Post Market Surveillance Engineer II

About the 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.

Responsibilities

• Accurately capture and document all complaints in the complaint handling database according to internal policies and procedures.
• Sending complaint acknowledgements to customers.
• Tracking customer return products.
• Performing complaint investigation activities with cross-functional team members.
• Reviewing device history records for nonconformities related to the alleged complaint.
• Interfacing with internal and external customers to gather additional information required for complaint investigations and preparing customer communication, complaint investigation reports, and Customer Facing Reports, as applicable.
• Executing data collection, root cause investigations, and resolution in support of a thorough complaint investigation related to product quality and patient safety.
• Playing an active role in ensuring timely closure of complaint investigations to comply with requirements of FDA and other regulatory bodies and countries.
• Handling, decontaminating, and analyzing products used in the field by hospitals/end users per internal procedures and safety requirements, which will require you to have relevant vaccinations.
• Performing risk assessments for products that are Integer owned designs.
• Performing CAPA assessments and supporting CAPA investigations.
• Assessing Adverse Event Reportability decisions in accordance with US and International regulations.
• Assisting in the completion of applicable forms for submission of reportable complaints to applicable agencies.
• Assisting in gathering complaint and ship data to support Post Market Trending, PMSRs, and PSUR's.
• Collaborating with others in the exchange of information, asking questions, and regularly checking for understanding in support of your development as a Post Market Surveillance Engineer II.
• Supporting internal and external audits.
• Providing support for external regulatory inspections and customer audits.
• Supporting the timely response and closure of audit observations and findings.
• Performing work on projects where you will follow Integer’s standard quality management system methodologies to investigate opportunities for process improvements.
• Supporting the standardization of workplace organization & visual controls (5S), Manufacturing Standard Work, and robust training & certification programs where applicable.
• Providing 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.
• Leadership of Sustained Change ensuring customer change notifications are initiated and completed, as necessary, and supporting continuous improvement activities as required.
• Engage in continuous improvement suggestions and support their implementation.

Qualifications

• 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).
• 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.

Skills

• Technical aptitude
• Effective communication skills
• Organizational skills
• Intermediate to advanced Microsoft Office skills

Benefits

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.

Pay

Details about pay are not specified in the job posting.

Schedule

Details about schedule are not specified in the job posting.