Post Market Surveillance Engineer II

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 for understanding in support of your development as an Associate Product Surveillance Engineer.

• You embed Quality within the Regulatory discipline - "I own 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 5 Sigma.

• You may perform other duties as needed and as directed by your line of supervision.

Manufacturing Excellence Imperatives:

• Provide support of Integer's Manufacturing Excellence and Market Focused Innovation Strategies

• Participation or Leadership in Site Hoshin Planning, Quality Planning, Validation master plans and associated quality improvement imperatives

• Provide leadership as required for QA RA weekly and monthly metrics, supporting the walk to 5 sigma.

• Leadership of Sustained Change ensuring customer change notifications are initiated and completed, as necessary, and supporting continuous improvement activities as required.

• Support the standardisation of workplace organization & visual controls (5S), Manufacturing Standard Work, and robust training & certification programs where applicable.

• Associate Engagement promoted through the adoption of standardized problem solving. methodologies, behaviour-based safety programs, and improvement idea and suggestion systems.

• Systems & Process Optimization through adoption of principles of built in quality,

How you will be measured:

The specific measures listed below may be subject to change and are not intended to be an all-inclusive list.

• Safety is our highest priority; you will be an active supporter of the Integer Environmental, Health & Safety programs.

• Adhere to all Integer Values: Customer, Integrity, Candor, Inclusion, Collaboration, Innovation.

• You will have defined Goals and Objectives specifying key projects and expected milestones to achieve.

• Achievement of site quality KPI's

• Innovation and ideation are critical aspects of your role, and you will be expected to generate continuous improvement suggestions and support the implementation of them.

What sets you apart:

Minimum Education and Experience:

• You have earned, as a minimum, a bachelor's degree and have at least 1 year of relevant experience. Candidates who do not meet the education requirement may be considered if they have a minimum of 3 years' relevant experience (medical device or other regulated industry experience preferred).

Specialized Knowledge:

• While you will have occasional support and guidance from more experienced Post Market Surveillance professionals, supervisors or managers, you will demonstrate the ability to work independently as well as collaboratively with other associates and cross functional teams.

Specialized Skills:

• You demonstrate a solid technical aptitude with the ability to be an effective contributor to a team or produce results of a technical nature as an individual.

• You demonstrate competencies in both written and oral communications.

• You are highly organized and able to work and track multiple projects and complaints simultaneously.

• You possess intermediate to advanced skills using Microsoft Office (PowerPoint, Visio, Project, Excel, Word, etc.)

• You possess a positive, can-do attitude with an underlying belief that failure is not an option.

#IND1