Job Opening

The Quality Systems Specialist will be actively involved in performing all Quality System related activities in a small business/ service-based environment. MetaSystems Group Inc. (MGI) an FDA regulated / ISO certified company, is committed to providing the highest quality imaging systems and probes for medical and other applications. The ideal candidate will work well in a team setting, whether remotely or in the office. An understanding of the company’s technical operations and product portfolio is essential for success in this position, as is a strong IT background. This is a full time position based in Medford, Mass. MGI offers an extensive benefits package including full coverage of medical and vision, with optional dental. Free parking as well as lunches and drinks are provided to all employees while working at Medford office.

Description

Position Obligations:

• Full-Time
• 60 % In Office and 40 % Remote (e.g. WFH)
• Boston-based position

Essential Duties & Responsibilities:

• Daily Complaint & Discovery case review and closing
• Day to day management and support for all QM systems (CAPA/ Nonconformances)
• Integration and maintenance of eQMS and applications into Company ERP System
• Information management within the eQMS
• Companywide training activities
• Statistical analyses and reporting

Collaborative Duties & Responsibilities:

• Applications Training
• SIDS review
• Verification & validation activities

Requirements

Required Skills & Qualifications:

• Working knowledge of application of QM systems for Medical Devices
• Basic understanding of GMP/FDA (21CFR820) & ISO Regulations (13485)
• Multitasking / Problem solving / Time management / Collaboration / Communication skills
• Attention to detail
• Strong IT skills
• Familiar with Salesforce or other ERP

Required / Desired Education & Experience:

• Minimum BS degree (preferably Biotechnology or related field)
• 1-5 years’ experience in Quality
• Internal auditor Training (desirable)