Associate Post Market Surveillance Engineer

Integer Holdings; Plymouth (MN); On-site; USD 54,000 - 79,000; Full time

Benefits offered by this job

Medical Insurance (Health)

Dental Insurance

Vision Insurance

Disability Insurance

Life Insurance

Adoption benefits

401(k) with company matching

Holidays and PTO

Parental leave after 1 year

Job summary

Integer Holdings is seeking an Associate Post Market Surveillance Engineer to support complaint handling, regulatory reporting, and post market surveillance under guidance from senior staff. You will document complaints, assist in investigations, and help ensure compliance with FDA QSR and related regulations.

This role emphasizes data collection, cross-functional collaboration, and adherence to quality systems. The position offers growth within a quality-focused manufacturing environment.

Qualifications

• Minimum Education and Experience: Associate's or two-year degree and 0-3 years of experience. Candidates who do not meet the education requirement may be considered if they have a minimum of 3 years' relevant experience such as organizing and accurately controlling large amounts of detailed information and product handling.
• Specialized Knowledge: ability to work independently as well as collaboratively with other associates and cross functional teams.
• Specialized Skills: written and oral communications; competent with Microsoft Office and able to stay organized and focused on multiple projects.

Responsibilities

• Support Complaint Handling, Regulatory Reporting and Post Market Surveillance under guidance from experienced associates.
• Capture and document all complaints in the database; send acknowledgements.
• Track customer return products and assist in investigations with cross-functional teams.
• Assist data collection and root-cause investigations to support product quality and patient safety.
• Support timely closure of investigations to comply with FDA requirements and other authorities.
• Collaborate with internal/external customers to gather information for investigations.

Skills

Attention to detail

Written and oral communication

Independence

Cross-functional collaboration

Time management

Education

Associate's or two-year degree

Tools

Microsoft Office

Job description

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'll do in this role:

• The primary purpose of this job is to 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 providing guided assistance 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.

• 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 supporting complaint investigation activities with cross functional team members and sending complaint investigation reports.

• You will interface with internal and external customers to gather additional information required for complaint investigations and assist in preparing customer communication, as applicable.
• You will assist in the data collection, root cause investigations and resolution in support of a thorough complaint investigation related to product quality and patient safety.

• You will support timely closure of complaint investigations to comply with FDA requirements and other regulatory bodies and countries.
• You are expected to collaborate with others in the exchange of information, ask questions and regularly check for understanding in support in your development and a Post Market Surveillance Engineer.

Audit Support:

• You will assist in internal and external audits by compiling and organizing complaint data.
• You will be mentored to participate in internal audits.

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 Post Market 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 differentiated quality.

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

Integer's Manufacturing Excellence and Market Focused Innovation Strategies:

• 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 journey to differentiated quality.
• Leadership of Sustained Change ensuring customer change notifications are initiated and completed, as necessary, and supporting continuous improvement activities as required.
• Support the standardization 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, behavior-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.

What sets you apart:

Minimum Education and Experience:

• You have earned, as a minimum, an Associate's or two-year degree and have between 0-3 years of experience. Candidates who do not meet the education requirement may be considered if they have a minimum of 3 years' relevant experience such as organizing and accurately controlling large amounts of detailed information and product handling.

Specialized Knowledge:

• While you will have regular 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.

Salary range: $54,000 - $79,200

#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.