Associate Post Market Surveillance Engineer

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success. At Integer, our values are embedded in everything we do.

• Customer We focus on our customers’ success
• Innovation We create better solutions
• Collaboration We create success together
• Inclusion We always interact with others respectfully
• Candor We are open and honest with one another
• Integrity We do the right things and do things right

The primary purpose of this job is to support the Complaint Handling, Regulatory Reporting and Post Market Surveillance processes for Integer under the direction, instruction and guidance from more experienced associates and managers in your organization. This position will be responsible for providing guided assistance in the analysis, evaluation and product investigation of complaints received from external customers in a timely manner to comply with FDA 21 CFR (QSR) requirements and requirements of other regulatory bodies and countries.

You adhere to Integer’s Values and all safety, environmental, security and quality requirements including, but not limited to:
Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.

• You will be responsible for accurately capturing and documenting all complaints in the complaint handling database according to internal policies and procedures.
• You will be responsible for sending complaint acknowledgements to customers.
• You will be responsible for tracking customer return products.
• You will be responsible for supporting complaint investigation activities with cross functional team members and sending complaint investigation reports.
• You will interface with internal and external customers to gather additional information required for complaint investigations and assist in preparing customer communication, as applicable.
• You will assist in the data collection, root cause investigations and resolution in support of a thorough complaint investigation related to product quality and patient safety.
• You will support timely closure of complaint investigations to comply with FDA requirements and other regulatory bodies and countries.
• You are expected to collaborate with others in the exchange of information, ask questions and regularly check for understanding in support in your development and a Post Market Surveillance Engineer.

You will assist in internal and external audits by compiling and organizing complaint data. You will be mentored to participate in internal audits.

You will perform work on projects where you will follow Integer’s standard quality management system methodologies to investigate opportunities for process improvements. You are expected to collaborate with others in the exchange of information, ask questions and regularly check for understanding in support of your development as an Associate Post Market Surveillance Engineer. You embed Quality within the Regulatory discipline – “Iown Quality.”

You are a standard bearer for Quality in everything we do at Integer, by assuring adherence to our Quality Management System (QMS), facilitating and/or contributing to corrective and preventive actions, and contributing to the successful attainment of our quality KPI’s and journey to differentiated quality. You may perform other duties as needed and as directed by your line of supervision.

Provide support of Integer’s Manufacturing Excellence and…