Quality Engineer

Job DescriptionJob DescriptionPOSITION SUMMARY
We’re 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 design quality and development lifecycle , supporting cross-functional teams, and helping to shape our robust Quality Management System (QMS) to meet our business requirements.
Key Responsibilities n

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• Serve as the design quality engineer taking development projects from concept through commercialization. 
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• Ensure compliance with applicable standards and regulations, including ISO 13485, FDA 21 CFR Part 820, and EU MDR.
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• Lead and support design control activities: risk management (ISO 14971), design inputs/outputs, verification and validation, design reviews, and design history file (DHF) maintenance.
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• Develop and implement quality plans, test strategies, and protocols for new product development.
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• Drive root cause analysis and corrective/preventive actions (CAPA) related to product design and development. 
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• Monitor and analyze quality metrics and trends. Support development and continuous improvement of the Quality Management System.
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• Participate in technical design reviews and project phase reviews. 
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• Review and approve Engineering Change Orders (ECOs), test protocols, and technical documentation.
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• Collaborate with Product Management, Engineering, R&D, Regulatory, Manufacturing, Customer Success and Clinical teams to ensure quality is integrated throughout the product lifecycle.
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• Support internal, external audits and regulatory inspections.
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• Provide Quality representation during problem resolution supporting a risk-based approach for processes. 
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• Establish and maintain metrics and reports for design quality performance.
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Key Skills/Abilities n

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• Strong knowledge of FDA QSR, ISO 13485, ISO 14971, and EU MDR.
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• Demonstrated ability to interpret engineering drawings, specifications, and technical documents.
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• Strong verbal and written communication skills, ability to present issues, plans, and objectives
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• Strong documentation, analytical, and organizational skills
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• Skilled in risk management techniques, root cause analysis, and statistical tools.
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• Excellent communication and organizational skills with the ability to work independently and cross-functionally.
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• Certified Quality Engineer (CQE) or other relevant certifications such as Six Sigma .
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Education/Experience n

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• Bachelor’s degree in Engineering, Biomedical Engineering, or related technical discipline.
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• Minimum 5 years of experience in Quality Engineering within the medical device industry.
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• Experience working in a smaller, more agile environment is a strong plus.
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• Experience working with contract manufacturers and suppliers.
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• Experience with tools such as FMEA, CAPA, Root Cause Analysis (5 Whys, Fishbone), and control charts.
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• Experience with software as a medical device (SaMD) or digital health technologies . 
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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 , 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. Solea’s 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.