Johnson & Johnson MedTech · 23 hours ago
Sr. Quality Engineer- Shockwave Medical
Santa Clara, CA
Full-time
Onsite
Mid, Senior Level
$91K/yr - $147K/yr
5+ years expJohnson & Johnson is a leader in healthcare innovation, committed to delivering breakthroughs that impact health for humanity. The Sr. Quality Engineer will support manufacturing and work cross-functionally to resolve technical problems, ensuring compliance with quality standards and participating in the development of new medical device treatments.
Hospital & Health Care
Responsibilities
Responsible for developing, applying, revising and maintaining quality standards for processing materials/products into partially or finished products
Designs and implements methods and/or procedures for inspecting, testing and evaluating the precision and accuracy of products, components, sub-assemblies and/or production equipment
Analyzes nonconformance reports and returned products and recommends corrective action
Prepares documentation for inspection/testing procedures, development studies, validation protocols and reports, quality plans, product defect investigations and inspection plans. Must be able to write a technical document with sufficient clarity, detail and correctness to be submitted for regulatory review with confidence. Must be able to review and provide value-added feedback to others writing such documents
Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments
Plans and conducts work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria. Provides guidance to manufacturing and development engineers regarding documentation, process controls, data feedback systems, and best quality practices
Independently performs most assignments with an understanding of the overall expectations. Receives technical guidance on unusual or complex problems and supervisory approval on proposed plans for projects
Plans, schedules, conducts, and coordinates detailed phases of engineering work in part of a major project
Performs work which involves conventional engineering practice but may include a variety of complex features such as conflicting design requirements, unsuitability of conventional materials, and difficult coordination requirements
Work requires a broad knowledge of precedents in the specialty area and a good knowledge of principles and practices of related specialties. Familiarity with FDA guidance documents and ISO and ASTM standards related to quality and medical device industry is an asset
Independently assesses if components, sub-assemblies, products meet specification and can initiate, investigate and resolve non-conformances by working in conjunction with a multi-disciplinary team
Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance
Responsible for participating in design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes, and ensure the process has adequate and appropriate process controls. Responsible for participating and/or taking lead role in developing the risk management plan for new projects transitioning into manufacturing. (Hazard assessment, design trace matrix development, DV&V testing, and FMEA)
May technically supervise or coordinate the work of engineers, technicians, and others who assist in specific assignments
Practices company safety, quality policies and procedures, and actively requires conformance
May conduct internal and supplier audits. Certified as a lead auditor in ISO13485:2016 would be an asset. Familiarity with IEC 60601 and IEC 62304 is an asset
Processing, investigating, and completing customer complaints, which could require direct email responses to customers
Composes technical complaint reports timely and accurately based on reported information and device investigation data
Responsible for developing and maintaining calibration requirements for tools and equipment in the R&D, Manufacturing, and Quality areas
Knowledge of statistics and Minitab, including process capability and data normality assessments, analysis of variance, hypothesis testing, determining appropriate sample sizes, tolerance interval assessments for variable and attribute data, design of experiment (DOE), and variable and attribute sampling plan applications would be a great asset
Other duties as assigned
Qualification
Required
BS in a related engineering discipline and 5+ years of related experience; or MS in a related engineering discipline and 3+ years of related experience
Strong technical writing skills are required
Experience in customer complaint investigations and complaint report writing
Experience in manufacturing support as a Quality Engineer
Must be proactive, self-motivated, and work independently with minimal supervision
Must be willing to travel up to 10% of the time
Effective communication skills with all levels of management and organizations
Operate independently and adaptability to changing requirements
Ability to work in a fast-paced environment, managing multiple priorities
Preferred
Experience in the medical device industry is highly preferred
Experience with balloon catheters, automated machines and electrical systems with software validation is strongly preferred
Experience with Extrusion and Braiding is a plus
Experience in completing Medical Device Reports (MDR) and Vigilance (MDV) submissions is an asset
Experience in writing and reviewing design verification and validation protocols
Preferred experience in generating documentation and criteria for validation of manufacturing line transfer to alternative sites
Certification and/or license in a specific discipline would be an asset
Certified Quality Engineer would be an asset
Familiarity with FDA guidance documents and ISO and ASTM standards related to quality and medical device industry is an asset
Knowledge of statistics and Minitab, including process capability and data normality assessments, analysis of variance, hypothesis testing, determining appropriate sample sizes, tolerance interval assessments for variable and attribute data, design of experiment (DOE), and variable and attribute sampling plan applications would be a great asset
Analytical Reasoning
Coaching
Customer Centricity
Data Savvy
Document Management
Financial Competence
Good Automated Manufacturing Practice (GAMP)
Lean Supply Chain Management
Process Improvements
Quality Control (QC)
Quality Services
Quality Standards
Quality Systems Documentation
Quality Validation
Science, Technology, Engineering, and Math (STEM) Application
Supervision
Supply Planning
Technologically Savvy
Benefits
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
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 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
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Company
Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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