Envista
Quality Assurance Supervisor
Envista, Jackson, Mississippi, United States,
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 ReimbursementCompetitive 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.POSITION SUMMARYThe
Quality Assurance Supervisor
is responsible for leading the Complaint Handling/Post-Market Surveillance (PMS) team to provide post-market data for product and process improvement initiatives utilizing EBS tools (CDT&R, PSP, DM/VM, SW). The role is accountable for the screening and reporting of adverse events to the relevant regulatory authorities and providing the same data for PMS reports in relation to the requirements of EU MDR. This includes, but is not limited to, complaint review and evaluation, out of box failures evaluations, and suspected Adverse events/MDR’s evaluations and reporting by ensuring compliance with regulatory standards, conducting in-depth investigations, assisting with submitting reportable incidents/events to applicable global regulatory agencies, implementing corrective and preventive actions, and maintaining meticulous records. Additionally, you will collaborate with cross-functional teams to analyze complaint trends, identify root causes, drive improvements in our quality systems, and support product quality initiatives. This role is on site full time.Essential Duties and 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.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).Manage all adverse event review, investigation, determination of reportability, and reporting to Competent Authorities.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 complaint handling 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.Ensure complaint reviews and closures are completed within established timeframe.Filter notifications to escalate awareness and/or additional actions for Out of Box Failures and suspected Adverse Events/MDR’s.Obtain Device History Records as required to support investigations.Prepare and publish routine and ad hoc external defect reports by product family.Create Pareto charts and assist in data analyses for root cause investigations for reliability improvement projects, Verifications of Effectiveness, and similar activities.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.Other duties as assigned.Job Requirements:Minimum Qualifications:Bachelor's degree; preferably in Engineering, Life Science, or similar technical fieldFive or more years of experience in the Medical Device industry.At least two years of decision-making experience.One or more years of direct supervisory experienceSuperior written, verbal, interpersonal communications; presentation skills are a huge plusProficient use of computers, MS-Office (Word, PowerPoint, and Excel knowledge required)Ability to analyze and assimilate data including engineering drawings, specifications, labeling, statutory and regulatory requirements.Experience with Problem-Solving Process (PSP); experience handling customer complaints highly preferredSelf-motivated and able to work with minimum supervision.Preferred Qualifications: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.Target Market Salary Range:$72,900 - $109,300Operating Company:
DEXISEnvista 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.
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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 ReimbursementCompetitive 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.POSITION SUMMARYThe
Quality Assurance Supervisor
is responsible for leading the Complaint Handling/Post-Market Surveillance (PMS) team to provide post-market data for product and process improvement initiatives utilizing EBS tools (CDT&R, PSP, DM/VM, SW). The role is accountable for the screening and reporting of adverse events to the relevant regulatory authorities and providing the same data for PMS reports in relation to the requirements of EU MDR. This includes, but is not limited to, complaint review and evaluation, out of box failures evaluations, and suspected Adverse events/MDR’s evaluations and reporting by ensuring compliance with regulatory standards, conducting in-depth investigations, assisting with submitting reportable incidents/events to applicable global regulatory agencies, implementing corrective and preventive actions, and maintaining meticulous records. Additionally, you will collaborate with cross-functional teams to analyze complaint trends, identify root causes, drive improvements in our quality systems, and support product quality initiatives. This role is on site full time.Essential Duties and 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.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).Manage all adverse event review, investigation, determination of reportability, and reporting to Competent Authorities.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 complaint handling 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.Ensure complaint reviews and closures are completed within established timeframe.Filter notifications to escalate awareness and/or additional actions for Out of Box Failures and suspected Adverse Events/MDR’s.Obtain Device History Records as required to support investigations.Prepare and publish routine and ad hoc external defect reports by product family.Create Pareto charts and assist in data analyses for root cause investigations for reliability improvement projects, Verifications of Effectiveness, and similar activities.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.Other duties as assigned.Job Requirements:Minimum Qualifications:Bachelor's degree; preferably in Engineering, Life Science, or similar technical fieldFive or more years of experience in the Medical Device industry.At least two years of decision-making experience.One or more years of direct supervisory experienceSuperior written, verbal, interpersonal communications; presentation skills are a huge plusProficient use of computers, MS-Office (Word, PowerPoint, and Excel knowledge required)Ability to analyze and assimilate data including engineering drawings, specifications, labeling, statutory and regulatory requirements.Experience with Problem-Solving Process (PSP); experience handling customer complaints highly preferredSelf-motivated and able to work with minimum supervision.Preferred Qualifications: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.Target Market Salary Range:$72,900 - $109,300Operating Company:
DEXISEnvista 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.
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