Post Market Surveillance Engineer II

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




What you’ll do in this role:

• The primary purpose of this job is to execute and 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 executing and providing support 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 with some instruction and guidance from more experienced associates and managers.

• 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.

_Post Market Complaint Handling Activities:_

• 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 performing complaint investigation activities with cross functional team members.

• You will be responsible for reviewing device history records for nonconformities related to the alleged complaint.

• You will interface with internal and external customers to gather additional information required for complaint investigations and prepare customer communication, complaint investigation reports and Customer Facing Reports, as applicable.

• You will execute data collection, root cause investigations and resolution in support of a thorough complaint investigation related to product quality and patient safety.

• You will play an active role in ensuring timely closure of complaint in...

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