight of the entire QC Technician Team
• Leads the Document Control functions and related responsibilities, including, but not limited to, Lot History Record review and standards management
• Is responsible for ongoing management and improvements of the QC testing lab
• Applies statistical and engineering techniques to determine sampling parameter testing requirements
• Oversees equipment calibration program
• Supports equipment installation qualification and preventative maintenance program
• Oversees incoming, in-process and final product inspection and final product release to distribution activities
• Establishes employee training and development, and maintains and supports improvements to employee training in QSR and ISO regulations
• Provides coaching and training to direct reports
• Interfaces with R&D, RA, and Operations to interpret Engineering requirements, and to draft, review and approve specifications for products, processes and components
• Maintains process controls per approved design control files, and ensures they are effectively implemented
• Is responsible for managing quality engineering resources for New Products
• Directs or provides input, including statistics, to Process Validations and
• Verification activities and planning

Other

• Stays current with regulatory changes through industry publications, seminars, participation in trade organizations, and government meetings
• Works cross-functionally and has the ability to interpret the regulatory and engineering requirements as well as educate and influence others on those requirements
• Demonstrates ability to perform investigations, root cause analysis and develop corrective actions
• Identifies and manages continuous improvement projects with the objective of achieving high standards of quality
• Other duties as assigned

 

Requirements:

• Bachelor’s Degree in Engineering, with 15+ years of relevant engineering experience or a Master’s Degree in Engineering with 12+ years of relevant engineering experience
• 5+ years of managerial experience
• Excellent understanding of medical device regulations, medical device quality management systems, supervisory or project management skills and strong quality knowledge and experience
• Certified Quality Auditor is a plus, but not required
• Ability to travel internationally between Coyol (Costa Rica) and Santa Clara (US) up to 40% of the time
• Strong analytical and problem-solving skills
• Ability to effectively manage and supervise teams
• Prior experience in product / manufacturing line transfers is a plus
• Excellent communication and leadership skills
• Proficient in English and Spanish
• Strong written and oral communication skills
• Ability to work in a fast-paced environment while managing multiple priorities
• Operate as a team and/or independently while demonstrating flexibility to changing requirements

 

 

Required Skills:

 

 

Preferred Skills:

Budget Management, Compliance Management, Corrective and Preventive Action (CAPA), Developing Others, Inclusive Leadership, Internal Auditing, ISO 9001, Leadership, Operations Management, Performance Measurement, Quality Control (QC), Quality Processes, Quality Standards, Quality Validation, Resource Planning, Risk Management, Standard Operating Procedure (SOP), Tactical Planning