Quality Engineer

Job Title

Pay Range: $47.10hr - $52.1hr

Requirement/Must Have:

• Bachelor of Science or higher; Master’s degree is preferred.
• Technical specialization in change management and data integrity, systems development/validation, or data/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.
• Ability to prioritize projects to meet organizational goals and objectives.
• Demonstrates knowledge of the principles of data integrity.
• Proficiency in the use of modern technology, especially electronic quality management systems, enterprise resource management systems, and the Microsoft suite of applications.
• Ability to work independently with minimal supervision.
• Knowledge of international standards and maintaining the currently recognized state-of-the-art.
• GMP experience required in controlled / regulated environments.
• Data Integrity experience is a huge plus.

Responsibilities:

• Support business operations by maintaining critical management systems and assuring the efficacy of established process control programs, including calibration and maintenance, change management, validation, and environmental monitoring.
• 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, and SOPs.
• Facilitate the development, implementation and monitoring of quality programs and policies to ensure compliance with applicable regional regulations, international standards, and corporate policies.
• Maintain a thorough understanding of international standards and regional regulations including FDA QMSR (21 CFR Part 820), principles of Data Integrity and 21 CFR Part 11, ISO 13485, Regulation 2017/745 (EUMDR), and CMDR.
• Support the launching of new or improved products/processes and facilitate the transfer of technology from development to commercialization.
• Facilitate management of changes in device design and manufacturing procedures for commercialized devices.
• Author, edit, and provide guidance on the development of validation protocols and reports, product & material specifications, design & development documentation, and quality investigations.
• Investigate Quality Events using a systematic approach to determine root causes.
• Develop objective evidence to supplement data driven decision making.
• Support development of statistically based sampling plans for product testing, inspections, and validations.
• Provide Statistical Analysis of data to support Quality Systems documentation such as validations, NCs, and Complaints.
• 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.
• Participate in FDA inspections, ISO Certification and surveillance audits, and customer audits.
• Facilitate and maintain the change management system, completing quality impact assessments and assuring change controls are complete and on-time.
• Perform Quality Investigations in response to quality events, implementing corrective and preventive actions.

Nice to Have:

• XX Society for Quality (ASQ) or Regulatory Affairs Professionals (RAPS) certificates.
• Coding/scripting proficiency and/or experience validating complex data management networks.

Skills:

• GMP.
• Data Integrity.
• ISO 13485.
• FDA QMSR (21 CFR Part 820).
• 21 CFR Part 11.
• EUMDR.
• CMDR.
• Statistical Process Control.
• Change Management.
• Validation.
• Quality Management Systems (QMS).
• Enterprise Resource Management Systems.
• Microsoft Office Suite.

Qualification And Education:

• Candidates who are not certified must demonstrate technical competency by obtaining a relevant certification from an accredited organization within the first year of employment.