14 Quality Engineer Jobs in Plano, TX
Spark Life Solutions Inc is Hiring a Quality Engineer Near Plano, TX
Responsible for quality oversight of the design, development, and production of medical device and combination products with focus on risk mitigation, phase appropriate design reviews, continuous improvement, and qualification strategy implementation.
Job Title: Quality Engineer
Location: Texas
Roles & Responsibilities:
- Represent the quality function in product development projects providing support for development and commercialization activities. Author design history file documents during the development process.
- Translate user input into measurable product requirements and specifications.
- Support design verification and validation activities, including authoring test protocols and reports
- Ensure compliant project documentation providing clear status and traceability in alignment with good documentation practices and controls hierarchy.
- Manage, trend, and continuously improve assigned quality system element (CAPA, Complaints, Supplier Management, External Audits, etc.).
- Participate in risk analysis assessments of medical devices.
- Maintain accurate and complete Design History Files, including regulatory submission documents.
- Assist with manufacturing transfer, including preparation and execution of process validation (IQ/OQ/PQ) protocols, and development of production inspection plans.
- Investigate, disposition, and resolve nonconforming material events during product development, pre-production, and production phases.
- Author new or revised procedures, train team members and release quality system procedures, as required.
- Support internal and external audits.
- Support supplier selection, qualification, and on-going monitoring.
- Facilitate investigations to determine root cause and failure modes.
- Maintain quality records, summarize data, and report quality metrics to the organization.
- Execute quality event initiation, investigation, and closure for nonconformance's, CAPA, change control and complaints. Perform effectiveness checks.
- Bachelor's degree in engineering, science, or relevant field
- 5 years in regulated manufacturing and/or development environment
- Proficiency with FDA 820 CFRs/ISO 13485/cGMP quality management system and requirements for medical devices and combination product development and manufacturing
- Experience using risk analysis and continuous improvement concepts
- Extensive experience with GxP requirements
- Strong technical written and verbal communication skills
- Experience leading and/or supporting audits.
Job Summary
Full Time
$96k-114k (estimate)
07/27/2024
09/25/2024
The job skills required for Quality Engineer include Verbal Communication, etc. Having related job skills and expertise will give you an advantage when applying to be a Quality Engineer. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality Engineer. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Quality Engineer positions, which can be used as a reference in future career path planning. As a Quality Engineer, it can be promoted into senior positions as a Quality Assurance Engineer III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Engineer. You can explore the career advancement for a Quality Engineer below and select your interested title to get hiring information.
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