QA Compliance Specialist – Med Device (On-Site)

Anika; Bedford (MA); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Discretionary bonus

Healthcare benefits

Health Savings Account

401(k) plan with company match

Employee stock purchase plan

Paid time off

Job summary

Anika is seeking a QA Compliance Specialist to help ensure regulatory and documentation requirements are met in a regulated medical device environment. You will review production records, support shop-floor quality activities, and assist with audits to maintain cGMP and ISO 13485 compliance.

The role is based at Anika’s Bedford, MA facility and is fully on-site, offering opportunities to partner with Production and Quality Assurance on investigations, CAPAs, and product release activities.

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• 0–2 years of industry experience; internship acceptable.
• Strong written and verbal communication skills.
• Good organizational skills and attention to detail.

Responsibilities

• Review production records and COAs for accuracy prior to release.
• Support audits and quality investigations.
• Maintain Device History Records and quality documentation.
• Assist with change controls, CAPAs, and nonconformances.

Skills

Attention to detail

Documentation

Cross-functional teamwork

Excellent communication

Education

Bachelor's degree in Life Sciences

Tools

MS Office

Databases

Job description

Anika is seeking a QA Compliance Specialist to help ensure regulatory and documentation requirements are met in a regulated medical device environment. You will review production records, support shop-floor quality activities, and assist with audits to maintain cGMP and ISO 13485 compliance.

The role is based at Anika’s Bedford, MA facility and is fully on-site, offering opportunities to partner with Production and Quality Assurance on investigations, CAPAs, and product release activities.