Quality Engineer – Medical Devices (Hybrid/Remote Options)

Convergent Dental Inc.; Waltham (MA); Hybrid; USD 90,000 - 110,000; Full time

Benefits offered by this job

Flexible work from home options

Opportunity for career growth

Job summary

Convergent Dental Inc. is looking for a Quality Engineer to ensure compliance with quality and regulatory standards. This role involves collaborating across teams to implement quality management processes and lead design control activities.

The ideal candidate should have a Bachelor's degree in Engineering and at least 5 years of experience in the medical device industry. The position allows for hybrid work arrangements.

Qualifications

• 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 with software as a medical device (SaMD) preferred.

Responsibilities

• Serve as the quality representative on design and development projects.
• Ensure compliance with applicable standards and regulations.
• Lead and support design control activities.

Skills

Strong knowledge of FDA QMSR, ISO 13485, ISO 14971, and EU MDR requirements

Demonstrated problem-solving skills

Ability to analyze complex situations

Strong verbal and written communication skills

Skilled in risk management techniques

Education

Bachelor’s degree in Engineering or related technical discipline

Minimum 5 years of experience in Quality Engineering within a regulated industry

Job description

Convergent Dental Inc. is looking for a Quality Engineer to ensure compliance with quality and regulatory standards. This role involves collaborating across teams to implement quality management processes and lead design control activities.

The ideal candidate should have a Bachelor's degree in Engineering and at least 5 years of experience in the medical device industry. The position allows for hybrid work arrangements.