Quality Assurance Specialist

Job Summary

The Quality Assurance/Regulatory Affairs Specialist supports quality assurance activities and ensures compliance with applicable regulatory requirements. Reporting to the Manager of QA/RA, this role maintains policies and manages procedures that support MMQCI’s Quality System in alignment with ISO 13485 standards.

About the Role

This role offers the opportunity to quickly build expertise while working in a collaborative environment. The ideal candidate brings experience working within an ISO 13485-regulated environment and is comfortable supporting and maintaining quality systems.

Responsibilities

• Review and approve all Quality Management System documentation (i.e. batch records and QC testing) to ensure compliance with QMS certifications and investigations
• Collaborate with departments to investigate Material Review Notifications and develop Corrective and Preventive Action plans
• Independently reviews and authorizes process and equipment validations
• Performs or assists with audits, including internal, customer, and regulatory audits
• Maintains MMQCI’s ISO 13485 certification
• Writes SOPs and trains key personnel as needed to support all departments
• May be called on to assist others and perform additional tasks as assigned

Requirements

• Bachelor’s degree in Life Sciences with 5+ years’ experience in a cGMP-regulated environment, including at least 2 years in Quality Assurance
• Knowledge of current GMP regulations, ISO 13485, and In Vitro Diagnostic Regulation (IVDR)
• 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, changing environment and meet challenging deadlines
• Strong work ethic, team-oriented mindset, and willingness to learn
• Ability to communicate clearly and constructively

Qualifications

• Must be able to lift up to 30 lbs

Benefits

Opportunity to make a meaningful impact within a growing diagnostic company
Collaborative, mission-driven team environment
Competitive compensation and benefits
Benefits We Offer:
- Medical, dental, and vision insurance
- 401(k) retirement savings plan
- Company profit sharing program
- Paid time off, including vacation, holidays, and sick leave
- Paid Parental Leave Program

Schedule

Flexible schedule to accommodate the needs of a growing diagnostic company

Contact Information

Interested in joining our team? Please submit both a resume and cover letter with your application for consideration.

Learn more about the MMQCI team!