Your responsibilities

Post Market Surveillance:

- Manage complaint system including intake, facilitation and communicating with the sales force, customer service and regulatory bodies, as required.

- Conduct complaint investigations to determine root cause and reportability requirements.

- Manage and execute post market surveillance duties including product holds, health hazard evaluations (HHE), field actions, and recalls. This includes communicating to appropriate regulatory bodies, as required.

- Generate periodic safety update reports (PSUR) and post market surveillance reviews (PMSR) to support regulatory requirements.

Distribution Quality: 

- Lead quality engineering efforts as it relates to distribution, logistics and inventory control.

- Utilize ERP systems to insure inventories are properly managed as it relates to quality initiated actions.

- Assist in developing and improving distribution related processes, methods and procedures.

Lead or participate on CAPA teams regarding quality system related non-conformances.

Assist subject matter experts (SME) in the development, authoring and releasing of procedures and work instructions used to define processes.

Gather and manage KPI/metric data used to measure the QMS.

Contribute on new product development projects as it pertains to quality related inputs and approvals.

Engage in both internal and external audits as a member of audit teams.

Understand, utilize and assist in maintaining document controls and change controls within the QMS.

Your qualifications

BS in Engineering or related field preferred, or equivalent in experience and training

Working knowledge of the medical device regulated industry, to include ISO 13485 and FDA 21CFR820 regulations

Basic knowledge of statistical and engineering principals

Strong analytical and problem solving skills

Strong proficiency in root cause analysis to include tools and methodology

Proficient in Microsoft Office applications