Akkodis is recruiting for 5 Medical Device Quality Complaints Analysts in Skaneateles, NY.
In this role, you will primarily be responsible for investigation, review, and completion of all Quality Engineering complaint issue analysis tasks utilizing various quality system inputs.
Review individual complaints and associated service data to determine risk level and complete investigation into the as determined problem code and cause codes for each complaint.
The hourly rate for this Medical Quality Support Analyst role is $22 - $28/hour. The rate may be negotiable based on experience, education, geographic location, and other factors.
Required Skills and abilities for the Medical Device Quality Complaints Analyst role include:
Medical Device Experience with knowledge of 21CFR820 preferred. • Investigational research skills • Experience with any statistical software packages (Minitab a plus) • Desired experience in the medical device industry in the development and deployment of Quality Systems, and process controls, and continuous improvement methods. • Knowledge and working application of FDA cGMP; ANSI/ISO/ASQC requirements; CMDAS (optional). • Demonstrated strong analytical problem solving (Root Cause Investigations). • Computer competency in Word, Excel, Power Point, Minitab, Access and databases.
EDUCATION/EXPERIENCE REQUIRED • A Bachelor of Science degree in Engineering unless candidate has extensive Complaints experience • 1-3 years of Medical Device experience
Responsibilities for this Medical Device Quality Complaints Analyst role include: • Analyze data from various quality inputs (including but not limited to: Field Corrective Action (FCA), Complaints, FDA Medical Device Reports (MDR), etc.) to determining trends and systemic issues. • Prepare and issue reports based on information analysis. • Review existing investigation reports and identify gaps for GMP compliance. Develop strategies and plans to close the gaps in an efficient and technical manner. • Develop and communicate expectations for quality performance, continuous improvement and process controls for marketed products. • Monitor and drive corrective action and continuous improvement activities that directly impact performance measures by performing primary investigations, conducting data analysis, and implementing corrective actions. • Conduct or lead corrective and preventive actions in manufacturing using formal problem-solving tools and documentation. • Support CAPA and maintenance activities for existing product lines.
Recommend and/or support projects for improvements to the quality system as approved by management.
If you are interested in this Medical Device Quality Complaints Analyst job, then please click APPLY NOW. For other opportunities available at Akkodis go to www.akkodis.com. If you have questions about the position, please contact Mike Keegan at 585-465-1236 or michael.keegan@akkodisgroup.com
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan.
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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements