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
Position Overview
The Quality Control Supervisor will work on second shift. The Quality Control Supervisor plans and directs activities and personnel responsible for performing inspections/testing activities pertaining to Incoming Quality Assurance, In-process Subassemblies and Finished Goods, and Lot Release Testing. This role is required to work cross-functionally to resolve Production issues and provide QC support on cross-functional projects.
Essential Job Functions
- 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