Quality Engineer

Responsibilities

  • Assure product design history files meet the regulatory requirements of FDA Medical Device Regulation, internal quality system and other applicable regulations.

  • Apply knowledge of ISO 14971 Risk Management; IEC 60601-1 Medical Electrical Equipment and collateral standards, IEC 62366 Usability, and IEC 62304 Software Lifecycle; and other applicable standards to sustaining engineering projects.

  • Serve as primary quality representative. Ensure risk management documentation is updated in coordination with activities, and interfacing with project team members including engineering, regulatory, marketing, management, post market surveillance, and production.

  • Produce technical reports to support product changes or quality assurance investigations.

  • Prepare, evaluate and critique technical documentation including design justifications and rationales based on sound scientific or engineering principles.

  • Makes decisions and proposes solutions based on calculated risks identified through data analysis.

  • Evaluate procedures and processes within the quality system to identify areas for improvement. Recommend solutions to identified problems.

  • Report regularly on the progress of activities.

  • Participate in meeting company goals and objectives; on time project delivery per release project schedule

  • Travel requirement: Occasional domestic travel may be required less than 10%

 

Qualifications

  • Bachelor’s or Master’s degree in engineering or related discipline

  • 1-3 years of experience in medical device or related industry 

  • Clear and concise written/electronic and verbal communication.

  • Ability to multitask, prioritize, meet/exceed deadlines and hold themselves accountable.

  • Self-starter, with the ability to work independently

  • Software programs - Microsoft Word, PowerPoint, Excel, G-Suite, Jira

  • Experience with managing documents within electronic QMS 

  • Corrective and Preventive action experience including root cause analysis

  • Experience with working with cross functional teams

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Preferred list of skills​

  • ASQ certification as a Certified Quality Engineer or Biomedical engineer

  • Six-Sigma or equivalent greenbelt certification

 

Standards and Regulations Required

EU MDR 2017/745

EU MDD 93/42/EEC

ISO 13485

21 CFR Part 820

ISO 14971

ISO/IEC 81001-1 

IEC 60601-4-5 

IEC 80001-5-1

IEC 62366

IEC 62304

 

Job Type: Full-time

Benefits: 401(k), 401(k) matching, Employee discount, Flexible schedule, Flexible spending account, Health insurance, Paid time off
Ability to Commute/Relocate: Houston, TX (Required)

Work Remotely: No

 

Contactmwang@instapathbio.com