Sr. Quality Engineer - Catheter Manufacturing
Company: Lawinger Consulting Inc.
Location: Santa Clara
Posted on: November 19, 2021
Sr. Quality Engineer - Catheter Manufacturing Sr. Quality
Engineer - Catheter Manufacturing
Santa Clara, CA 95054
Fulltime - Direct Hire Position Overview: Our client is seeking a
direct-hire Sr. Quality Engineer in the bay area to support
catheter manufacturing and work cross-functionally to resolve
technical problems. Participates in decisions on scope of work,
risk management, design changes, process improvements, material
disposition, and implementation of revised specifications. Provides
and develops solutions to broad problems, accomplishes complex
assignments, develops protocols for design, and/or process
activities, (including those related to verification or validation
activities), determines criteria and subsequently generates summary
(or final) reports. Essential Job Functions:
--- Responsible for developing, applying, revising, and maintaining
quality standards for processing materials and sub-assemblies 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
--- 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
--- 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
--- 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
--- Independently assesses if components, sub-assemblies, products
meet specification and can initiate, investigate and resolve
non-conformances by working in conjunction with a multi-
--- 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).
--- 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.
--- May technically supervise or coordinate the work of engineers,
technicians, and others who assist in specific assignments.
--- Other duties as assigned. Requirements:
--- 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
--- Experience in the medical device industry is strongly
--- Strong technical writing skills are required
--- Experience in customer complaint investigations and complaint
--- Experience in manufacturing support as a Quality Engineer
--- Must be proactive, self-motivated, and work independently with
--- Experience with balloon catheters and electrical systems is
--- Experience in completing Medical Device Reports (MDR) and
Vigilance (MDV) submissions is an asset.
--- Experience in writing and reviewing design verification and
--- Preferred experience in generating documentation and criteria
for validation of manufacturing line transfer to alternative
--- 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
--- Certification and/or license in a specific discipline would be
--- Certified Quality Engineer would be an asset
--- Must be willing to travel up to 10% of the time
--- Effective communication skills with all levels of management
--- Operate independently and adaptability to changing
--- Ability to work in a fast-paced environment, managing multiple
Keywords: Lawinger Consulting Inc., Santa Clara , Sr. Quality Engineer - Catheter Manufacturing, Engineering , Santa Clara, California
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