Job title: CQV Engineer – Medical Device
Company: Intellectt
Job description: Job Title: CQV Engineer Medical Devices
Location: Plymouth,MN
Duration: long termJob Description:
We are seeking an experienced CQV (Commissioning, Qualification, and Validation) Engineer to support the development and validation of equipment, systems, and processes for our medical device manufacturing operations. The ideal candidate will have a minimum of 5 years of experience in CQV within the medical device industry, with a solid understanding of FDA regulations and ISO 13485 standards. This role requires a strong technical background and hands-on experience with commissioning, qualification (IQ, OQ, PQ), and validation activities to ensure compliance and optimal performance of equipment and processes.Key Responsibilities:
- Lead and execute commissioning, qualification (IQ/OQ/PQ), and validation activities for medical device equipment, systems, and processes.
- Develop detailed CQV protocols and execute tests to ensure equipment and systems meet regulatory and performance requirements.
- Ensure compliance with FDA, ISO 13485, and other relevant industry standards throughout all CQV activities.
- Collaborate with cross-functional teams, including quality assurance, engineering, and manufacturing, to resolve validation issues and improve processes.
- Perform risk assessments and implement mitigation strategies to ensure quality and compliance.
- Generate and maintain thorough documentation for all CQV processes, including protocols, reports, and regulatory submissions.
- Troubleshoot equipment and process issues and provide technical guidance to support validation success.
- Ensure the smooth transition of systems from development through qualification to commercial production.
Required Skills:
- Extensive knowledge of CQV processes (commissioning, IQ, OQ, PQ) within the medical device industry.
- Strong understanding of FDA regulations, ISO 13485, and GMP standards.
- Hands-on experience with equipment validation, process validation, and risk-based validation approaches.
- Strong problem-solving and troubleshooting skills for equipment and process-related issues.
- Excellent technical writing skills for developing validation protocols and reports.
- Ability to manage multiple validation projects, meet deadlines, and prioritize tasks in a fast-paced environment.
- Strong collaboration and communication skills to work with cross-functional teams.
- Familiarity with risk management tools such as FMEA (Failure Modes and Effects Analysis).
Expected salary:
Location: Plymouth, MN
Job date: Wed, 09 Oct 2024 22:21:12 GMT
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