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

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. 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.

Responsibilities

Post Market Complaint Handling Activities

• Accurately capture and document all complaints in the complaint handling database according to internal policies and procedures.
• Send complaint acknowledgements to customers.
• Track customer return products.
• Perform complaint investigation activities with cross-functional team members.
• Review device history records for nonconformities related to the alleged complaint.
• 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.
• Execute data collection, root cause investigations, and resolution in support of a thorough complaint investigation related to product quality and patient safety.
• Ensure timely closure of complaint investigations to comply with requirements of FDA and other regulatory bodies and countries.
• 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.
• Perform risk assessments for products that are Integer-owned designs.
• Perform CAPA assessments and support CAPA investigations.
• Assess Adverse Event Reportability decisions in accordance with US and International regulations.
• Assist in the completion of applicable forms for submission of reportable complaints to applicable agencies.
• Assist in gathering complaint and ship data to support Post Market Trending, PMSRs, and PSUR’s.
• Collaborate with others in the exchange of information, ask questions, and regularly check for understanding in support of your development as a Post Market Surveillance Engineer II.

Audit Support

• Support 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

• Perform work on projects following Integer’s standard quality management system methodologies to investigate opportunities for process improvements.
• 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.
• Embed Quality within the Regulatory discipline – “I own Quality.”
• Act as 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 KPIs and journey to 5 Sigma.

Manufacturing Excellence Imperatives

• Provide support of Integer’s Manufacturing Excellence and Market Focused Innovation Strategies.
• Participate or lead 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.
• Lead Sustained Change ensuring customer change notifications are initiated and completed, as necessary, and support continuous improvement activities as required.
• Support the standardization of workplace organization & visual controls (5S), Manufacturing Standard Work, and robust training & certification programs where applicable.
• Promote associate engagement through the adoption of standardized problem-solving methodologies, behavior-based safety programs, and improvement idea and suggestion systems.
• Support systems & process optimization through adoption of principles of built-in quality.

How You Will Be Measured

• 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.
• Achieve defined Goals and Objectives specifying key projects and expected milestones.
• Contribute to the achievement of site quality KPIs.
• Generate continuous improvement suggestions and support the implementation of them.

Requirements

• Minimum Education and Experience: Bachelor’s degree and 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).

Skills

• Ability to work independently as well as collaboratively with other associates and cross-functional teams.
• Solid technical aptitude with the ability to be an effective contributor to a team or produce results of a technical nature as an individual.
• Competencies in both written and oral communications.
• Highly organized and able to work and track multiple projects and complaints simultaneously.
• Intermediate to advanced skills using Microsoft Office (PowerPoint, Visio, Project, Excel, Word, etc.).
• Positive, can-do attitude with an underlying belief that failure is not an option.

Pay

Salary range: $70,950 - $104,060

Benefits

• Comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits.
• Parental leave available after one year.
• Optional employee-paid programs include supplemental life insurance, critical illness, hospital indemnity, and accident insurance.
• Immediate eligibility to participate in the 401(k) plan with company matching contributions.
• 80 hours (10 days) of company-designated holidays per year plus an annual allotment of paid time off.