QA Specialist, Deviations
The Role
As much as COVID-19 has changed the landscape of the world as we knew it, we've finally begun to return to a form of normalcy. For the most part, the gateway to an international flight or a visit to grandchildren is simply a negative COVID test. But if those tests are unreliable and the results can't be trusted, lives are put on hold - or worse, in danger.
As a QA Specialist at one of the most renowned healthcare organizations in the world, you'll field complaints regarding at-home COVID tests - rather than answering phones, you'll be directly addressing customer concerns taken from their calls and opening investigations accordingly. You're the first line of defense against repeat issues and your contributions will ensure that every outgoing batch of tests is more dependable than the last!
Daily Responsibilities
Post Market Activities:
- Managing the site Customer Complaint Investigation Program, including responsibility for deciding which complaints will be investigated, how they will be investigated, coordinating data generating activities, evaluating data and writing investigation summaries/conclusions.
- Maintaining effective communication with Technical Service groups (worldwide locations) regarding this site's product complaint investigations
- Post Market Surveillance; responsibility for assisting with this program.
- Identify events that may be subject to vigilance reporting requirements and communicate to Regulatory for evaluation.
- Other duties as assigned.
Qualifications
Required:
- Bachelor's Degree in Biology, Chemistry Life Sciences, and or other related technical field or the equivalent education and experience.
- 1+ years of experience in a Technical Service role
Preferred:
- Clinical Microbiologist experience
- 1+ years of experience in a Technical Service role in the medical device industry
- Prior experience with SalesForce
- Demonstrated ability to manage complex programs, and multiple priorities in a timely manner.
- Demonstrated ability to analyze data and draw appropriate conclusions.
- Strong communication skills including accurate technical writing.
- Proficiency in Database software; Internet software; and Word Processing software.
- Proficiency in Spreadsheet software.
- Demonstrated understanding of lab practices.
- Good working knowledge of medical terminology.
Daily Duties
- Training and career development, with onboarding programs for new employees and tuition assistance
- Financial security through competitive compensation, incentives and retirement plans
- Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
- Paid time off
- 401(k) retirement savings with a generous company match
- The stability of a company with a record of strong financial performance and history of being actively involved in local communities