Engineer II Quality
Engineer II Quality
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Job Description
Changing lives. Building Careers.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us change equals opportunity. Every day more than 4000 of us are challenging whats possible and making headway to help improve outcomes.
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 crossfunctional problemsolving 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.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully an individual must be able to perform each essential duty satisfactorily.
Primary responsibilities are to:
Maintains a thorough understanding of the following international standards and regional regulations:
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 Corporations 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.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully an individual must be able to perform each essential duty satisfactorily.
40: Facilitate and maintain the change management system. Complete quality impact assessments assure change controls are complete concise and ontime. 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 stateoftheart including but not limited to the following: 21CFR820 ISO 13485 Regulation 2017/745 (EUMDR) the Canadian Medical Device Regulations (CMDR) Integra Corporations policies and procedures and other applicable regulatory requirements.
5: Participate in internal and external audits.
MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge skill and/or ability required for this position.
Minimum of 5 years of experience.
Education: Bachelor of Science or higher; Masters 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 decisionmaking.
Demonstrates excellent organizational communication and project management skills. Produces highquality 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 stateoftheart.
Integra LifeSciences is an equal opportunity employer and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race marital status color religion sex age national origin sexual orientation physical or mental disability or protected veteran status.
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Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation please email us at or call us at.
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Employment Type
Full-Time
