ISO 13485 QA/RA Specialist — Quality & Compliance

MMQCI-Maine Molecular Quality Controls Inc.; Saco (ME); On-site; USD 39,000 - 74,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) retirement savings plan

Company profit sharing program

Paid time off including vacation, plus

Job summary

MMQCI, a Southern Maine diagnostics company, is seeking a QA/RA Specialist to support quality assurance activities and regulatory compliance within an ISO 13485 environment. Reporting to the QA/RA Manager, you will maintain policies and procedures that keep MMQCI's Quality System aligned with standards and inspections.

The role offers rapid exposure to quality systems, audits, CAPA, document control, SOPs, and cross-department collaboration.

Qualifications

• Bachelor’s degree in Life Sciences with 5+ years in a cGMP-regulated environment, including at least 2 years in Quality Assurance.
• Knowledge of GMP regulations, ISO13485, and IVDR is preferred.
• Strong written and verbal communication skills; proficient in Microsoft Suite.
• Excellent proofreading skills with strong attention to detail.
• Ability to manage multiple priorities in a fast-paced environment.

Responsibilities

• Review and approve all QMS documentation (e.g., batch records and QC testing) to ensure compliance with QMS standards.
• Collaborate with departments to investigate Material Review Notifications and develop CAPA plans.
• Independently review and authorize process and equipment validations.
• Perform or assist with audits (internal, customer, regulatory).
• Maintain MMQCI’s ISO13485 certification.
• Write SOPs and train key personnel as needed.

Skills

Strong communication

Attention to detail

Multi-tasking

Team collaboration

Willingness to learn

Clear communication

Education

Bachelor's degree in Life Sciences

Tools

Microsoft Suite

Job description

MMQCI, a Southern Maine diagnostics company, is seeking a QA/RA Specialist to support quality assurance activities and regulatory compliance within an ISO 13485 environment. Reporting to the QA/RA Manager, you will maintain policies and procedures that keep MMQCI's Quality System aligned with standards and inspections.

The role offers rapid exposure to quality systems, audits, CAPA, document control, SOPs, and cross-department collaboration.