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Technology Services

Technical lead MDR, PFMEA

Others, United States

Verified applicants only — secured by Polyguard

Job Summary

The Technical Lead will be responsible for leading the mdr, medical iso13485 process, Process Failure Mode Effect Analy(PFMEA) within the organization. They will oversee the technical aspects related to medical device reporting, ISO 13485 processes, and PFMEA.

The Document Control Associate owns the day-to-day lifecycle of controlled documents across the NeuWave quality management system, ensuring that procedures, work instructions, forms, and specifications are created, revised, approved, distributed, and retired in accordance with FDA 21 CFR Part 820, ISO 13485, and EU MDR requirements. This role administers the eQMS document module — routing change requests through review and approval, maintaining accurate revision history, managing training assignments tied to document releases, and supporting periodic document reviews. The Associate serves as the primary point of contact for the broader business on document status questions, controlled copy requests, and obsolete document retrieval.The ideal candidate brings 2–4 years of document control experience in a regulated medical device, pharmaceutical, or similarly controlled environment, with hands-on eQMS administration experience (ComplianceQuest, or comparable). Strong attention to detail, comfort with electronic signatures and audit trail requirements under 21 CFR Part 11, and exceptional collaboration and communication skills are essential.

Key Responsibilities

1. Provide technical leadership and guidance on mdr and medical device regulations.
2. Implement and maintain iso 13485 processes to ensure compliance.
3. Conduct process failure mode effect analysis (pfmea) to identify and mitigate risks in processes.
4. Collaborate with cross functional teams to drive continuous improvement in quality and regulatory processes.
5. Develop and update standard operating procedures (sops) related to mdr, medical devices, and pfmea.
6. Train and mentor team members on technical aspects and best practices in medical device regulations.

Skill Requirements

1. In-depth understanding of mdr regulations and medical device reporting processes.
2. Proficiency in implementing and managing iso 13485 quality management systems.
3. Experience in conducting process failure mode effect analysis (pfmea) in a regulated industry.
4. Strong analytical and problem-solving skills.
5. Excellent communication and interpersonal abilities to collaborate effectively with diverse teams.
6. Attention to detail and strong organizational skills to ensure compliance and quality standards are met.

Other Requirements

1.Relevant certifications in medical device regulations, ISO 13485, or PFMEA are a plus.

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