Associate Quality Systems Specialist - Brain Neurosurgery
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• Bachelor’s degree (Engineering, Quality/Regulatory, or Life Sciences preferred).
• 1+ years of experience in quality systems or quality control within a medical device, pharmaceutical or other FDA/GMP regulated industry
• 1+ year general laboratory experience.
• Familiarity with the handling of biohazardous materials preferred
• Familiarity or working knowledge of laboratory analytical methods and techniques.
• Moderate computer skills to navigate various systems and investigate the complaint records as needed. Examples of systems include: SAP and Trackwise.
• Proficient with computers to conduct through complaint investigations and research.
• Good working knowledge of MS Word, Excel and Power Point.
• Excellent verbal and written communication skills, including the ability to develop and present technical information necessary for the company.
• Good communication and follow-up skills to investigate and seek additional information for complaints.
• Ability to manage multiple tasks and complete daily work schedule actions in a timely manner.
• Ability to read, train to and apply all the regulatory requirements for Complaint Handling and Medical Device Reporting.
• Work in a team environment and foster team work.
• Ability to demonstrate a high standard for accountability, work ethic and dedication to tasks and assignments.
• Basic problem solving and investigation skills.
• Basic critical thinking skills.
• Good analytical skills including ability to analyze/identify problems and recommend solutions.
• Excellent interpersonal skills.
• Familiarity or working knowledge of FDA 21CFR 820, 803; ISO 13485, Medical Device Directive and applicable Harmonization Standards that apply to medical devices
The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.
ABOUT MEDTRONIC:
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
EEO STATEMENT:
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees
DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Must Have: Minimum Requirements
• Bachelor’s degree (Engineering, Quality/Regulatory, or Life Sciences preferred).
Preferred experience:
• 1+ years of experience in quality systems or quality control within a medical device, pharmaceutical or other FDA/GMP regulated industry
• 1+ year general laboratory experience.
• Familiarity with the handling of biohazardous materials preferred
• Familiarity or working knowledge of laboratory analytical methods and techniques.
• Moderate computer skills to navigate various systems and investigate the complaint records as needed. Examples of systems include: SAP and Trackwise.
• Proficient with computers to conduct through complaint investigations and research.
• Good working knowledge of MS Word, Excel and Power Point.
• Excellent verbal and written communication skills, including the ability to develop and present technical information necessary for the company.
• Good communication and follow-up skills to investigate and seek additional information for complaints.
• Ability to manage multiple tasks and complete daily work schedule actions in a timely manner.
• Ability to read, train to and apply all the regulatory requirements for Complaint Handling and Medical Device Reporting.
• Work in a team environment and foster team work.
• Ability to demonstrate a high standard for accountability, work ethic and dedication to tasks and assignments.
• Basic problem solving and investigation skills.
• Basic critical thinking skills.
• Good analytical skills including ability to analyze/identify problems and recommend solutions.
• Excellent interpersonal skills.
• Familiarity or working knowledge of FDA 21CFR 820, 803; ISO 13485, Medical Device Directive and applicable Harmonization Standards that apply to medical devices
Physical Job Requirements:
The physical demands described within the Responsibilities section of this job description 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.
• While performing the duties of this job, the employee is regularly required to be independently mobile.
• The employee is also required to interact with a computer, and communicate with peers and co-workers.
• While performing the duties of this job, the employee is regularly required to be independently mobile.
• The employee is also required to interact with a computer, and communicate with peers and co-workers.
RTG (Restorative Therapies Group) Overview
The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.
BRAIN THERAPIES offer an integrated portfolio of devices and therapies for the treatment of neurological disorders and diseases, as well as surgical technologies designed to improvethe precision and workflow of neuro procedures.
SPINE THERAPIES shape spine surgery for the better; delivering procedural solutions and therapeutic biologics and partnering with other healthcare stakeholders to accelerate innovations that can improve surgical efficiencies and help create better outcomes for more patients.
PAIN THERAPIES offer solutions — from early interventional procedures to implantable surgical technologies — that treat chronic pain as well as pain from spinal fractures, cancer and severe spasticity.
SPECIALTY THERAPIES offer a broad portfolio that addresses urologic and gastrointestinal disorders, conditions of the ear, nose and throat, as well as electrosurgical products for soft tissue dissection and hemostatic sealing of soft tissue and bone.
SPINE THERAPIES shape spine surgery for the better; delivering procedural solutions and therapeutic biologics and partnering with other healthcare stakeholders to accelerate innovations that can improve surgical efficiencies and help create better outcomes for more patients.
PAIN THERAPIES offer solutions — from early interventional procedures to implantable surgical technologies — that treat chronic pain as well as pain from spinal fractures, cancer and severe spasticity.
SPECIALTY THERAPIES offer a broad portfolio that addresses urologic and gastrointestinal disorders, conditions of the ear, nose and throat, as well as electrosurgical products for soft tissue dissection and hemostatic sealing of soft tissue and bone.
ABOUT MEDTRONIC:
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
EEO STATEMENT:
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees
DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
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