Job Description
Job DescriptionPOSITION 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
- 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.
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.
Location: Waltham, MA 02451, 4-5 days onsite required
Employment Type: Full-Time
Reports To: Director of Quality and Regulatory
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.