Job description

Roles & Responsibilities:

• Help alleviate roadblocks with Quality Assurance team by working with cross functional teams
• Work closely with Global Distribution Compliance Manager, IT department, Distributors to track tasks and deadlines and to keep them accountable, as well as, internal cross functional team members for scorecard deadlines.
• Facilitate communication with cross-functional teams and send routine correspondence by presenting and sharing regular updates.
• Maintain /update Trackwise, project trackers etc., assuring that they are current and accurate
• Work with IT to create Data needed for QRB for Distributor CAPAs
• Help manage and send out surveys to distributors and track results
• Ability to work within a team and as an individual contributor in a fast- paced changing environment.

o Ability to leverage and engage others to accomplish projects within the QA team

• Initiate Electronic Change Order (ECO) for Distributor Control procedures in Agile
• Respond to other department requests as needed

Skills, Experience, Education, & Training:

• Education:

o B.S. degree or higher or equivalent experience
o Experience: 2-3 years relevant experience working in a medical device company
o Experience with regulatory audits and compliance
o Foundation understanding of MDR regulations and IS0 13485 from a QMS standpoint

• Skills:

o 1-2 years audit experience preferred
o Strong organizational and follow up skills with attention to detail
o Be able to solve complex problems within the area of responsibility for Indirect QA team that requires ingenuity and creativity
o Good communication (written and oral) and organizational skills
o Ability to perform multiple tasks in a fast-paced environment
o Ability to prioritize and meet deadlines in a timely manner
o Motivated to excel and work in a team environment
o Excellent interpersonal skills
o Ability to deal with problems/issues in a professional manner
o Understand implications of work and make recommendations for improvements in processes
o Excellent skills in MS Word, PowerPoint, Visio, Smart Sheet, Excel, and Outlook; capacity to learn additional software

Job Types: Full-time, Contract

Salary: $40.00 - $45.00 per hour

Benefits:

• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Experience:

• FDA regulations: 1 year (Preferred)
• regulatory audits and compliance: 3 years (Preferred)

Work Location: Remote

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