Director, Quality

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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:

Johnson & Johnson is hiring for a Director, Quality to join our team located in Shockwave Medical Costa Rica.

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 d evelops 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 r esponsible 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