Quality Engineer II_US

Job Title: Quality Engineer II_US
Location (On-site, Remote, or Hybrid?): Columbia, MD (Onsite)
Contract Duration: Contract until 11/30/2026

SUMMARY DESCRIPTION
The Quality Engineer II will support business operations at the Columbia, MD site by maintaining critical management systems and assuring the efficacy of established process control programs, including calibration and maintenance, change management, validation, environmental monitoring, and others. Participate on and lead cross-functional, problem-solving investigation and development teams. Provide guidance on the development and implementation of new and updated Quality System procedures for ISO/QSR, such as validation documents, manufacturing procedures, product & material specifications, design & development documentation, SOPs, and task force projects. Facilitate the development, implementation and monitoring of quality programs and policies that ensure that the development, manufacture, and distribution of medical products is in compliance with applicable regional regulations, international standards, and corporate policies and procedures.

Primary responsibilities are to:

• Maintains a thorough understanding of the following international standards and regional regulations: [br class="SCXW76822161 BCX8" style="margin: 0px; padding: 0px; user-select: text; white-space: pre;"]FDA QMSR (21 CFR Part 820), principles of Data Integrity and 21 CFR Part 11, ISO 13485, Regulation 2017/745 (EUMDR), the Canadian Medical Device Regulations (CMDR), Integra Corporation's policies and procedures, and other applicable regulatory agency requirements.
• Supports the launching of new or improved products/processes, and facilitates the transfer of technology from development to commercialization from a Quality and manufacturing perspective.
• Facilitates management of changes in device design and manufacturing procedures for commercialized devices which the Columbia, MD site is responsible for.
• Authoring, editing, and providing guidance on the development and implementation of new and updated documents, including but not limited to, the following: validation protocols and reports, product & material specifications, design & development documentation, SOPs, quality investigations, plans, and QMS support documents.
• Investigate Quality Events. Use a systematic approach to determine root cause(s) and sequences of events. Develop objective evidence to supplement data driven decision making.
• Support development of statistically based sampling plans product testing, inspections, validations and wherever required. Provide Statistical Analysis of the data to support all Quality Systems documentation such as validations, NCs, Complaints, etc.
• Develop, review, and approve validation documentation for new and existing products, processes, and equipment.
• 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.

APPROXIMATE % WEIGHTING

• 40% Facilitate and maintain the change management system. Complete quality impact assessments, assure change controls are complete, concise, and on-time. Provide guidance and support strategic planning for implementation of changes to products and manufacturing processes.
• 25% Perform Quality Investigations in response to quality events, use good judgement and a systematic approach to determine appropriate corrections and root cause(s), implement corrective and preventive actions, and keep good records to ensure accurate event reconstruction.
• 15% Develop, review, and approve quality records, including SOPs, plans, protocols, and reports, supporting GxP manufacturing and development.
• 10% Support the efficacy of critical control programs. E.g.- calibration and preventive maintenance, environmental monitoring, change management, etc.)
• 5% Maintains a thorough understanding of the currently recognized state-of-the-art, including, but not limited to, the following: 21CFR820, ISO 13485, Regulation 2017/745 (EUMDR), the Canadian Medical Device Regulations (CMDR), Integra Corporation's policies and procedures, and other applicable regulatory requirements.
• 5% Participate in internal and external audits.

DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill and/or ability required for his position.

• Education: Bachelor of Science or higher; Master's degree is preferred. Education requirements can be reduced considering years of experience in a relevant role.
• Certifications: American Society for Quality (ASQ) or Regulatory Affairs Professionals (RAPS) certificates or similar are preferred. Candidates who are not certified must demonstrate technical competency by obtaining a relevant certification from an accredited certification organization, college, or university within the first year of employment.
• Experience: Technical specialization in change management and data integrity, systems development/validation, or data integration/trending.
• Demonstrates an understanding of statistically-based sampling plans, application of analytical tools, and has a history of data driven decision-making.
• Demonstrates excellent organizational, communication, and project management skills. Produces high-quality work in a timely manner. Able to prioritize projects to meet organizational goals and objectives
• Demonstrates knowledge of the principles of data integrity. Coding/scripting proficiency and/or experience validating complex data management networks is desired.
• Is well informed and proficient in the use of modern technology, especially electronic quality management systems, enterprise resource management systems, and the Microsoft suite of applications.
• Must be able to work independently with minimal supervision.
• Knowledge of international standards and maintaining the currently recognized state-of-the-art