Sr. Quality Assurance Specialist

Summary of Position

In your role as Senior Quality Assurance Specialist you will work cross-functionally with Production Supply Chain Customer Support teams on a diverse medical product portfolio exploring exciting new fields such as in-vitro diagnostic devices mobile medical apps and Software as a Medical Device (SaMD). You will support Teladoc Health product design release and distribution while assuring compliance and quality excellence. Youll create work instructions guidance documents for quality operation review records pertaining to medical device production and subsequently release products to the market. In addition youll be responsible for a variety of related Quality Assurance duties as you contribute to Returned Device Inspection Document Changes and related activities.

Essential Duties and Responsibilities

Essential duties for the position including requirements tasks work to be complete

• Conduct Initial Functional Testing on returned medical device. Manage returned complaint investigation metrics. Escalate investigation results when the new failures are confirmed.

• Perform other testing and inspection activities as including product return analysis

• Review Device History Records (DHRs) assuring compliance with product specifications and company traceability requirements

• Verify that Teladoc Health medical devices are manufactured in accordance with the Device Master Record (DMR)

• Document and record results of all product review findings using appropriate data sheets and forms

• Support and coordinate product/process improvements through collaboration with cross-functional teams (Quality Manufacturing Product Tech Supply Chain etc.)

• Collaborate with appropriate technical clinical sales and/or returned product analysis employees to determine reporting eligibility

• Ensure compliance with the companys Quality Management System policies procedures and applicable external requirements/standards including FDA ISO13485 and other worldwide regulatory agencies

• Participate in continuous-improvement activities for the Quality Management System

• In cases of product non-conformity or design deviation ensure that these deviations have not negatively impacted product function and quality

• In cases of product non-conformity or design deviation ensure that deviations have full approval and are documented in the DHR

• Perform Product Release after completion of DHR reviews

• Review the DHR to support complaint investigations

• Maintain and update a status report for product returns pending device evaluations and investigations

• Assist in the analysis and trending of post-market surveillance data

• Support Document Change activities as needed

• Assist with other projects and duties as needed

Supervisory Responsibilities

No

Qualifications Expected for Position

Those qualification needed such as certification training experience or knowledge skills

• 5 years experience as a Quality Assurance professional

• Experience in a regulated product manufacturing environment

• Experience performing device history record (DHR) reviews (lot/batch record review) and component/product release activities

• A proven track record of meeting deadlines

• Proficiency with microscopes conventional handheld device inspection tools ( micrometers gage blocks etc.) and other related tools

• Demonstrated ability to effectively work cross-functionally with other departments including Operations and Product Development

• The ability to interface with both technical and non-technical personnel at all organizational levels

• Proficiency with Microsoft Office

• Speed and proficiency when learning new skills policies and corporate systems

• Demonstrated interpersonal written and oral communication skills

• The versatility to adapt to changing priorities and workflow for multiple projects and deadlines

• Demonstrated enthusiasm for working with a sense of urgency

• The ability to safely lift items weighing 20-50 pounds

• Prior experience with QA for medical devices preferred

• license or credential needed to perform job: N/A

  The above qualifications knowledge experience and/or background are expected but not for this role