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’lldo in this role:

• The primary purpose of this job is toexecute 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 forexecuting and providing support in the analysis, evaluation and product investigation of complaints received from externalcustomersin a timely mannerto comply withFDA 21 CFR(QSR)requirements and requirements of other regulatory bodies andcountrieswith some instruction and guidance from more experienced associates and managers.

• You adhereto 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 foraccurately capturing and documenting allcomplaints in the complaint handling database according to internal policies and procedures.

• You will be responsible forsending complaint acknowledgements to customers.

• You will be responsible fortracking customer return products.

• You will be responsible forperformingcomplaint investigation activities with cross functional team members.

• You will be responsible forreviewing device history recordsfor nonconformities related to the alleged complaint.

• You will interface withinternal and external customers to gather additionalinformation requiredfor complaint investigations and preparecustomer communication,complaint investigation reportsand Customer Facing Reports,as applicable.

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

• You will play an active role in ensuringtimelyclosure of complaint investigations to comply withrequirements of FDA and other regulatory bodies and countries.

• You may be requiredto 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 forperforming risk assessments for products that are Integer owned designs.

• You will be responsible forperforming CAPA assessments and supportingCAPA investigations.

• You will be responsible forassessing Adverse Event Reportability decisions in accordance withUS 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 assistin gathering complaintand 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 EngineerII.

Audit Support:

• You will be responsible forsupporting internal and external audits. Provide support for external regulatory inspections and customer audits. Support the timelyresponse and closure of audit observations and findings.

Quality System Responsibilities:

• You will performwork onprojects 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 Regulatorydiscipline - “I own Quality.” You are astandard bearer for Quality in everything we do at Integer, by assuring adherence to our Quality Management System (QMS), facilitatingand/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 performother duties as needed and as directedby your line of supervision.

Manufacturing ExcellenceImperatives:

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

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

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

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

• Support the standardisation of workplace organization & visualcontrols (5S), Manufacturing Standard Work, and robust training & certificationprograms 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 builtin 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, abachelor’sdegree and have at least 1 yearof 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 occasionalsupport and guidance from more experienced Post Market Surveillance professionals, supervisorsor managers, you will demonstratethe ability to work independently as well as collaboratively withother associates andcross functional teams.

Specialized Skills:

• You demonstratea 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 demonstratecompetencies in bothwritten and oral communications.

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

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

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

Salary range $70,950 - $104,060

#IND1

Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success. Our compensation program includes base salary and a cash-based incentive program supporting our pay-for-performance philosophy. We provide a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits. Parental leave is available after one year. Optional employee-paid programs include supplemental life insurance, critical illness, hospital indemnity and accident insurance. Employees are immediately eligible to participate in the 401(k) plan with company matching contributions. We provide 80 hours (10 days) of company designated holidays per year plus an annual allotment of paid time off.

U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.