Post Market Surveillance and QE

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Description

Job Title:

Post Market Surveillance and Quality Engineer

Department:
Regulatory Affairs

Reports to:

Post Market Regulatory Affairs Manager

FLSA Status:
Exempt

SUMMARY:

The Post Market Surveillance and Quality Engineer will be responsible for performing investigations related to Customer Complaints and Proactive Post Market Surveillance processes for Apyx Medical products.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Complaint Handling (70%):

* Perform complaint investigations for Apyx Medical through close collaboration with Research and Development, Manufacturing, Sales and Marketing and other departments;
Accountable for accuracy and quality of investigations;
Assure that medical device incidents/complaints are documented, reviewed, investigated, trended, and reported in accordance with current procedures.

* Use statistical techniques to analyze data and trends.

* Conduct complex investigations, coordinate and support Failure Investigations and participate in projects related to complaint handling.

* Assist in Customer Defect Tracking and Resolution to improve the overall customer experience.

* Coordinate flow of returned product for proper investigation; communicate as needed with OEM customers, distributors and doctors/nurses at user facilities.

Post Market Surveillance (15%):

* Contribute to post market surveillance activities. This includes the investigation of product malfunctions, product design and/or labeling problems, as well as customer dissatisfaction issues, and the regular monitoring and reporting of post market status and metrics. Monitor metrics based on performance trends.

* Perform trending and analysis as well as Post Market Surveillance activities including assisting in compiling reports for Apyx Medical products.

Process Improvement (10%):

* Work with a cross-functional team to implement robust solutions for process/device non-conformances;
Monitor complaint rates and initiate improvements where required;
Contribute to Feeder System metrics reviews;
Support improvement initiatives;
Participate directly or indirectly on project teams to develop, consolidate and/or improve complaint vigilance and related/interfacing processes and metrics.

* Participate in process improvements related to complaint/adverse events by collaborating across departments;
Use technical and product knowledge for accurate feedback for current product enhancements and future product development, and for escalation/awareness of issues;
Liaise with R&D and New Product Introduction teams to ensure new product readiness for complaint vigilance quality process support and other functions;
Support other related continuous improvement initiatives.

Other Duties as assigned (5%).

QUALITY ASSURANCE RESPONSIBILITIES:
The individual must comply with the following quality system requirements including, but not limited to:

* Use only formally approved procedures, records, documents and specifications known as "Controlled Documents" (e.g., device history records, data collection forms, drawings, procedures, and specifications).

* Use only properly calibrated and maintained equipment.

* Immediately bring to attention of the head of the Quality Assurance department any possible deviations from specified Standard Operating Procedures or Work Instructions he or she may notice.

* Follow all Standard Operating Procedures and Work Instructions relating to the functions preformed.

Requirements

QUALIFICATIONS:

The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities in the area of physical demands and work environment.

EDUCATION & EXPERIENCE:

Bachelor's Degree (BS) from a four-year college or university in Mechanical, Electrical, or Biomedical Engineering, or a Bachelor's Degree in Physics. 0-4 years of relevant experience.

ATTRIBUTES:

* Able to support change initiatives, develop strong effective relationships with key resources and decision makers.

* Knowledge of domestic and international quality systems and other standards such as FDA QSR, MDD, MDR, CMDCAS, SFDA, JPAL, ISO 13485, ISO 14971 and other applicable standards…