Quality Engineer

Convergent Dental

Waltham, Massachusetts

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JOB DETAILS

SKILLS

Adverse Events, Analysis Skills, Anesthesiology, Biomedical Engineering, Code of Federal Regulations, Communication Skills, Continuous Improvement, Contract Manufacturing, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Dental Technology, Dentistry, Detail Oriented, Documentation, Engineering Change Order, Engineering Drawing, External Audit, FDA (Food and Drug Administration), ISO (International Organization for Standardization), Insurance Regulations, Internal Audit, Laser Science, Maintain Compliance, Manufacturing Requirements, Market Analysis, Market Trend Analysis, Medical Equipment, Organizational Skills, Presentation/Verbal Skills, Process Improvement, Product Design, Product Development, Product Engineering, Product Lifecycle, Quality Assurance, Quality Engineering, Quality Management, Quality Metrics, Quality Monitoring, Recruiting/Staffing Agency, Regulations, Regulatory Compliance, Research & Development (R&D), Risk Management, Root Cause Analysis, Social Media, Statistics, Surveillance, Technical Writing, Test Strategy, Testing, Trend Analysis, Validation Testing, Writing Skills, eCos

LOCATION

Waltham, Massachusetts

POSTED

30+ days ago

POSITION 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 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.

Location: position while hybrid will be at our Waltham, MA 02451 headquarters.
Local candidates only will be considered.
VISA sponsorship not available.

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.
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.
Participate in post-market surveillance activities, including complaint handling, adverse event reporting, and product recalls.
Analyze post-market data and trends to identify opportunities for product and process improvements.

Key Skills/Abilities

Strong knowledge of FDA QMSR, ISO 13485, ISO 14971, and EU MDR requirements.
Demonstrated problem solving skills and the ability to analyze complex situations and make sound decisions.
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.

Education/Experience

Bachelor’s degree in Engineering, Biomedical Engineering, or related technical discipline.
Minimum 5 years of experience in Quality Engineering within the medical device industry.
Experience in quality assurance or regulatory affairs within a regulated industry (e.g., FDA-regulated medical device) preferred.
Experience working in a smaller, more agile environment is a strong plus.
Experience working with contract manufacturers and suppliers.
Experience with software as a medical device (SaMD) or digital health technologies preferred.

Employment Type: Full-Time
Reports To: Director of Quality and Regulatory

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. If you are a motivated, career-oriented individual who is interested in this significant opportunity, 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.

Disclaimer for Recruitment Agencies
Convergent Dental, Inc. does not accept unsolicited resumes from recruiters or employment agencies nor are we looking to add any search firms 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.

Flexible work from home options available.

Compensation: $90,000.00 - $135,000.00 per year

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.

Quality Engineer

Convergent Dental

Waltham, Massachusetts

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.

About the Company

Convergent Dental

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