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Job Function:

Supply Chain Engineering:

Job Sub Function:

Quality Engineering

Job Category:

People Leader

All Job Posting Locations:

Alajuela, Costa Rica

Job Description:

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

Position Overview:

The Manager, Quality provides leadership for the Sustaining Quality Engineering and Complaint Investigation programs at Shockwave Medical. This role will be responsible for supporting both manufacturing operations and customer complaints. Works on problems and projects of moderate to complex scope where analysis of situation or data requires a review of identifiable factors. Participates in decisions on scope of work, risk management, length of tasks and compliance pathways. Develops and implements procedures and systems to assure Shockwave Medical complies with FDA, ISO 13485, and other applicable regulatory standards related to the medical device industry.

Essential Job Functions:

Directly responsible for ongoing management, execution and improvements to the following Quality System activities:

• Ensure compliance with the Quality Management System (QMS) at Shockwave Medical.

• Manage the Sustaining Quality Engineers and the Complaint Investigation Technicians within the Quality organization.

• Provide guidance and assist in prioritizing the workload between complaints and manufacturing support.

• Partner with Manufacturing and Operations teams to find solutions to technical problems.

• Collaborate with Manufacturing Engineering to improve manufacturing processes and overall product quality.

• Work with Sustaining Quality Engineers and Post Market Surveillance Team members to maintain and improve complaint closure rates.

• Provide Quality Assurance leadership and guidance during product launches, process validations, and continuous improvement activities in a cross-functional environment.

• Maintain audit readiness in all areas of responsibility.

• Work with Quality Engineers to develop an audit program for auditing production lines and ensuring compliance to processes and procedures.

• Maintain and manage the Servicing Program and coordinate servicing activities with internal and external parties.

• Provide Quality Engineering support to the Manufacturing line and assist in maintaining validated processes.

• Support Finished Goods Distribution and Commercial operations Quality activities.

• Provide guidance to direct reports on non-conformances (NCRs).

• Lead/support the completion of Quality Plans.

• Drive assigned CAPAs to successful completion.

• Assist in maintaining compliance with other areas of the QMS as needed (Non Conformance, Complaints, Post Market Surveillance, Management Responsibility, Supplier Controls, Audit Support, etc.)

• Develop, establish and maintain user-friendly process documents.

• Other duties as needed

Requirements:

• Bachelor’s Degree in an engineering discipline
• Minimum of seven (7) years of experience in medical device industry
• Minimum of 2 years of experience in supervisory or management positions
• Excellent understanding of medical device regulations with strong quality knowledge and experience. Desire and ability to teach and convey standards and regulations to the organization
• Strong front room audit experience with an ability to effectively present and defend quality systems
• Strong analytical and problem-solving skills
• Excellent written and verbal communication and leadership skills
• Experience investigating customer complaints and writing up complaint investigations
• Strong background in statistics and statistical analysis
• 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
• Identifies and manages continuous improvement projects with the objective of achieving quality
• Responsible for coaching, training and development of subordinates
• Experience with software validation is preferred
• Must be willing work in a Class 100,000 (ISO Class 8) Cleanroom as necessary
• May be required to lift objects up to 25lbs
• May be required to travel 20% of the time (domestic and international)

Required Skills:

Preferred Skills:

Business Behavior, Coaching, Controls Compliance, Cross-Functional Collaboration, Developing Others, Engineering, Fact-Based Decision Making, Inclusive Leadership, Industry Analysis, ISO 9001, Leadership, Lean Supply Chain Management, Process Improvements, Quality Control (QC), Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Team Management