Quality Systems Engineer - Drive QMS Excellence & CAPA

VulcanForms; Harvard (MA); On-site; USD 75,413 - 103,692; Full time

Benefits offered by this job

Comprehensive medical, dental, vision, and life insurance

Generous paid time off

401(k) plan with company match

Job summary

VulcanForms, located in Harvard, MA, is looking for a Quality Systems Engineer to ensure compliance with quality management system regulations. The role involves writing and updating QMS procedures, supporting NCR and CAPA programs, and working with cross-functional teams to enhance quality metrics.

The position requires over 3 years' experience in medical device or aerospace fields, excellent communication skills, and knowledge of regulatory requirements. The annual base salary ranges from $75,413 to $103,692, with comprehensive benefits offered.

Qualifications

• 3+ years' experience in the medical device or aerospace fields.
• Proficiency in FDA regulatory requirements, ISO 13485, or AS9100/ISO9001.
• Experience writing QMS procedures and working with quality metrics.

Responsibilities

• Establish and maintain a quality system in accordance with regulatory requirements.
• Write, review, and approve changes to QMS documentation.
• Support NCR and CAPA programs and conduct audits as needed.

Skills

Experience in FDA regulatory requirements

Experience writing QMS procedures

Experience with NCR and CAPA

Excellent communication skills

Experience evaluating Quality metrics

Job description

VulcanForms, located in Harvard, MA, is looking for a Quality Systems Engineer to ensure compliance with quality management system regulations. The role involves writing and updating QMS procedures, supporting NCR and CAPA programs, and working with cross-functional teams to enhance quality metrics.

The position requires over 3 years' experience in medical device or aerospace fields, excellent communication skills, and knowledge of regulatory requirements. The annual base salary ranges from $75,413 to $103,692, with comprehensive benefits offered.