Great and growing client is looking for a Quality Engineer to work remotely for a 12 month contract. This candidate will assure product design history files meet the regulatory requirements of Medical Device Regulations (MDR 2017/745, internal quality system and other applicable regulations).
location: Cordova, Tennessee
job type: Contract
salary: $40 - 50 per hour
work hours: 9am to 5pm
- Work to update legacy product design history file to comply with EU MDR 2017/745 focusing on product design documents. This includes but is not limited to Product lists and product specifications.
- Ability to analyze post market data and update design inputs as required based on current design and data.
- Assess or perform, where necessary, design verification and validation to support acceptable design risk mitigation, which may include hazardous materials assessment, human factors analysis, and lifetime evaluations.
- Work with Research and Development to produce evidence that products meet the requirements of applicable ISO, ASTM, IEC specifications.
- Aid other groups to ensure that literature and labels reflect requirement of EU MDR
- Work with packaging team to ensure packaging material risk is mitigated and captured with Product specifications as required by internal procedures and requlations.
- Actively participate with cross functional teams to mitigate risk to acceptable level with adequate documentation. This includes but is not limited to Microbiology, Biocompatibility and Clinical.
- Ability to identify products included in project based on planning an project charters/product families.
- Apply knowledge of FDA's Guidance document for Design Control, 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 development engineer on one or more EU MDR project teams. Ensure that required documentation/evidence is available in coordination with activities, and interfacing with project team members including engineering, regulatory, marketing, change management, post market surveillance, microbiology, biocompatibility, Clinical Affairs and production.
- 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.
- Coordinate activities with Management and Project Management Office (PMO) and report regularly on the progress of activities.
qualifications: Required Qualifications
- Clear and concise written and verbal communication Ability to multi-tasks, prioritize, meets/exceed deadlines and hold themselves accountable
- Self- starter, with the ability to work independently
- Software programs - Microsoft Word, PowerPoint, Excel, Project.
- Experience with managing documents within electronic PLM system
- Corrective and Preventative action experience including root cause analysis
- Experience with working with cross functional teams.
Standards and Regulations
- EU MDR 2017/745
- EU MDD 93/42/EEC
- ISO 13485
- 21 CFR Part 820
- ISO 14971
- 21 CFR Part 820
- FDA's guidance document on Design Controls
Experience with Standards and Regulations
- Remoted working environment experience
- Experience with Matrix PLM system
- Experience with SAP
- ASQ certification as a Certified Quality Biomedical engineer
- Six-Sigma or equivalent green/blackbelt certification
- Power-BI-Data Visualization
- Bachelor's degree in engineering or equivalent scientific discipline
YEARS OF EXPERIENCE
- Preferred experience includes 4+ years at medical device company serving as a Product Development Engineer supporting design control teams with a BS degree. 2+ years experience creating product design specifications (i.e. drawings using Unigraphis/NX). Alternative considerations include 4+ years in product engineering experience in a GMP environment. 2+ years experience with a Master's degree
- Quality Engineer, Medical Device Regulations, Design Control, Product Development, Unigraphics/NX, GMP
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.