Back to Job SearchROLE OVERVIEW
We are currently looking for a Design Control Lead to join a leading medical device company remotely in the US. This is an exciting opportunity for a professional with a strong background in design controls to contribute to pivotal remediation projects within a regulated environment. The role offers the chance to be part of a dynamic team supporting critical project delivery until the end of 2026, providing valuable experience in a fast-paced life sciences sector.
As the Design Control Lead, you will be instrumental in driving design control remediation activities, ensuring compliance, and maintaining quality standards. This contract position provides an excellent platform for a proactive individual seeking to make a significant impact within a global industry leader.
KEY DUTIES AND RESPONSIBILITIES
Your duties as the Design Control Lead will be varied however the key duties and responsibilities are as follows:
- Serve as Design Control Remediation Sub-Workstream Lead, providing technical direction, escalation management, and decision support for Design History File (DHF) remediation activities.
- Lead execution of design control remediation activities, ensuring alignment with remediation plans, procedures, and program objectives.
- Own and manage CAPAs related to design control observations, ensuring corrective actions are effectively implemented and sustained.
- Oversee cross-functional teams executing remediation workstreams, ensuring deliverables, timelines, and quality standards are met.
- As the Design Control Lead, you will coordinate with regulatory teams to ensure compliance with applicable standards and facilitate ongoing readiness.
ROLE REQUIREMENTS
To be successful in your application to this exciting role as the Design Control Lead we are looking to identify the following on your profile and past history:
- A Degree or higher level in a related field.
- Proven industry experience in medical device design controls within a regulated environment.
- A working knowledge and practical experience with ISO 14971 risk management principles and their application across design control processes and deliverables.
WHAT’S IN IT FOR YOU?
Joining our client as a Design Control Lead offers the opportunity to work on impactful remediation projects within a leading medical device organization. You’ll gain valuable experience in a highly regulated environment, with the flexibility of remote working and a contract position supporting your career development in the life sciences sector.
Key Words: Design Control Lead / medical device / remediation project / remote / contract / Design History File / DHF / CAPA / ISO 14971 / risk management / regulatory readiness / FDA QMSR / ISO 13485:2016
"Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career."
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
