Quality Engineer – Design Assurance
Teleflex
full-time
Posted on:
Location Type: Office
Location: Kamunting • 🇲🇾 Malaysia
Visit company websiteJob Level
JuniorMid-Level
About the role
- Partner with R&D, Marketing, Regulatory Affairs, and Operations to support Value Engineering projects in product and process design
- Create and maintain risk files consisting of risk management plans, hazard and risk analyses
- Analyze post-market surveillance data periodically throughout a product’s lifecycle
- Support Clinical and Medical Writers in analyzing available clinical data
- Use appropriate quality tools and statistical techniques to collect and summarize data
- Ensure compliance with all practices related to the Quality Management System
- Interpret customer feedback to define user needs and product requirements
Requirements
- Degree or Diploma in Engineering, Science or Math
- Degree in Chemistry, Polymer Science, Statistics and Certificate in Quality Engineering
- Two to three years’ experience in related field
- Good technical writing ability including proficiency in Word, Excel, PowerPoint and QC tools
- Up to date knowledge on the validation requirements, ISO, standards, procedures
- Good knowledge in medical device requirements
- Excellent written and verbal communication skills
- Ability to articulate issues related to validation and manage multiple priorities with least supervision
Benefits
- Health insurance
- 401(k) matching
- Flexible work arrangements
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
risk managementhazard analysisstatistical techniquesdata analysistechnical writingquality toolscompliancevalidation requirementsISO standardsmedical device requirements
Soft skills
communication skillsability to manage multiple prioritiesarticulation of issuesteam collaboration
Certifications
Certificate in Quality Engineering