Convergent Dental
Quality Analyst
Convergent Dental, Waltham, Massachusetts, United States, 02254
Position Summary:The Quality Analyst supports Quality System elements at Convergent Dental including Document and Records Control, Training, Non-Conformance & CAPA, Management Controls, Complaints, Audits, and Supplier Management. This position interacts with key functions including Quality, R&D, Regulatory, Manufacturing, Marketing, Customer Success, IT, and Field Service. We are looking for a hands-on, highly motivated, driven individual that can also work independently. The candidate will thrive in a fast-paced environment that rewards bright, self-starting, energetic, focused individuals seeking increasing responsibility and challenge. This position will report to the Director of QA/RA.Primary Responsibilities:
Owns Doc Control process by supporting change orders, document creation, revision & release.Manages electronic Documentation Management System (eDMS) by creating workflows, troubleshooting, creating templates, user training & support.Creates, controls, and maintains training documents and document files.Supports and conducts New Employee training and provides training support, as applicable.Collects training records, checks for accuracy, completeness, and obtains corrections when necessary.Reviews various documentation for completeness and accuracy. This includes manufacturing assembly, data calculation and log entries, supplier documents and test documents.Performs product release activities including review of DHRs and post-production documents.Coordinates and conducts technical investigation and documentation of non-conforming events and corrective/preventative action.Completes trend analysis and capture metrics for reports including Complaints, Management Review, MRB & Non-Conforming Records, and CAPA Records.Reviews Quality and Operations key performance indicators and supports the compliance effort of the Quality team.Develops and implements quality data reporting and analysis to support the overall Quality Management System.Provides critical information for audits and reviews/analyzes data and documentation.Identifies and addresses any potential quality impact.Education and Experience:
Knowledge of FDA Quality System Regulation, cGMP and ISO 13485: 2016, as they pertain to the medical device industry.Bachelor’s degree (B.S.) or equivalent in related field.2-3 years related experience in an FDA QSR, cGMP, ISO 13485 compliant environment.Prior medical device experience, highly desirable.Experience with MasterControl & Arena strongly preferred.Experience in a manufacturing facility preferred.Detail-oriented, possess excellent verbal and written communication skills, good interpersonal and organizational skills and be a team player.Proven problem-solving skills.Must be able to interpret a variety of technical instructions.Advanced skills in Word, Excel and other MS Office applications.Ability to partner effectively throughout the organization to maintain compliance and foster a quality mindset.Position Location:
Our Corporate Office is located in Waltham, MA 02451. The Quality Analyst position will be onsite (4-5 days in the office).About Convergent Dental:
Convergent Dental is a high-energy, high-tech, dental systems company that is experiencing rapid growth and looking for new team members who can grow with us. Our environment is fast paced and entrepreneurial. We seek someone who will thrive in a highly autonomous environment and is willing to roll up their sleeves to get the job done.The Company has entered the market with Solea, the first-of-its-kind CO2 hard and soft tissue laser that cuts faster than any other laser-based system in dentistry. Solea’s speed and precision is a result of its wavelength and computer controls that are unique to Convergent Dental. If you are a motivated, career-oriented individual who is interested in being in on the early stage of a significant opportunity, Convergent Dental is the place for you.Job Type:
Full-timeSchedule:
Monday to FridayConvergent Dental is committed to developing a diverse and talented team. All candidates that meet the job requirements are encouraged to apply. If you are unsure whether you meet 100% of the requirements, we encourage you to inquire and/or apply.Convergent Dental is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state or local protected class.Disclaimer for Recruitment Agencies:
Convergent Dental, Inc. does not accept unsolicited resumes from recruiters or employment agencies in response to our Careers page or any job posting or social media post. Convergent Dental, Inc. will not consider or agree to payment of any referral compensation or recruiter fee relating to these unsolicited resumes. Convergent Dental, Inc. explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes received, including those submitted to hiring managers, are deemed to be the property of Convergent Dental, Inc. Additionally, we are not evaluating recruitment services at this time.
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Owns Doc Control process by supporting change orders, document creation, revision & release.Manages electronic Documentation Management System (eDMS) by creating workflows, troubleshooting, creating templates, user training & support.Creates, controls, and maintains training documents and document files.Supports and conducts New Employee training and provides training support, as applicable.Collects training records, checks for accuracy, completeness, and obtains corrections when necessary.Reviews various documentation for completeness and accuracy. This includes manufacturing assembly, data calculation and log entries, supplier documents and test documents.Performs product release activities including review of DHRs and post-production documents.Coordinates and conducts technical investigation and documentation of non-conforming events and corrective/preventative action.Completes trend analysis and capture metrics for reports including Complaints, Management Review, MRB & Non-Conforming Records, and CAPA Records.Reviews Quality and Operations key performance indicators and supports the compliance effort of the Quality team.Develops and implements quality data reporting and analysis to support the overall Quality Management System.Provides critical information for audits and reviews/analyzes data and documentation.Identifies and addresses any potential quality impact.Education and Experience:
Knowledge of FDA Quality System Regulation, cGMP and ISO 13485: 2016, as they pertain to the medical device industry.Bachelor’s degree (B.S.) or equivalent in related field.2-3 years related experience in an FDA QSR, cGMP, ISO 13485 compliant environment.Prior medical device experience, highly desirable.Experience with MasterControl & Arena strongly preferred.Experience in a manufacturing facility preferred.Detail-oriented, possess excellent verbal and written communication skills, good interpersonal and organizational skills and be a team player.Proven problem-solving skills.Must be able to interpret a variety of technical instructions.Advanced skills in Word, Excel and other MS Office applications.Ability to partner effectively throughout the organization to maintain compliance and foster a quality mindset.Position Location:
Our Corporate Office is located in Waltham, MA 02451. The Quality Analyst position will be onsite (4-5 days in the office).About Convergent Dental:
Convergent Dental is a high-energy, high-tech, dental systems company that is experiencing rapid growth and looking for new team members who can grow with us. Our environment is fast paced and entrepreneurial. We seek someone who will thrive in a highly autonomous environment and is willing to roll up their sleeves to get the job done.The Company has entered the market with Solea, the first-of-its-kind CO2 hard and soft tissue laser that cuts faster than any other laser-based system in dentistry. Solea’s speed and precision is a result of its wavelength and computer controls that are unique to Convergent Dental. If you are a motivated, career-oriented individual who is interested in being in on the early stage of a significant opportunity, Convergent Dental is the place for you.Job Type:
Full-timeSchedule:
Monday to FridayConvergent Dental is committed to developing a diverse and talented team. All candidates that meet the job requirements are encouraged to apply. If you are unsure whether you meet 100% of the requirements, we encourage you to inquire and/or apply.Convergent Dental is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state or local protected class.Disclaimer for Recruitment Agencies:
Convergent Dental, Inc. does not accept unsolicited resumes from recruiters or employment agencies in response to our Careers page or any job posting or social media post. Convergent Dental, Inc. will not consider or agree to payment of any referral compensation or recruiter fee relating to these unsolicited resumes. Convergent Dental, Inc. explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes received, including those submitted to hiring managers, are deemed to be the property of Convergent Dental, Inc. Additionally, we are not evaluating recruitment services at this time.
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