Design Quality Manager

Catalyst

Design Quality Manager


  Newton,
Posted
2 weeks ago
Duration
Permanent
Salary
$165,000 - $200,000
Sector
Quality

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Opportunity for a Design Quality Manager to work with my client who have invented a ground-breaking combination device that will enhance surgeons’ ability to detect and remove cancerous cells during breast surgery. This a chance to be a core team member in supporting new product development and sustaining engineering projects, while also mentoring the engineering team to develop skills.

Role Responsibilities:

  • Make key decisions in guaranteeing compliance by internal functions to regulations, practices and policies on device related to development and post launch activities for medical devices
  • Lead investigations of potential product failures in support of the complaint and CAPA processes. Assure that work is conducted in a sound, scientific manner and documented using compliant practices.  Utilize applicable quality engineering and six sigma tools as part of the process.
  • Lead design control activities in accordance with all applicable SOPs. Assures the content of design file documents meet regulatory and company requirements. Assure process maps, control plans, design verification and design validation activities are complete, statistically sound, and compatible with the risk of the operation and device.
  • Establishing and maintaining the Quality Engineering function to ensure an efficient pre- and post-production quality assurance program, from design and development through manufacture and release of medical devices.

Experience Required:

  • Minimum 10 years’ experience in Quality Engineering within the medical device industry
  • Bachelor’s degree in engineering or Science required. (Prefer Masters within Engineering/ Engineering Management or Science discipline or equivalent experience.)
  • Minimum 3 years’ experience in Quality Management

We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.

Sathusan.Ravikumar

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Contact

Email
+44 (0) 20 3589 9300
 

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