Sep 14, 2022

Quality Assurance Manager

$85,000 - $105,000 yearly
  • 3Oe Scientific
  • Remote (Indianapolis, IN, USA)
Full time Quality

Job Description

Job Summary

The Quality Assurance (QA) Manager is responsible for the daily execution of the Quality Management System (QMS). The Manager works closely with the CMSO, CTO, COO, Chief Legal Officer and Chief Success Officer to execute on quality objectives. Works closely with quality and regulatory consultants but remains a good steward of limited financial resources. Interfaces with Contract Manufacturer quality, manages/triages installer and customer feedback, executes supplier quality audits, and manages related quality engineers. Ensures that the leadership team remains informed and educated on quality and compliance concerns and responds to all concerns with independence and thorough action to assure the success of the company.

Responsibilities, Role and Function

The QA Manager is responsible for the following:

Daily execution of the QMS

  • Collaborate with internal and external Engineering teams to ensure QMS processes are followed throughout the product development lifecycle
  • Execute and maintain QMS processes aligned with ISO 13485:2016
  • Establish and ensure completion of quality objectives
  • Maintain and update Risk Management File (RMF)
  • Ensures QMS processes and procedures are updated, documents are filed, etc.
  • Ensures maintenance of the Design History File and Design Control Matrix
  • Execute periodic management reviews
  • Coordinate and manage internal and external audits
  • Execute and maintain supplier management program, including occasional travel to supplier sites to conduct audits independently (as required, estimated 3 days/quarter travel)
  • Execute and maintain company training program
  • Review and shepherd design and document changes through the Change Order (CO) process
  • Manage and maintain the Document Management system in Greenlight Guru
  • Support regulatory submissions, as required
  • Interface with and maintain quality culture with executive team
  • Create and maintain test reports to support testing efforts, as required

Production/Post-Production activities

  • Maintain and update RMF
  • Establish and manage CAPA processes
  • Evaluate and coordinate necessary actions from internal and external customer complaints and feedbacks in collaboration with 3Oe Scientific’s Customer Success team
  • Collaborate closely with production partners to ensure high quality product is produced
  • Collaborate closely with installation and service teams to ensure installation and service procedures are followed
  • Conduct root cause analyses in collaboration with Engineering
  • Evaluate and approve deviations and non-conformances in production

Qualifications

Education & Experience

  • Bachelor’s degree – preferably in engineering
  • Minimum of 5 years’ experience in Quality Assurance in the medical device or biotechnology industries
  • Background with ISO 13485 and 21 CFR Part 820 required
  • Project management experience preferred

Job Knowledge & Skills

  • General understanding of ISO 14971 – Risk Management for Medical Devices
  • General understanding of Good Manufacturing Practices
  • Experience with electro-mechanical, class II medical devices is preferred
  • Strong written and oral communication skills
  • Strong analytical and troubleshooting skills
  • Strong problem-solving skills
  • Self-motivated and proactive
  • Motivated by risk-based thinking, focused on safety and efficacy
  • Computer proficiency, including Word, Excel, Powerpoint, Google suite, Zoom etc.

About 3Oe:

Our team is dedicated to using natural products and creating eco-friendly technology that makes a positive impact on the health and wellbeing of our community and the people we love. Supported by 21 patents, our unique spray technology is fortified with point-of-use aqueous ozone created from pure water, to enhance the effectiveness of a hand hygiene program; as part of other healthy lifestyle choices, this helps to reduce the risk of transmission of infectious agents.

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