J&J Family of Companies
Quality Complaints Technician II
J&J Family of Companies, Santa Clara, California, United States, 95050
Quality Complaints Technician 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. Position Overview The Quality Complaints Technician II role will help maintain the complaint decontamination lab and support the cleaning and decontamination of returned products from the field. This includes returned complaint devices, customer returns, products returned from consignment, and trunk stock. Cleaning and decontamination procedures will be followed to ensure that returned items are handled safely and properly cleaned and/or decontaminated. The Quality Complaints Technician II directly supports Quality goals and metrics by coordinating the receipt and decontamination of complaint devices in a timely manner and may be required to assist with post decontamination responsibilities. Essential Job Functions Confirm returned product against the Return Material Authorization record. Work with the Receiving Dept to confirm or correct any discrepancies related to the returned product. Decontaminate returned devices from the field according to Quality and Safety procedures. Coordinate activities with Quality Engineers, Complaint Specialists, and Quality Management to determine priorities. Perform data entry into Complaint Management Systems and/or applicable logs as needed to comply with company policies and procedures. Send out daily status reports on units that have been completed. Perform investigation of complaint devices in collaboration with Quality Engineers as needed. Complete a detailed complaint device investigation write-up as needed. Attend weekly complaint meetings as needed to review complaint metrics and provide status updates on open complaints. Attend training on new products to support decontamination and investigation responsibilities. Understand common medical device inspection techniques and methodologies. Support company goals and objectives, policies and procedures, QSR, and FDA regulations. Interface and communicate effectively with cross-functional team members. Perform a review of the device FMEAs as required for the complaint investigation. Communicate and coordinate with Facilities, IT, and other departments to address any issues related to the decontamination lab. Other duties as assigned. Requirements High school diploma with a minimum of 2 years of experience in Quality Assurance or equivalent experience. Experience performing product cleaning and decontamination of medical devices preferred. Must be willing to work with biohazard materials while wearing proper protective equipment. Must be willing to work in a lab environment and follow proper safety procedures and protocols. Ability to understand and follow Quality Management System Procedures (e.g., SOPs and Work Instructions). Understanding of cGMP, QSR and ISO13485 requirements preferred. Experience with computer-based applications (MS Suite). Proficient written and verbal communication skills. Ability to work in a fast-paced environment while managing multiple priorities. May be required to lift objects up to 25lbs. The anticipated base pay range for this position is: $47,150 - $75,383. 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.
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. Position Overview The Quality Complaints Technician II role will help maintain the complaint decontamination lab and support the cleaning and decontamination of returned products from the field. This includes returned complaint devices, customer returns, products returned from consignment, and trunk stock. Cleaning and decontamination procedures will be followed to ensure that returned items are handled safely and properly cleaned and/or decontaminated. The Quality Complaints Technician II directly supports Quality goals and metrics by coordinating the receipt and decontamination of complaint devices in a timely manner and may be required to assist with post decontamination responsibilities. Essential Job Functions Confirm returned product against the Return Material Authorization record. Work with the Receiving Dept to confirm or correct any discrepancies related to the returned product. Decontaminate returned devices from the field according to Quality and Safety procedures. Coordinate activities with Quality Engineers, Complaint Specialists, and Quality Management to determine priorities. Perform data entry into Complaint Management Systems and/or applicable logs as needed to comply with company policies and procedures. Send out daily status reports on units that have been completed. Perform investigation of complaint devices in collaboration with Quality Engineers as needed. Complete a detailed complaint device investigation write-up as needed. Attend weekly complaint meetings as needed to review complaint metrics and provide status updates on open complaints. Attend training on new products to support decontamination and investigation responsibilities. Understand common medical device inspection techniques and methodologies. Support company goals and objectives, policies and procedures, QSR, and FDA regulations. Interface and communicate effectively with cross-functional team members. Perform a review of the device FMEAs as required for the complaint investigation. Communicate and coordinate with Facilities, IT, and other departments to address any issues related to the decontamination lab. Other duties as assigned. Requirements High school diploma with a minimum of 2 years of experience in Quality Assurance or equivalent experience. Experience performing product cleaning and decontamination of medical devices preferred. Must be willing to work with biohazard materials while wearing proper protective equipment. Must be willing to work in a lab environment and follow proper safety procedures and protocols. Ability to understand and follow Quality Management System Procedures (e.g., SOPs and Work Instructions). Understanding of cGMP, QSR and ISO13485 requirements preferred. Experience with computer-based applications (MS Suite). Proficient written and verbal communication skills. Ability to work in a fast-paced environment while managing multiple priorities. May be required to lift objects up to 25lbs. The anticipated base pay range for this position is: $47,150 - $75,383. 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.