Quality Manager
3.
5 Quick Apply Full-time 11 hours ago Full Job Description InfuSystem is a growing healthcare company that provides infusion pumps and related products and services for patients in hospitals, clinics, ambulatory surgery centers, and other sites of care from five locations serving all 50 states and Canada.
We deliver improved patient outcomes and high patient satisfaction.
As a leader in our field, our mission is to provide quality infusion services to patients and medical practices, including a 24-hour clinical support hot line.
Service is always our highest priority.
Patients and clinicians in more than 1,800 sites of care trust InfuSystem as their full-service source for cost-effective infusion pump services.
Summary:
The Quality Manager assures the Company remains compliant with regulations and internal quality policies; supporting activities consistent with company objectives.
This role supports the Director of Compliance and Quality in all daily quality activities as detailed below.
IN THIS ROLE, THE IDEAL CANDIDATE WILL:
Oversees the performance of the Quality Management System across all sites for assurance of compliance with ISO 9001; 2015 and ISO 13485; 2016.
Facilitates the quarterly quality and performance improvement meetings Oversees the performance of internal audits by external vendors; Addresses any findings with the stakeholders in the respective areas; Leads root cause analysis exercise for findings Follows up on actions and performs effectiveness checks Oversees the performance of suppliers Trends performance May perform onsite supplier audits Drives corrective actions with supplier to drive performance Oversees responses to manufacturer recalls and performance of recall remediation activities Oversees performance of product complaint analysts and ensures team meets requirements for reporting timelines for both FDA and Health Canada.
Collaborates with internal teams on any trends identified and drives improvement by addressing trends with effective corrective action.
Responds to compliance and quality inquiries including, creating regulatory letters for responses to import/export activities, creating communication to customers and/or patients as needed.
Responsible for prompt response to recalls and OEM notifications and corrections including ensuring communication to Recall Committee and customers is performed in a timely manner.
Maintains accurate records of any recall activity including notification.
May collaborate with leadership from Biomed on recall remediation activities.
Manages and leads all third party and regulatory audits and inspections such as customer audits, unannounced FDA visits, Health Canada inspections, Boards of Pharmacy inspections, and any other regulatory or government body.
Responsible for ensuring training content is accurate and current for procedures where Quality is responsible.
May perform training as needed.
Ensures direct reports are current on required training.
SUPERVISORY
Responsibilities:
Manages the Quality team Monitors spending within the annual budget.
THE IDEAL CANDIDATE WILL HAVE THE FOLLOWING
Qualifications:
Bachelor's Degree from four-year college or technical school and 3-5 years previous experience in a quality leadership position preferably in the medical device field.
Certified auditor for ISO 9001; 2015 required.
Certified auditor for ISO 13485; 2016 required.
Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement Influence - ability to influence multiple stakeholders at varying levels including ensuring a thorough understanding of what's needed in certain circumstances to ensure compliance and an ability to effectively and professionally communicate at all levels of the organization Design - Uses feedback to suggest modifications/improvements to Demonstrates attention to detail.
Problem Solving - Gathers and analyzes information skillfully; Works well in group problem solving Technical Skills - Pursues training and development opportunities to support knowledge of quality, compliance, and/or other regulatory agencies; Strives to continuously build knowledge and Teamwork - Contributes to building a positive team spirit; Collaboratively works across the organization in a supportive effort.
Strategic Thinking - Follows organizational strategy to achieve organizational goals while maintaining compliance; Adapts to changing conditions and is flexible.
Studies and understands departmental processes governed by the Quality Management System and the Scope of the certifications.
Strong technical skills tied to Microsoft office products; particularly excel and word.
Motivation - Sets and achieves challenging goals in agreement with Management.
Travel - Must be able to travel up to approximately 15% of the time with overnight travel.
PERSONAL AND PROFESSIONAL ATTRIBUTES:
The ideal candidate must be a rigorous analytical thinker and problem solver with the following professional attributes:
Strong work ethic Sound judgment Proven written and verbal communication skills Natural curiosity to pursue issues and increase expertise Pursue and design innovative analytical performance metrics The courage to promote and defend ideas and analyses Passionate about InfuSystem and serving customers and patients Strives to make an impact on improving our business processes and results Exemplary honesty and integrity Ability to collaborate effectively and work selflessly as part of a team PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
COMPREHENSIVE BENEFIT PACKAGE:
At InfuSystem, we give our employees the tools to succeed both on and off the job.
Our generous benefits package provides comprehensive coverage to help you protect your health and earning power and prepare for the future.
In addition, we offer perks and programs that help you grow in your career and make InfuSystem a great place to work! Health plan options that include an employer contribution Health Savings Account (HSA) Healthcare and Dependent Care Flexible Spending Accounts (FSA) Dental and Vision premiums covered by InfuSystem Life Insurance, STD & LTD Paid Parental Leave Adoption and Fertility Assistance 401(k) with a specified Company Match Employee Stock Purchase Program Tuition Assistance Generous Paid Time Off plan Employee Assistance Program Competitive Pay Employee Referral Bonus Spot Bonus Program Experience Required 3 - 5 years:
Experience operating in a healthcare quality leadership role Education Required Bachelors or better Skills Required Problem Solving Critical Thinking Analytical Thinking Behaviors Required Leader:
Inspires teammates to follow them Functional Expert:
Considered a thought leader on a subject Detail Oriented:
Capable of carrying out a given task with all details necessary to get the task done well Quick Apply.
Estimated Salary: $20 to $28 per hour based on qualifications.
5 Quick Apply Full-time 11 hours ago Full Job Description InfuSystem is a growing healthcare company that provides infusion pumps and related products and services for patients in hospitals, clinics, ambulatory surgery centers, and other sites of care from five locations serving all 50 states and Canada.
We deliver improved patient outcomes and high patient satisfaction.
As a leader in our field, our mission is to provide quality infusion services to patients and medical practices, including a 24-hour clinical support hot line.
Service is always our highest priority.
Patients and clinicians in more than 1,800 sites of care trust InfuSystem as their full-service source for cost-effective infusion pump services.
Summary:
The Quality Manager assures the Company remains compliant with regulations and internal quality policies; supporting activities consistent with company objectives.
This role supports the Director of Compliance and Quality in all daily quality activities as detailed below.
IN THIS ROLE, THE IDEAL CANDIDATE WILL:
Oversees the performance of the Quality Management System across all sites for assurance of compliance with ISO 9001; 2015 and ISO 13485; 2016.
Facilitates the quarterly quality and performance improvement meetings Oversees the performance of internal audits by external vendors; Addresses any findings with the stakeholders in the respective areas; Leads root cause analysis exercise for findings Follows up on actions and performs effectiveness checks Oversees the performance of suppliers Trends performance May perform onsite supplier audits Drives corrective actions with supplier to drive performance Oversees responses to manufacturer recalls and performance of recall remediation activities Oversees performance of product complaint analysts and ensures team meets requirements for reporting timelines for both FDA and Health Canada.
Collaborates with internal teams on any trends identified and drives improvement by addressing trends with effective corrective action.
Responds to compliance and quality inquiries including, creating regulatory letters for responses to import/export activities, creating communication to customers and/or patients as needed.
Responsible for prompt response to recalls and OEM notifications and corrections including ensuring communication to Recall Committee and customers is performed in a timely manner.
Maintains accurate records of any recall activity including notification.
May collaborate with leadership from Biomed on recall remediation activities.
Manages and leads all third party and regulatory audits and inspections such as customer audits, unannounced FDA visits, Health Canada inspections, Boards of Pharmacy inspections, and any other regulatory or government body.
Responsible for ensuring training content is accurate and current for procedures where Quality is responsible.
May perform training as needed.
Ensures direct reports are current on required training.
SUPERVISORY
Responsibilities:
Manages the Quality team Monitors spending within the annual budget.
THE IDEAL CANDIDATE WILL HAVE THE FOLLOWING
Qualifications:
Bachelor's Degree from four-year college or technical school and 3-5 years previous experience in a quality leadership position preferably in the medical device field.
Certified auditor for ISO 9001; 2015 required.
Certified auditor for ISO 13485; 2016 required.
Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement Influence - ability to influence multiple stakeholders at varying levels including ensuring a thorough understanding of what's needed in certain circumstances to ensure compliance and an ability to effectively and professionally communicate at all levels of the organization Design - Uses feedback to suggest modifications/improvements to Demonstrates attention to detail.
Problem Solving - Gathers and analyzes information skillfully; Works well in group problem solving Technical Skills - Pursues training and development opportunities to support knowledge of quality, compliance, and/or other regulatory agencies; Strives to continuously build knowledge and Teamwork - Contributes to building a positive team spirit; Collaboratively works across the organization in a supportive effort.
Strategic Thinking - Follows organizational strategy to achieve organizational goals while maintaining compliance; Adapts to changing conditions and is flexible.
Studies and understands departmental processes governed by the Quality Management System and the Scope of the certifications.
Strong technical skills tied to Microsoft office products; particularly excel and word.
Motivation - Sets and achieves challenging goals in agreement with Management.
Travel - Must be able to travel up to approximately 15% of the time with overnight travel.
PERSONAL AND PROFESSIONAL ATTRIBUTES:
The ideal candidate must be a rigorous analytical thinker and problem solver with the following professional attributes:
Strong work ethic Sound judgment Proven written and verbal communication skills Natural curiosity to pursue issues and increase expertise Pursue and design innovative analytical performance metrics The courage to promote and defend ideas and analyses Passionate about InfuSystem and serving customers and patients Strives to make an impact on improving our business processes and results Exemplary honesty and integrity Ability to collaborate effectively and work selflessly as part of a team PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
COMPREHENSIVE BENEFIT PACKAGE:
At InfuSystem, we give our employees the tools to succeed both on and off the job.
Our generous benefits package provides comprehensive coverage to help you protect your health and earning power and prepare for the future.
In addition, we offer perks and programs that help you grow in your career and make InfuSystem a great place to work! Health plan options that include an employer contribution Health Savings Account (HSA) Healthcare and Dependent Care Flexible Spending Accounts (FSA) Dental and Vision premiums covered by InfuSystem Life Insurance, STD & LTD Paid Parental Leave Adoption and Fertility Assistance 401(k) with a specified Company Match Employee Stock Purchase Program Tuition Assistance Generous Paid Time Off plan Employee Assistance Program Competitive Pay Employee Referral Bonus Spot Bonus Program Experience Required 3 - 5 years:
Experience operating in a healthcare quality leadership role Education Required Bachelors or better Skills Required Problem Solving Critical Thinking Analytical Thinking Behaviors Required Leader:
Inspires teammates to follow them Functional Expert:
Considered a thought leader on a subject Detail Oriented:
Capable of carrying out a given task with all details necessary to get the task done well Quick Apply.
Estimated Salary: $20 to $28 per hour based on qualifications.
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