Quality Engineer

3 weeks ago

Plymouth, United States Medix™ Full time

Summary Statement:

Join our dynamic team and play a pivotal role in ensuring the compliance of our Quality Management System (QMS). We're seeking a dedicated individual to collaborate closely with our small team, ensuring adherence to regulatory standards and maintaining the highest quality standards on-site, full-time. This role is crucial in upholding the Quality System Manual procedures and ensuring strict compliance with its stipulations.


Primary Responsibilities:

Complaint Handling and Returned Goods Authorizations (RGAs):

  • Oversee complaint handling module, managing the entire process from entry to investigation, reporting, and trend analysis.
  • Input complaint data into post-market surveillance records and coordinate returned goods authorizations, liaising with sales and marketing.
  • Conduct evaluations of returned devices.

Supplier Management:

  • Implement comprehensive supplier controls, including performance monitoring, credential reviews, and agreement establishment.
  • Develop risk-based sampling plans for receipt inspection procedures and manage supplier management system.
  • Conduct remote and on-site supplier audits, including planning and report generation.

Document Coordination, Reviews, and Approvals:

  • Facilitate formal Document Change Reviews (DCRs) using the Grand Avenue Software (GAS) platform.
  • Initiate and review DCRs for various documents, including SOPs, manufacturing procedures, and technical documentation.
  • Assist with GAS platform administration and manage different modules within it.

Corrective and Preventative Actions (CAPAs):

  • Investigate CAPAs, conduct root cause analyses, implement corrective/preventative actions, and verify their effectiveness.

Gap Assessments:

  • Review relevant standards, regulations, and guidance documents to assess their impact on QMS and implement necessary changes.

Non-Conforming Materials (NMRs):

  • Issue and approve NMR dispositions, including risk assessments and rework instructions. QMS Training Coordination:
  • Assist in coordinating training tasks, deliver training presentations, and oversee training quizzes.

Secondary Responsibilities:

  • Perform receiving inspection activities, manage electronic production inventory systems, and assist with purchasing activities.
  • Maintain and manage quality records related to QMS and production activities.
  • Participate in risk management activities and audits, including notified body, FDA, and internal audits.
  • Support management review processes through data analysis and presentation preparation.
  • Provide assistance with production operations, order fulfillment, and field action activities.


Qualifications:

  • Bachelor's degree in engineering or relevant discipline, or equivalent experience/certifications.
  • Experience in medical device industry with quality management systems.
  • Strong knowledge of medical device regulations, including EU MDR and US 21 CFR Part 820, as well as ISO 13485.
  • Experience with Grand Avenue Software (GAS) Electronic Quality Management System preferred but not required.
  • Ability to work independently and in a team environment, with excellent communication skills and proficiency in Microsoft Office applications.


Join our team and contribute to the maintenance of our high-quality standards in the medical device industry

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