Post Market Surveillance Engineer (PowerBI & CAPA)
Roth Staffing Companies

Job Info

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Roth Staffing is looking for a Post Market Surveillance Engineer within the medical technologies firm.

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, non-conformances, 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:
Bachelor's Degree in in Engineering or Scientific field including either industry or industry/education, minimum of 2 years' experience Required
-OR-
Master's Degree or equivalent in in Engineering or Scientific field including either industry or industry/education Required or internship, senior projects, or thesis Required

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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