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 investigations to comply with requirements of FDA and other regulatory bodies and countries.

You may be required to handle, decontaminate, and analyze products used in the field by hospitals/end users per internal procedures and safety requirements, which will require you to have relevant vaccinations.

You will be responsible for performing risk assessments for products that are Integer owned designs.

You will be responsible for performing CAPA assessments and supporting CAPA investigations.

You will be responsible for assessing Adverse Event Reportability decisions in accordance with US and International regulations.

You will be responsible for assisting in the completion of applicable forms for submission of reportable complaints to applicable agencies.

You will assist in gathering complaint and ship data to support Post Market Trending, PMSRs, and PSUR’s.You are expected to collaborate with others in the exchange of information, ask questions and regularly check for understanding in support in your development as a Post Market Surveillance Engineer II.Audit Support:

You will be responsible for supporting internal and external audits. Provide support for external regulatory inspections and customer audits. Support the timely response and closure of audit observations and findings.

Quality System Responsibilities:

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…