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SR. QUALITY ENGINEER--MEDICAL DEVICES (REMOTE)

UNITED STATES, UNITED STATES
You can apply at the link below as well:
https://kprecruitinggroup.catsone.com/careers/7781-General
 
​Salary: Please submit an application and we'll email you the salary info.
 
THE OPPORTUNITY:
 

The Senior Quality Engineer is a unique opportunity and an exciting time to join a pioneering company at a critical time in its growth. We're a global medical technology company built on nearly five decades of experience and a relentless commitment to improving the lives of patients around the world. Our disruptive technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals, and healthcare systems.

 

We are looking for a self-starter who likes challenges requiring critical thinking and has keen problem-solving skills. In this role, your work will include activities;

 

  • Serve as a core team member on product development teams by providing technical leadership and direction. Responsible for the risk management file, compliance with design control regulation, the completeness and sufficiency of verification and validation activities, and manufacturing quality and validation planning;

  • Review product and QMS changes for completeness, accuracy, and safety/effectiveness including the identification of all impacts

  • Identify and initiate product and labeling improvements based on compliant and trending data;

  • Collaborate with Operations to define and implement systems that enhance efficiency, productivity, and quality;

  • Provide quality criteria (risk assessment, acceptance criteria, sample size, parameter definition) for validation activities;

  • Ensure that procedures and processes are maintained and updated to be consistent with regulatory changes including the development of more efficient QMS processes and global QMS processes;

  • Comply and present quality data in management review;

  • Generate, maintain and update risk management documentation throughout the life cycle of a product;

  • Contribute to successful regulatory audits by coordinating back room/front room activities or serving as a subject matter expert;

  • Perform other duties as may be required by management.

 

Minimum Qualifications, Skills, and Abilities:

  • Bachelor’s Degree in Engineering. Mechanical, Electromechanical, Systems, Electrical (with mechanical exposure)

  • 5+ years of experience within the medical device space, R&D, regulatory or design development.

  • Expertise in scalability of process and product design for growth

  • Well versed with metrics and data driven approaches leading to quick and efficient adoption of continuous improvement initiatives

  • Expertise in MDR and Product standard experience.

  • Experience working with Class II or Class III Medical devices.

  • Experience working on project teams resulting in PMA and 510k submissions.

  • Travel requirements: be able to travel to Pittsburgh, PA 1 or 2 weeks a month

KP RECRUITING GROUP
 
KP Recruiting Group was started to create a world-wide network of multi-level, highly skilled talent; that are either experts or working to become one, in their respective fields. Our process involves focusing on the talent, skills, and experience of an individual as a key indicator of the present and future value that they will bring to any organization.

In establishing a network, we are able to forge genuine relationships with talent and gain valuable insight that allows us to understand what motivates them. This data allows us to give strategic advice to our partners as they go through the process of managing their human capital.

See our jobs and apply here: https://kprecruitinggroup.catsone.com/careers/7781-General

 
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