Come Work With Us!

We are looking for a Quality Assurance Specialist to join our growing team. In this role, you will be responsible for implementing and supporting document control processes and general quality management system (QMS) activities. This position is crucial to maintaining Magenta’s high standards of quality and regulatory compliance.

Reports to: QA Manager

Responsibilities

• Operate and maintain the Electronic Quality Management System (eQMS).
• Oversee and support all Document Control activities, ensuring timely and accurate processing.
• Manage Document Change Orders (DCOs) and Engineering Change Orders (ECOs).
• Maintain and update the Device History Files (DHF) and Device Master Records (DMR).
• Collaborate with cross-functional teams to ensure compliance with internal procedures and regulatory requirements

• Bachelor’s degree in a relevant field (e.g., Life Sciences, Engineering, Quality Assurance).
• Minimum of 3 years of experience in a similar or relevant quality role within the medical device or life sciences industry.
• Strong written and verbal communication skills.
• Highly detail-oriented with excellent organizational abilities.
• Effective time management skills and the ability to prioritize tasks independently.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).
• Comfortable working both independently and within cross-functional teams.
• Fluency in English, both written and spoken.

We are looking for an Experienced Quality Assurance Specialist to join our QA Operations group and support the variety of activities related to QA Operations, such as:

• Lead QA Operations activities with regards to verifications/validations for an FDA reviewed complex, multidisciplinary, active investigational device.
• Lead and perform the Engineering Change Order (ECO) process from risk analysis through protocol approval.
• Verification, execution, and analysis of reposts until FDA-ready.
• Provide guidance to the R&D and Engineering teams on IQ/OQ/PV activities.

• B.A. or B.S. degree in a technical discipline, such as Engineering or Science. 
• 3-5  years of relevant experience in the medical device industry.
• Previous experience with medical device verification/validations, ECOs, medical device statistics
• Working knowledge of medical device international standards.
• Ability to work independently with minimal work direction and in a cross-functional team environment.
• Fluent in English with excellent writing skills, effective written and verbal communication skills. 
• Excellent computer skills, including a working knowledge of Microsoft Office applications.
• Strong time management abilities to ensure timely task completion. 
• Detail-oriented.

We are seeking an experienced Regulatory Affairs Associate to join our team.

The Regulatory Affairs Associate will support Magenta’s products from early feasibility through marketing authorization, ensuring compliance with regulatory requirements. This role will work closely with other departments to maintain regulatory adherence and facilitate successful product approvals

• Provide regulatory support for Magenta’s products from early feasibility through marketing authorization.
• Prepare and maintain regulatory submissions and registrations for Magenta’s products in relevant markets.
• Conduct technical reviews of data and reports for regulatory submissions to ensure accuracy and clarity.
• Assess changes to device design or processes to determine their impact on pending or existing registrations.
• Provide guidance to project teams on premarket regulatory requirements, labeling standards, and other compliance matters.
• Monitor and communicate updates on new or revised guidance, regulations, and industry initiatives to ensure regulatory compliance.

• Bachelor’s degree in a scientific, technical, or engineering discipline – must.
• Minimum of five years of Regulatory Affairs experience with the US FDA and EU regulatory agencies (Class II and/or Class III medical devices) – must.
• Alternatively, candidates with a strong background in Design Quality Assurance seeking to specialize in Regulatory Affairs will be considered.
• Excellent writing and editing skills.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions.
• Proficiency in standard MS Office applications.
• Fluency in English, both oral and written