Sep 01, 2021

Quality Engineer Manager

$65,000 - $85,000 yearly
  • CenterMed
Full time Engineering Management Quality

Job Description

CenterMed, Inc. is a medical device startup focusing on developing patient-matched maxillofacial surgical plans and accessories. We are looking for a Quality Engineer to join our CenterMed team!

In this role, you will be working with other department partners to deliver safe and effective medical device designs for manufacturing, compliant with CenterMed policies and procedures. You will provide quality assurance support to company functions with a focus on process improvements and compliance to design controls in accordance with ISO13485, ISO 14971, 21 CFR Part 820.

Job Responsibilities:

  • Have a proven track record as a lead engineer and/or hands-on management
  • Mentor, develop, and empower your team by providing them with the knowledge, confidence, and drive to make independent decisions that will lead to their personal and professional success, as well as the ability to become technical leaders.
  • Create metrics to track success and report both internally and externally
  • Monitor manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained
  • Executes CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis
  • Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality
  • Maintains risk analyses
  • Works in individual and team settings. Works collaboratively with other departments to provide detailed data, analysis results and decisions
  • Applies standard practices and techniques in specific situations, adjusts and correlates data
  • Analyzes and reviews data to evaluate current production standards and identify trends requiring investigation
  • Recognizes discrepancies in results and follows operations through a series of related detailed steps or processes

Job Qualifications:

Support the development and maintenance of the total QMS documentation for the

company to ensure compliance to standards, including ISO 13485, ISO 14971, FDA

21CFR820

  • Bachelors degree in engineering
  • Experience within the medical device or other highly regulated industries highly preferred
  • Knowledge of US and International laws and standards that apply to the medical device

industry including FDA Quality Systems Regulations and ISO 13485

  • Ability to set and deliver to specific goals and targets
  • Ability to perform multiple tasks and prioritize engineering decisions
  • Effective analytical, technical, and problem-solving skills
  • Ability to work in or direct teams to acquire results

The Successful Candidate Will

  • Manage a heavy workload while maintaining accuracy
  • Identify potential roadblocks and provide innovative solutions
  • Operate with a high level of integrity and professionalism
  • Committed to and accountable for achieving goals and objectives 

Apply Now