Senior Quality Assurance Engineer

2 weeks ago

Flowery Branch, Georgia, United States medmix Full time

We are seeking a Senior Quality Assurance Engineer to contribute to the success of medmix. This role offers the opportunity to leverage your expertise in identifying improvement areas and presenting actionable recommendations to leadership. You will take charge of implementing these recommendations and evaluating their impact on the organization. If you possess a strong desire for personal growth, are highly organized, and excel in communication, you can play a vital role in advancing medmix's objectives.

Position Overview

The Quality Systems Lead will support the Healthcare division by designing and executing a compliant ISO 13485/21 CFR 820 quality framework. We are in search of a seasoned Quality Systems Manager with a robust background in the manufacturing sector. The ideal candidate is a driven professional capable of collaborating across departments to ensure the organization's quality systems are effectively managed. This role demands meticulous attention to detail and a dedication to efficient processes.

Key Responsibilities

  • Lead a team responsible for the daily upkeep of the quality management system while also developing quality initiatives that guarantee adherence to policies and ensure that service performance meets established internal and external standards.
  • Provide expertise and guidance in interpreting policies, regulatory frameworks, and internal guidelines to ensure compliance.
  • Collaborate directly with operational teams to offer ongoing process analysis oversight to enforce requirements and meet regulatory standards.
  • Oversee audit and inspection readiness, address audit findings, and coordinate with auditing bodies and inspectors throughout the audit process.
  • Prepare necessary documentation, including Corrective and Preventative Actions, and distribute to relevant stakeholders.
  • Manage and ensure the effectiveness of complaint handling, nonconformance, CAPA, document management, and record-keeping systems.
  • Drive root cause analyses and provide compliant solutions for resolving technical and quality issues in the laboratory, ensuring alignment with QMS and regulatory expectations.
  • Assist in the preparation of Management Reviews.
  • Review and approve investigations into complaints and root causes, as well as CAPAs.
  • Analyze, trend, and report data that supports the quality system (KPI's).
  • Draft, review, and approve Quality Agreements (QAG) with equipment vendors, method developers, and service providers.

Qualifications

Experience: 3-5 years of validation experience in a regulated manufacturing environment related to quality control of medical devices in accordance with ISO 13485 and 21 CFR 820.

Education: Bachelor's degree.

Additional Requirements

  • Preferred experience with injection molding processes, parameters, and troubleshooting.
  • In-depth knowledge of SOPs, cGMPs, and other compliance requirements and regulatory guidelines (FDA, EU) with the ability to navigate within a regulatory framework.
  • Experience with good documentation practices and cGMP standards is essential.
  • Comprehensive understanding of ISO 14971 from implementation through the device lifecycle.
  • Proficient in personal computer applications, particularly word processing, spreadsheets, presentations, and database software.
  • Experience in a clean room environment and conducting process and equipment validations.
  • Ability to perform tasks accurately and independently with minimal supervision.
  • Organized with a systematic approach to task execution and project management.
  • Self-motivated with effective time management skills to meet deadlines and work schedules.
  • Strong communication skills, both verbal and written, to effectively engage with all organizational levels and produce clear reports and policies.
  • Ability to collaborate effectively with colleagues across various departments.

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