Manager, Quality
Description
Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.
Description
This position provides leadership for the Sustaining Quality Engineering and Complaint Investigation programs at Shockwave Medical as required. 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 as applicable.
Provide guidance and assist in prioritizing the workload between complaints and manufacturing support as applicable.
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 with 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 with 7 years’ experience in Medical Device Quality, Manufacturing, or Engineering
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 10% of the time (domestic and international)
Benefits
Shockwave Medical offers competitive total compensation packages in line with market requirements.