WI3665319

1

Unspecified

40

JOB REQUIREMENTS: Essential Duties and Responsibilities \* Supports
internal and external quality system audits. \* Supports various
elements of the Quality Management System, including: \* \* Incoming
product inspections \* \* Nonconforming product system, including
testing, in-market actions, and re-work. \* \* Complaints and post
market surveillance, including product evaluations. \* \* Tracking
service complaints and assisting with the device servicing record
closure \* \* Corrective/preventative action (CAPA), including sampling.
\* \* General Quality System Procedural Maintenance and projects \*
Assists in developing and maintaining written procedures, work
instructions, and other QMS documentation as required to define and
ensure conformance to customer and regulatory requirements. \* Performs
inspection of customer returned products and collaborates with
cross-functional teams to ensure accurate and timely complaint
investigations. Routine problem-solving to establish root cause of
respective complaints. \* Complete complaint investigations and product
evaluations in a timely manner. Reviews complaint supporting records
including production records to ensure accurate complaint
investigations, establishing root cause for respective complaints, trend
reviews, country reporting criteria, risk file reviews. \* Completes
Medical Device Record Decision trees within 48 hours of receipt and
prepares electronic submissions for internal approval. \* Tracking bed
servicing complaints and attaching respective DHRs to the servicing
complaint records. Performing due diligence and following up when
necessary. \* Escalates serious complaints to management in a timely
manner. Participates in Corrective and Preventative Action Activities
ensuring the appropriate product feedback loop is closed. \* Performs
routine analysis of post-market data and reports results to management.
Including active complaint monitoring on amazon and other social media
sources. Reasonable accommodations may be made to enable individuals
with disabilities to perform the essential function. An individual in
this position must be able to successfully perform the essential duties
and responsibilities listed above. Reasonable accommodations may be made
to enable individuals with disabilities to perform the essential
functions of this position. The above list reflects the general details
necessary to describe the principle and essential functions of the
position and shall not be construed as the only duties that may be
assigned for the position. Core Values & Guiding Principles \*
Understands internal and external customers \* Assure a safe work
environment \* Encourage individual development \* Demonstrates teamwork
and flexibility/adaptability \* Demonstrates honesty \* Keep our
commitments \* Think systemically and ensure\... For full info follow
application link. TIDI Products is an Equal Opportunity Employer -
Minorities/Females/Veterans/Disabled are encouraged to apply \*\*\*\*\*
APPLICATION INSTRUCTIONS: Apply Online: ipc.us/t/1DA6FD428ACE4251