Quality Control Supervisor (2nd Shift) - Shockwave Medical
J&J Family of Companies
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
**Job Function:**
Quality
**Job Sub** **Function:**
Quality Control
**Job Category:**
People Leader
**All Job Posting Locations:**
Santa Clara, California, United States of America
**Job Description:**
Johnson & Johnson is hiring for a **Quality Control** **Supervisor (2nd Shift) – Shockwave Medica** l to join our team located in **Santa Clara, CA.**
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 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.
**An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.**
**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
_Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act._
_Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center_ _(ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource._
**The anticipated base pay range for this position is :**
$89,000 - $142,600
Additional Description for Pay Transparency:
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 Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits
Por favor confirme su dirección de correo electrónico: Send Email