Quality Engineer
Quality Engineer
Posted on :
10-06-2025
Employer Active
1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
10-06-2025
Job Description
POSITION SUMMARY
Were seeking a proactive and detail-oriented Quality Engineer to ensure that our product development processes meet quality regulatory and company standards. You will play a pivotal role in embedding quality into the design and development lifecycle supporting cross-functional teams and helping to shape our robust Quality Management System (QMS) to meet our business requirements.
Key Responsibilities
Were seeking a proactive and detail-oriented Quality Engineer to ensure that our product development processes meet quality regulatory and company standards. You will play a pivotal role in embedding quality into the design and development lifecycle supporting cross-functional teams and helping to shape our robust Quality Management System (QMS) to meet our business requirements.
Key Responsibilities
- Serve as the quality representative on design and development projects from concept through commercialization.
- Ensure compliance with applicable standards and regulations including ISO 13485 FDA 21 CFR Part 820 and EU MDR.
- Lead and support design control activities: risk management (ISO 14971) design inputs/outputs verification and validation design reviews and design history file (DHF) maintenance.
- Develop and implement quality plans test strategies and protocols for new product development.
- Drive root cause analysis and corrective/preventive actions (CAPA) related to product design and development. Monitor and analyze quality metrics and trends. Support development and continuous improvement of the Quality Management System.
- Participate in technical design reviews and project phase reviews.
- Review and approve Engineering Change Orders (ECOs) test protocols and technical documentation.
- Collaborate with Product Management Engineering R&D Regulatory Manufacturing Customer Success and Clinical teams to ensure quality is integrated throughout the product lifecycle.
- Support internal external audits and regulatory inspections.
- Provide Quality representation during problem resolution supporting a risk-based approach for processes.
- Establish and maintain metrics and reports for design quality performance.
Key Skills/Abilities
- Strong knowledge of FDA QSR ISO 13485 ISO 14971 and EU MDR.
- Demonstrated ability to interpret engineering drawings specifications and technical documents.
- Strong verbal and written communication skills ability to present issues plans and objectives
- Strong documentation analytical and organizational skills
- Skilled in risk management techniques root cause analysis and statistical tools.
- Excellent communication and organizational skills with the ability to work independently and cross-functionally.
- Certified Quality Engineer (CQE) or other relevant certifications such as Six Sigma preferred.
Education/Experience
- Bachelors degree in Engineering Biomedical Engineering or related technical discipline.
- Minimum 5 years of experience in Quality Engineering within the medical device industry.
- Experience working in a smaller more agile environment is a strong plus.
- Experience working with contract manufacturers and suppliers.
- Experience with tools such as FMEA CAPA Root Cause Analysis (5 Whys Fishbone) and control charts.
- Experience with software as a medical device (SaMD) or digital health technologies preferred.
Location: Waltham MA 02451 4-5 days onsite required
Employment Type: Full-Time
Reports To: Director of Quality and Regulatory
We offer competitive salary and benefits!
401(k) plans & matching Health Dental & Vision Insurance Short & Long Term Disability Parental Leave Life Insurance Stock Options EAP & voluntary benefits.
ABOUT CONVERGENT DENTAL:
Convergent Dental Inc. is a privately owned dental equipment and technology company. Our high-energy high-tech culture is experiencing rapid growth and looking for new team members who can grow with us. Our flagship product Solea is the only CO2 laser to be cleared by the FDA for all-tissue indications and delivers an anesthesia-free blood-free suture-free experience.
Solea is a true breakthrough in dental laser technology that offers a completely different experience for both dentists and patients when compared to traditional instruments or any earlier laser treatment. Soleas speed and precision is a result of its wavelength and computer controls that are unique to Convergent Dental Inc.
We are a high-energy team and looking for new members who can grow with us. Our culture is fast paced collaborative and a roll up your sleeves entrepreneurial environment. We are all working towards forever changing how people think about going to the dentist. If you are a motivated career-oriented individual Convergent Dental is the place for you!
Convergent Dental is committed to developing a diverse and talented team. All candidates are encouraged to apply. If you are excited about this role but are unsure whether you meet 100% of the requirements we encourage you to inquire and/or apply.
Employment Type: Full-Time
Reports To: Director of Quality and Regulatory
We offer competitive salary and benefits!
401(k) plans & matching Health Dental & Vision Insurance Short & Long Term Disability Parental Leave Life Insurance Stock Options EAP & voluntary benefits.
ABOUT CONVERGENT DENTAL:
Convergent Dental Inc. is a privately owned dental equipment and technology company. Our high-energy high-tech culture is experiencing rapid growth and looking for new team members who can grow with us. Our flagship product Solea is the only CO2 laser to be cleared by the FDA for all-tissue indications and delivers an anesthesia-free blood-free suture-free experience.
Solea is a true breakthrough in dental laser technology that offers a completely different experience for both dentists and patients when compared to traditional instruments or any earlier laser treatment. Soleas speed and precision is a result of its wavelength and computer controls that are unique to Convergent Dental Inc.
We are a high-energy team and looking for new members who can grow with us. Our culture is fast paced collaborative and a roll up your sleeves entrepreneurial environment. We are all working towards forever changing how people think about going to the dentist. If you are a motivated career-oriented individual Convergent Dental is the place for you!
Convergent Dental is committed to developing a diverse and talented team. All candidates are encouraged to apply. If you are excited about this role but are unsure whether you meet 100% of the requirements we encourage you to inquire and/or apply.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race color religion sex national origin disability status protected veteran status or any other characteristic protected by law.
Employment Type
Full-Time
Key Skills
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