Quality Control Supervisor
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
- Supervise Quality Assurance activities required to support operations at SWMI.
- Mentor and support Quality Technicians
- Provide Quality Assurance leadership/guidance during investigation of issues pertaining to products and processes and will support the product launch, process validation, and continuous improvement activities in a cross-functional environment.
- Develop and initiate standards and methods for inspection, testing and evaluation.
- Assist in preparation of detailed inspection planning and instruction sheets.
- Coordinate with Quality Engineering and product engineers to determine inspection and testing needs.
- Train new technicians on processes and procedures on the use of specific gauges and measuring equipment, sampling, attribute and variable data recording, and records review.
- Generate detailed and accurate inspection and testing reports according to Current Good Manufacturing Practices (cGMP), and maintain inspection and testing files.
- Provide quality assurance leadership/guidance on projects while staying in compliance with FDA, ISO, EU, and other applicable medical device regulations as well as SWMI Quality System requirements.
- Lead/guide teams in conducting investigations related to non-conformances and/or customer complaints. Identify opportunities for process improvements.
- Implement improvements to inspection and test documentation, and quality system processes. Execute activities needed to support change control and documentation management processes.
- Lead/guide teams in preparing for internal and external audits and provide support for the execution of those audits. Assist with on-site or remote supplier audits as needed.
- Maintain QA related logs and databases (e.g. IQC, Equipment).
- Perform review of calibration certificates and support administration of the calibration system as needed.
- Perform QA related data entry and generate reports as required.
- Execute written protocols, gather data, and generate reports.
- Assist in identifying continuous improvement opportunities.
- Audit production lines to ensure QSR/GMP compliance as assigned.
- Maintain audit readiness of the Incoming Inspection, RMA and Calibration System and other areas of the QMS as assigned.
- Perform Sterile Load processing review, Device History Records review, and product release activities as assigned.
- Perform other QA related activities as assigned.
- Other duties as assigned.
Requirements
- 2+ years of supervisory experience in the Quality function in the medical device industry
- Associate’s degree or equivalent industry experience
- Minimum of 7 years of experience performing Quality inspections/testing activities pertaining to IQC, in-process, lot release and V&V, and administration of various Quality Management Systems in the medical device industry
- Experience working in a Cleanroom environment
- Certified Quality Technician (CQT) or Certified Quality Improvement Associate (CQIA) preferred
- The ability to understand and follow Quality Management System Procedures (e.g., SOP and Test Methods)
- Strong understanding of, cGMP, QSR and ISO13485 requirements
- Working knowledge in reading and interpreting technical specifications and mechanical drawings
- Strong knowledge of a wide variety of inspection and test equipment, and methodologies
- Excellent visual acuity to perform activities such as: preparing and analyzing data and figures; transcribing data; visual inspection using a microscope involving small defects and small parts; using measurement devices; and assembly of parts at close distances
- Experience with computer-based applications (MS Word, MS Excel, ERP)
- Excellent written and verbal communication skills
- Strong time management skills and the ability to multi-task in a fast-paced environment
- Excellent organizational 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
- Employee may be required to lift objects up to 25lbs
Market Range: $83,000 - $104,000
Exact compensation may vary based on skills, experience, and location.
Benefits
Shockwave Medical offers a competitive total compensation package as well as the following benefits and perks:
Core Benefits: Medical, Dental, Vision, Pre-tax and Roth 401k options with a fully vested match, Short-Term and Long-Term Disability, and Life Insurance, Employer contribution toward Health Savings Account (HSA), Competitive PTO balance
Perks: ESPP, Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards
EEO Employer