Post Market Surveillance Engineer II

Integer • Chaska, MN

5d

About The Position

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.

Requirements

• Bachelor’s degree and at least 1 year of relevant experience.
• Alternatively, 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).
• Demonstrate the 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.

Nice To Haves

• Medical device or other regulated industry experience preferred.

Responsibilities

• Accurately capturing and documenting 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 for complaint investigations and prepare 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.
• 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 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.
• Embedding Quality within the Regulatory discipline – “I own Quality.”
• 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.
• Performing other duties as needed and as directed by your line of supervision.
• 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.
• Providing leadership 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.
• Supporting the standardization of workplace organization & visual controls (5S), Manufacturing Standard Work, and robust training & certification programs where applicable.
• Promoting Associate Engagement through the adoption of standardized problem solving methodologies, behaviour-based safety programs, and improvement idea and suggestion systems.
• Supporting Systems & Process Optimization through adoption of principles of built-in quality.

Benefits

• Medical
• Dental
• Vision
• Disability
• Life insurance
• Adoption benefits
• Parental leave (available after one year)
• Supplemental life insurance (optional employee-paid)
• Critical illness insurance (optional employee-paid)
• Hospital indemnity insurance (optional employee-paid)
• Accident insurance (optional employee-paid)
• 401(k) plan with company matching contributions
• 80 hours (10 days) of company designated holidays per year
• Annual allotment of paid time off

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level