DEXIS Quality Assurance Manager

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 initiatives to drive to KPI targets.
• Conduct thorough investigations into reported complaints, collaborating with cross-functional teams to ensure complaint data accuracy, identify root causes, assess potential risks, and implement corrective and preventive actions (CAPAs).
• Maintain accurate and comprehensive records of all complaints, investigations, incident/event reportable, and resolutions, ensuring adherence to regulatory standards and internal procedures.
• Stay updated with relevant regulations and standards (e.g., FDA, ISO) and ensure that quality processes align with regulatory requirements.
• Collaborate with Tech Support, Customer Service, Engineering, Quality Assurance, and Regulatory Affairs teams to assess trends, identify areas for improvement, and contribute to the development of quality systems and processes.
• Prepare and present reports on complaint trends, investigation outcomes, and risk assessments to internal stakeholders and regulatory agencies as necessary.
• Maintain and drive improvements of the supplier quality management program.
• Oversee management of supplier files, including oversight and review of the Approved Suppliers List.
• Manage and support supplier audits.
• Manage and support the issuance and review of Supplier Corrective Action Requests, reviewing for accuracy and confirming effectiveness of the Corrective Action.
• Oversee the internal non-conforming parts/products process and the Material Review Board.
• Utilize established business tools (EBS) to drive continuous improvement of processes to further streamline and automate complaint data processing.
• Identify, initiate, and support product quality initiatives.
• Training of Quality Assurance Specialists and other team members.
• Other duties as assigned.

Job Requirements:

• Bachelor's degree; preferably in Engineering, Life Science, or similar technical field
• 5+ of experience in the medical device industry.
• 3+ direct supervisory and decision-making experience.
• Knowledge of FDA regulations, ISO 13485 MDSAP, EU MDR
• Proficient use of computers, MS-Office (Word, PowerPoint, and Excel knowledge required).
• Capable of communicating with clarity within team, cross-functional departments, and management.
• Capable of making decisions for day-to-day activities.
• Demonstrated ability to teach and mentor.
• Ability to analyze and assimilate data including engineering drawings, specifications, labeling, statutory and regulatory requirements.
• Self-motivated and able to work with minimum supervision.

PREFERRED QUALIFICATIONS:

• Experience with FDA regulations, ISO 13485 MDSAP, EU MDR
• Strong knowledge of complaint processes and adverse event reporting.
• Excellent analytical skills with the ability to conduct thorough investigations and root cause analyses.
• SAP ERP and document control experience.
• Experience with Microsoft Dynamics CRM.
• Knowledge of GMP and Quality Systems in a regulated industry (medical device or pharmaceutical area).
• Exceptional organizational skills and attention to detail to maintain accurate documentation and records.
• Effective interpersonal and communication skills with the ability to collaborate cross-functionally, interact with customers professionally and empathetically, and work with minimum supervision.
• Certification in quality management (e.g., Certified Quality Auditor - CQA) is a plus.

Physical Requirements:  General office environment, sitting, standing, and working on a computer.

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Target Market Salary Range:

Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled.  At Envista, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans.

Operating Company:

Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/ compliance/posters/pdf/eeopost.pdf.

Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate.  Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes.  An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening.  Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.