Job Description
QARA ADMINISTRATIVE ASSISTANT – SAINT PAUL, MN
If you are looking for a career where you can grow and where your experience matters, MGC Diagnostics is for you. We provide a collaborative, fast-paced team environment that values each employee’s contributions. If this sounds like a fit for you, then we encourage you to apply for our “QARA Administrative Assistant” position in our Quality Assurance Department.
Since 1977, MGC DIAGNOSTICS (www.MGCDiagnostics.com) has been dedicated to being a leader in cardiorespiratory health solutions. Headquartered in Saint Paul, Minnesota, USA, MGC Diagnostics Corporation develops, manufactures, and markets non-invasive diagnostics systems for detecting, classifying, and managing cardiorespiratory disease.
Our success depends on the capabilities of our employees to help us achieve our business goals. We are passionate about developing powerful and accurate devices to assist in the diagnosis of respiratory disease and ensuring the information obtained benefits the disease management process. We are proud of our collaborative environment, where each individual’s contribution affects the company’s success. We are happy to provide meaningful careers where your efforts will benefit medical teams around the world.
PRIMARY PURPOSE This position is intended to address administrative tasks related to the Quality Assurance/ Regulatory Affairs (QARA) team and Quality Management System (QMS).
ORGANIZATIONAL RELATIONSHIPS
a) Reports to: Vice President, Global Engineering & QARA
b) Supervises: None
KEY RESPONSIBILITIES & ESSENTIAL FUNCTIONS
· Complaint Handling and Investigation Coordination
o Triage of inbound complaints and processing for QARA Functional Evaluators
o Completion of QARA Closed Case Review in SalesForce.com
o Logging and reporting on complaints for Post-Market Surveillance Activities
o Coordination and tracking of open (internal) investigations
· Corrective/ Preventative Action
o Coordination and document preparation for initiated CAPAs as well as task assignment to functional evaluators during noted stages, including VOE and Close-out.
· Non-Conforming Material Notifications
o Work with Quality Engineering to assign SIRs and SCARs to vendors.
· Training
o Coordination and execution of required QMS-related training for Company employees covered by QMS.
· Documentation Control (Back-up)
o Cross-train with Documentation Control to be qualified backup during PTO or illness.
· Reporting and Data Preparation
o Reporting and compilation of data for inclusion in Monthly Product Performance meetings, Quality Management Review, Risk Management, and Usability reporting.
· Audit Support
o Assist QARA leadership with the successful completion of audits/ inspections
· Accept other responsibilities as assigned.
· Complete training as identified by Standard Operating Procedures (SOP) and Procedural Work Instructions (PWI).
· Regular attendance per established schedule is an essential job function.
CONTACTS:
a) Internal: All Departments
b) External: Suppliers, customers, and regulatory bodies
JOB SPECIFICATIONS:
· High school diploma or equivalent education required
· Effective communication, both verbal and written
· Knowledge of Microsoft Windows, Office 365, and Adobe
WORKING CONDITIONS OR PHYSICAL REQUIREMENTS
Will be required to regularly sit for extended periods of time; use hands and fingers, handle or feel objects, talk, hear, and see. Occasionally lift and / or move up to 15 pounds, stand, walk, climb, balance, stoop, kneel, crouch, or reach with hands and arms. Environment is fast paced; time pressured and requires accuracy.
The normal work environment is remote and able to be chosen by the employee with manager approval. Regular remote, hybrid, or on-site attendance during normal business hours is expected, as agreed with the manager, and is an essential job function. Overtime may be required during peak periods. Remote location is expected to be commutable to the MGC facilities in case of on-site attendance.
EEO EMPLOYER:
MGC Diagnostics is an Equal Opportunity Employer. It is MGC Diagnostics’ policy to afford equal opportunity employment to all individuals without regard for race, color, creed, religion, national origin, sex, sexual orientation, gender identity or expression, disability, veteran status, age, familial status, marital status, genetic information, status regarding public assistance or any other characteristic protected under federal, state, or local laws. This policy applies to all phases of an individual's career, beginning with the initial recruitment and selection and continuing through the processes of placement, transfer, promotion, compensation, and benefits. MGC Diagnostics will act affirmatively in all matters of equal employment opportunity, including recruitment, hiring, and training of women, minority group individuals, Veterans, and individuals with disabilities to assure they are provided equal opportunity of employment. MGC Diagnostics is committed to providing accessibility to employment opportunities for people with disabilities.
Company Description
MGC Diagnostics Corporation (www.MGCDiagnostics.com) is a leader in providing innovative technology for cardiorespiratory diagnostics. We recognize that our success depends upon the capabilities of our employees to assist MGC Diagnostics in achieving its business goals. MGC Diagnostics is proud of its collaborative environment where it values contributions of each of its team members and rewards them accordingly. If you want a meaningful career where your efforts will benefit medical teams around the world and your qualifications match our requirements, please respond by emailing your resume and compensation requirements. The company offers a competitive compensation package and an attractive employee benefit plan including PTO, Holidays, Medical, Dental, Vision, Life, Short-Term and Long-Term Disability, and 401(k) match. EEO Employer MGC Diagnostics is an Equal Opportunity Employer. It is MGC Diagnostics policy to afford equal opportunity employment to all individuals without regard for race, color, creed, religion, national origin, sex, sexual orientation, gender identity or expression, disability, veteran status, age, familial status, marital status, genetic information, status with regard to public assistance or any other characteristic protected under federal, state or local laws. This policy applies to all phases of an individual's career, beginning with the initial recruitment and selection and continuing through the processes of placement, transfer, promotion, compensation and benefits. MGC Diagnostics will act affirmatively in all matters of equal employment opportunity, including recruitment, hiring and training of women, minority group individuals, Veterans and individuals with disabilities to assure they are provided equal opportunity of employment. MGC Diagnostics is committed to providing accessibility to employment opportunities for people with disabilities. As a Federal Contractor, MGC is in compliance with Affirmative Action in hiring and promoting veterans. Veterans are strongly encouraged to apply. If you need assistance with the application process, or have questions regarding priority referral for veterans, please contact Stephanie Montgomery, HR Manager at smontgomery@mgcdiagnostics.com or 651-766-3355. Our mailing address is 350 Oak Grove Pkwy, St. Paul MN 55127.