Document Control Specialist II - Shockwave Medical

Document Control Specialist II Shockwave Medical

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio 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.

In compliance with FDA, European MDD / MDR & ISO regulations, the Document Control Specialist II will perform work exercising judgment with only general supervision. General scope of this position is to maintain product related documentation and the flow of information in the form of controlled documents and engineering change orders, over the life cycle of any given product manufactured at SWMI. This position requires frequent use and general knowledge of industry practices, techniques, and standards.

Essential Job Functions :

• Maintain the change control process via engineering change control system (log, track and process changes, maintain material item data, and BOM data)
• Check revised documents and completed change orders to assure the highest level of accuracy and conformance with the approved format and standards
• Review, process, and release documents using variety of software packages.
• Maintain electronic files of master active or archived documents (native source application files as well as the .pdf viewable files)
• Maintain controlled access to master files and archived documents on Shockwave Medical's system and / or shared servers
• Assist in the data entry of employee training records when needed
• Assist maintenance of Direct Labor Competency Assessment Records when needed
• Support Regulatory Assurance by assisting backroom activities during audits
• May support periodic departmental audits to assure that the appropriate procedures are followed and that the highest levels of compliance are continually achieved
• Assist in implementation of solutions to a variety of problems
• Manage the review and approval of QMS changes.
• Other duties as assigned.

Requirements :

The anticipated base pay range for this position is : $56,350 - $89,930

Subject to the terms of their respective plans, employees and / or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs : medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits : Vacation 120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year Holiday pay, including Floating Holidays 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave 480 hours within one year of the birth / adoption / foster care of a child Condolence Leave 30 days for an immediate family member : 5 days for an extended family member Caregiver Leave 10 days Volunteer Leave 4 days Military Spouse Time-Off 80 hours