Quality Assurance Specialist, Process Optimization
12 hours ago
We are seeking a highly skilled Quality Assurance Specialist to join our team at Integra LifeSciences. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and efficacy of our medical products.
Key Responsibilities- Maintain a thorough understanding of key international standards and regional regulations, including FDA QMSR (21 CFR Part 820), data integrity principles, ISO 13485, Regulation 2017/745 (EUMDR), Canadian Medical Device Regulations (CMDR), Integra Corporation's policies and procedures, and other applicable regulatory agency requirements.
- Support the launch of new or improved products/processes, facilitating technology transfer from development to commercialization from a quality and manufacturing perspective.
- Manage changes in device design and manufacturing procedures for commercialized devices at the Columbia, MD site.
- Author, edit, and provide guidance on the development and implementation of new and updated documents, including validation protocols and reports, product specifications, design documentation, SOPs, quality investigations, plans, and QMS support documents.
- Investigate quality events using a systematic approach to determine root causes and develop objective evidence for data-driven decision making.
- Develop statistically based sampling plans for product testing, inspections, validations, and other applications, providing statistical analysis to support Quality Systems documentation.
- Prepare monthly and quarterly trending data and analysis reports, including Statistical Process Control documentation, and support the Quality Management Review Process.
- Participate in FDA inspections, ISO Certification and surveillance audits, and customer audits.
- Perform other Quality Assurance and Quality Engineering-related duties as required.
- 5+ years of experience in a relevant role.
- Bachelor of Science or higher; Master's degree preferred. Education requirements may be reduced considering years of experience.
- American Society for Quality (ASQ) or Regulatory Affairs Professionals (RAPS) certifications or similar are preferred. Candidates without certification must demonstrate technical competency by obtaining a relevant certification within the first year of employment.
- Technical specialization in change management and data integrity, systems development/validation, or data integration/trending.
- Demonstrated knowledge of statistically based sampling plans, analytical tools, and data-driven decision making.
- Excellent organizational, communication, and project management skills, with the ability to produce high-quality work in a timely manner.
- Knowledge of data integrity principles and proficiency in coding/scripting, particularly in validating complex data management networks.
- Familiarity with electronic quality management systems, enterprise resource management systems, and the Microsoft suite of applications.
- Ability to work independently with minimal supervision.
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