Quality Assurance Specialist I

Job Description:

DEXIS is looking for individuals who work their best, help others, and commit to helping us improve our customer lives and celebrate the difference in others.  

Who is DEXIS and why should you join the team?  

We are the leading manufacturer and distributor of innovative dental imaging equipment, software, and solutions. We offer meaningful work through innovation, diverse opportunities, and career progression.   

We also offer: 

• Competitive Pay and Bonuses.  
• PTO, Sick Time and Paid Holidays.  
• Tuition Reimbursement
• Competitive leave policies including but not limited to Sick, Jury Duty, Bereavement, Personal, and Parental Leave
• Medical, Dental, and Vision Insurance Benefits effective DAY ONE!!!!  
• 401K – with exceptional company match starting DAY ONE!!!!  
• Community involvement opportunities & employee appreciation events.  
• Newly renovated, state of the art, climate-controlled facility.  
• Newly built 1200 sq fitness room.
• Large outdoor patio area with gazebo.
• Gourmet coffee, beverages, snacks, and lunches are available in our café.  
• Employee Lounge with pool table, shuffleboard and skeet ball for downtime and employee fun!  

Where are we?  

Situated on the southern edge of the Lehigh Valley and easily accessible from northern Philadelphia suburbs and the surrounding areas, the Quakertown facility is our North American hub for the design and manufacturing of leading dental imaging devices and software.  The facility has a growing, energetic, and diverse mix of professionals spanning engineering, operations, regulatory and quality backgrounds that work collaboratively in the fast-paced medical device field.  A friendly and open atmosphere helps to foster strong personal and professional relationships across the organization.    

POSITION SUMMARY

This position will support the Quality, Regulatory, Operations, and Engineering departments by managing all open complaints, escalating Out of Box failures and suspected Adverse Events/MDR’s to the appropriate teams, and providing routine and ad hoc reports in support of reliability improvement projects and other Post Market Surveillance activities.

Essential Duties and Responsibilities:

• Review and evaluate new complaint notifications to ensure that the correct status was assigned, and information is complete and accurate.
• Coordinate with Technical Support team for any changes that may be required because of the evaluation and/or obtain additional information when needed.
• Filter notifications to escalate awareness and/or additional actions for Out of Box Failures and suspected Adverse Events/MDR’s.
• Manage complaints to ensure that they are closed within process timeframe.
• Continuously improve processes to further streamline and automate complaint data processing.
• Other duties as assigned.

Job Requirements:

Minimum Qualifications:

• High school diploma or equivalent plus 3 years of experience working in a quality assurance, medical device and/or manufacturing setting or Associate degree in relevant field such as engineering, science, math or operations.
• Must have basic computer skills, including proficiency in Microsoft Office software.

Preferred Qualifications: