Senior Validation Professional- Medical Device
Join to apply for the Senior Validation Professional- Medical Device role at Brightwater Capital, LLC
About The Company
My client is a leading multinational medical device company, specialising in innovative solutions that improve quality of life.
About The Position
This is an exciting opportunity to manage the validation lifecycle and Advanced Product Quality Planning (APQP) processes for this busy medical device manufacturing plant.
Key Responsibilities
* Lead and Manage the Validation Team: Oversee daily operations, allocate work, and ensure high performance and quality output.
* Drive Validation Projects: Serve as the lead on all validation projects, ensuring alignment with protocols and production requirements.
* Ensure Compliance: Develop strategies to meet regulatory requirements, maintain validation policies and procedures, and manage the Validation Master Plan.
* Lifecycle Management: Oversee product and process transfers, manage PFMEA and control plans, and support post-validation activities.
* Technical Execution: Lead IQ, OQ, PQ, and process development activities, including DOE and MSA, to ensure process effectiveness.
* Cross-Functional Collaboration: Work closely with Operations, Planning, and Engineering teams to validate manufacturing processes.
* Regulatory Audits: Participate in regulatory audits and ensure all validation activities meet industry standards.
Experience/Requirements
* Minimum 5 years of high-volume engineering experience in the medical device industry.
* 3+ years of experience in validation processes.
* BA/BS Engineering or related technical qualification.
* Proficient in statistical techniques, including Minitab, Six Sigma (preferably Green Belt), and Sampling Plans/Sizes.
* Strong experience in process development, DOE, and risk management (FMEA).
* Excellent documentation skills and a strong understanding of process validation.
* Proven ability to lead a team, manage projects, and communicate effectively across departments.
* Strong problem-solving skills and the ability to work independently or as part of a team.
Remuneration Package
A competitive package is on offer which will include salary, benefits and bonus.
Contact
For more information on this position or other life sciences roles, please contact Charlie Bigger or email or simply click the apply button.
Skills
medical device validation, equipment, process development, Leadership
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Operations Consulting
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