Job Information
Volt QUA Technician in Little Canada, Minnesota
Volt is immediately hiring a Post Market Surveillance Assistant in Maplewood, MN with a well-known industry leader for their new medical device company. This is a first shift, full-time contingent opportunity. As a Post Market Surveillance Assistant, you will:
- Enjoy Working with PMS Analysts to draft PMS plans and reports, upload to database, route for review/approval.
- Attend cross-functional PMS team meetings and tracks open items to ensure timely issue closure.
- Works with local and long-distance product teams to develop/ maintain PMS requirements (PMS Plans, PMS reports, Periodic Safety Update Reports)
- Ensures compliance to PMS schedules and creates / maintains metric reports on the PMS system for review.
Estimated Duration up to 24 months. The ideal candidate will have:
- Bachelor's degree with 1 - 2 years' work experience preferably in a regulated field environment.
- Proficiency with Microsoft Office applications including Word, Excel, Access, PowerPoint, Project and Outlook including charting and pivot tables.
- Experience collaborating with local and long-distance project teams to drive key initiatives or processes in a global, matrixed organization.
Preferred Position Requirements:
- Experience with regulated medical environments such as medical devices, pharmaceuticals, or biologics, including GMPs and Medical Device Directive.
- Experience with analyses of data such as product complaints, clinical studies, and competitive products.
- Experience with FDA and MDD/MDR requirements concerning medical devices.
- Experience in creating, reviewing, and approving in a quality management system.
- Experience with statistical sampling requirements related to component/process critical and application of risk management.
- Demonstrated success in project management, teamwork and influencing others to achieve results (i.e. Six Sigma / PMP certification).
- Demonstrated presentation and communication skills.
- Demonstrated understanding of the application of Corrective and Preventive Action.
Pay Rate: $23.36 per hour *Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc. Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible. Benefits: Volt offers benefits (based on eligibility) that include the following: health, dental, vision, term life, short term disability, AD&D, 401(k), Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP). Volt is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Volt is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please email hr_dept@volt.com or call (866) 898-0005. Please indicate the specifics of the assistance needed. Volt does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance I itiative for Hiring Ordinance, and other applicable laws. Job ID : 432555