What are the responsibilities and job description for the Sr. Quality Engineer position at Ingersoll Rand?
Ingersoll Rand is committed to achieving workforce diversity reflective of our communities. We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sex (including pregnancy), sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.
JOB DESCRIPTION : The Sr. Quality Engineer is responsible for the full range of Quality Engineering Support ensuring compliance to validation activities, including facility transfer, cleanroom requirements, performing internal and external audits, risk assessments, company-wide training, and other BU project related tasks, as needed. Additionally, this position is responsible for ensuring proper compliance to documentation, reporting, and data analysis as it relates to medical device validation, qualification, reporting and data analysis as it relates to customer requests and requirements.
KEY ROLE AND RESPONSIBILITIES:
JOB DESCRIPTION : The Sr. Quality Engineer is responsible for the full range of Quality Engineering Support ensuring compliance to validation activities, including facility transfer, cleanroom requirements, performing internal and external audits, risk assessments, company-wide training, and other BU project related tasks, as needed. Additionally, this position is responsible for ensuring proper compliance to documentation, reporting, and data analysis as it relates to medical device validation, qualification, reporting and data analysis as it relates to customer requests and requirements.
KEY ROLE AND RESPONSIBILITIES:
- Responsible for developing, maintaining and executing on quality procedures to inspect and report quality issues
- Oversees maintenance of the requirements and monitors the effectiveness of the ISO 13485 quality system as well as drives continuous improvement and maintenance of the system
- Oversees the development and management of the FMI QMS to ensure compliance with relevant regulatory bodies.
- Accomplishes quality assurance human resource objectives by recruiting, selecting, orienting, training, scheduling, coaching, counseling, and disciplining employees; communicates job expectations and leads team in talent and performance management processes
- Assigned as the Management Representative of FMI.
- Hosts customer and registrar audits, as well as coordinates and performs internal quality and supplier audits as needed
- Leads all internal and external CAPA’s, NCR’s, and customer complaints including investigation, root cause analysis, and other related documentation.
- Ensures all document control and revision control activities are carried out to ensure compliance
- Ensures all products conform to validated processes and DMR’s, as well as performs lot release and related functions
- Assures the reliability and consistency of production by checking processes and final output
- Provides oversight of calibration and preventive maintenance program to ensure compliance
- Collaborates with purchasing department and co-manages the approved supplier list and evaluates them to ensure product compliance
- Monitors approved supplier list and rates suppliers through score card ratings
- Ensures all SOP’s and process documentation are created in accordance with the QMS and works with all departments to ensure effectiveness
- Updates job knowledge by studying trends in and developments in quality management, participating in educational opportunities, reads professional publications and participates in professional organizations and networking opportunities
- Demonstrates all of Flexan’s corporate values:
- We have an engaged culture
- We embrace the rigor to be safety and quality driven in all we do
- We embrace the choice to work here
- We operate with transparency, ethics, and integrity
- We consistently meet our expectations
- Bachelor’s degree required (advance degree, Engineering or other technical field strongly preferred).
- 5 years significant professional experience in continuous quality improvement with progressive scope and responsibility (preferably in one or more medical products).
- ISO 13485 and Good Manufacturing Practices (experience with FDA 21CFR820 is a plus).
- Proficient in Microsoft Office applications.
