Engineering - Engr II

Job Description:
Perform Post Market customer complaints investigations providing detailed analysis of the process and the data; determine root causes of the nonconformities in order to establish corrective and preventive actions. Execute complaint investigations multifunctional approach and issues addressed in a systematic methodical manner. Oversight of all complaints that require investigation through the different phases. Ensure on time completion of complaints. Work closely with complaint investigation owners to resolve issues and ensure those that have passed their due dates are addressed. Ensure complaint investigations are adequate and comply with applicable procedures.

Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and systems/procedures to optimize product development internal and external device manufacturing and device distribution. Please refer to the job description for additional details.

Key Responsibilities:
Investigate moderately complex product quality and compliance issues (e.g. CAPA nonconformances audit observations) for all production processes prior to final product release based on engineering principles; analyze results make recommendations and develop reports.
Develop update and maintain technical content of risk management files
Develop training and documentation materials for production (e.g. work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
Other incidental duties assigned by Leadership

Additional Skills:
Proficient at MS Suite especially Excel and Power Point
Experience with Power BI
Understanding of data trending and analytics data pulls/refresh data sources
Post market surveillance experience
General background/understanding of Post Market Analysis: Complaints FCA PRA CAPA
Understanding of regulations a plus; EUMDR FDA ISO standards
Medical device experience
Excellent writing skills
Ignite preferred
ETQ (Reliance) experience preferred

Education and Experience:
Bachelors Degree in in Engineering or Scientific field including either industry or industry/education minimum of 2 years experience Required

Or

Masters Degree or equivalent in in Engineering or Scientific field including either industry or industry/education Required or internship senior projects or thesis Required

Trinus Corporation a leading provider of technology solutions and services with over 25 years of experience is a certified WBE/MBE/SBE/SDB firm accredited by WBENC NMSDC and SBA. Our mission is to shape the future of work by aligning the right mix of people process technology and innovation to efficiently meet our clients business objectives. At Trinus we understand that finding the right opportunity is pivotal in your career journey. Our staffing services go beyond mere placements; they are about matching your skills and aspirations with the perfect fit. To learn more about us please visit our website