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.   [br class="SCXW161163878 BCX8" style="margin: 0px; padding: 0px; user-select: text; white-space: pre;"]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:

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  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.

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  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. 

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  Facilitates management of changes in device design and manufacturing procedures for commercialized devices which the Columbia, MD site is responsible for.

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  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.

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  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.

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  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.

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  Develop, review, and approve validation documentation for new and existing products, processes, and equipment.

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  Prepare monthly and quarterly trending data and analysis reports, including Statistical Process Control documentation, and support the Quality Management Review Process.

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  Participate in FDA inspections, ISO Certification and surveillance audits, and customer audits.

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  Perform other Quality Assurance and Quality Engineering related duties as required.

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

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  Education: Bachelor of Science or higher; Master's degree is preferred.  Education requirements can be reduced considering years of experience in a relevant role.

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  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.

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  Experience: Technical specialization in change management and data integrity, systems development/validation, or data integration/trending.

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  Demonstrates an understanding of statistically-based sampling plans, application of analytical tools, and has a history of data driven decision-making.

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  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

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  Demonstrates knowledge of the principles of data integrity.  Coding/scripting proficiency and/or experience validating complex data management networks is desired.

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  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.

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  Must be able to work independently with minimal supervision. 

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.