Quality Specialist

Job Title: Quality Specialist
Location: Philadelphia PA
Duration: 12 months

Job Description:
The Quality Specialist ensures compliance with ISO 13485 MDSAP EU MDR 2017/745 US FDA 21 CFR Part 820 and other regulatory requirements. This role supports Deep Healths Quality Domain enhancing customer satisfaction and team collaboration.

Education & Experience:

• Education: B.E. in Mechanical or Biomedical Engineering.
• Experience: 68 years in Medical Devices Quality (SaMD experience preferred).

Role and Responsibilities:

• Ensure compliance with ISO 13485 MDSAP EU MDR 2017/745 US FDA 21 CFR Part 820.
• Support QMS integration across sites.
• Maintain quality procedures and work instructions for CAPA complaints supplier quality training internal audit risk and design remediation.
• Assist with design remediation including DHF risk files and cybersecurity.
• Support ongoing design projects and LMS implementation.
• Validate data and document migration.
• Resolve technical queries promptly.
• Engage with clients and crossfunctional teams.
• Deliver customized solutions to meet client needs.
• Ensure process compliance and meet delivery schedules.

Skills:

• Quality Management System (QMS): Handson experience with Quality Specialist roles in SaMD/Software Products.
• Cybersecurity: Implementation of cybersecurity guidelines.
• Technical Skills: Proficient in Microsoft Office (Excel PowerPoint Outlook Teams).
• ProblemSolving: High learning agility and quick issue resolution.
• Customer Orientation: Able to meet customer demands and tight deadlines.
• SelfMotivation: Proactive organized and teamoriented.
• Communication: Strong verbal and written skills in English.
• Interpersonal Skills: Effective communication with diverse stakeholders mainly virtually.