Quality Engineer

Job Description

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 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

• Serve as the design quality engineer taking 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.