DEXIS Quality Assurance Manager (ON-SITE Quakertown, PA)

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!  
• EVC Charges for Electric/Hybrid cars

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.    

JOB SUMMARY:

The Quality Assurance Manager (QA Manager) is responsible for leading the Quality Engineering and Complaint Handling/Post-Market Surveillance (PMS) teams. They are responsible for executing quality strategies for sustaining and new products, as well as supervising and coaching the work of staff in this area. The QA Manager oversees post-market data for product and process improvement initiatives utilizing EBS tools (CDT&R, PSP, DM/VM, SW). The role is accountable for KPI reporting and driving KPIs to targets. The QA Manager is responsible for supplier quality management, validation program, investigation of product and process defects, including non-conforming parts and products, complaints, and identifies any additional risks or controls. The QA Manager also supports the internal audit program and participates in external audits from the corporate audit team and regulatory authorities. Additionally, you will collaborate with cross-functional and international teams to analyze complaint trends, identify root causes, drive improvements in our quality systems, and support product quality initiatives.

PRIMARY DUTIES & RESPONSIBILITIES:

• Overseeing end-to-end process of receiving, reviewing, documenting, investigating, and resolving complaints related to our medical devices in compliance with regulatory requirements and within process timeframes.
• Analyzing and reporting of KPIs related to supplier and product quality and overseeing initia