Kforce

Senior / Principal Quality Engineer (Catheters)

1 week agoCarlsbad, CA

Responsibilities

Kforce is seeking a Sr/Principal Quality Engineer (Catheters) in Carlsbad, CA.Summary:The Sr/Principal Quality Engineer (Catheters) will support Quality Assurance, R&D, Manufacturing Engineering, and Operations in the design and manufacture of disposable medical catheters, in compliance with applicable regulatory and statutory requirements, including but not limited to 21 CFR 820 (Quality System Requirements), EN ISO 13485:2016, EN ISO 14971:2012, and CGMP. The Sr/Principal Quality Engineer (Catheters) will have past catheter or stent experience and will also assist with design controls, design transfer, and design change of cardiac electrophysiology catheters.Responsibilities:

  • Represents Quality Assurance during the Design Control (catheters) and Design Review (catheters) process through review and approval of the applicable Design Input, Design Output, Design Verification, Validation, and Design Transfer
  • Performs planning, testing, qualifications, and release of design change to released products, as required during the life cycle of commercialized devices
  • Supports manufacturing of disposable devices by solving Quality-related issues for disposable devices, using a hands-on approach and cooperation with manufacturing engineering
  • Performs and/or reviews product acceptance testing; Reviews and approves test results; Creates, reviews, and approves device history records
  • Assists with the definition and deployment of downstream processes, such as field service procedures, evaluation of spares, and investigation of product returns
  • Is a driver of change and decision-making within the department; Contributions are essential to the overall company's objectives
  • Supports all company internal and external audit functions and coordinate activities of third-party audits/visits
  • Consistently demonstrates technical proficiency and developing innovative solutions; Anticipates and provides solutions for obstacles and challenges


Skills

  • Typically requires a minimum of 6 years of related experience and a Bachelor's and/or Master's degree, in a Scientific/Engineering discipline; Or equivalent combination of education and experience
  • Experience in catheter design and production, or with similar medical devices, while working within Quality is required
  • Applied understanding of 21 CFR 820, EN ISO 13485:2016, ISO 14971:2012
  • Demonstrated experience in Design Controls and Risk Analysis
  • Demonstrated expertise in Process Validation, Product Validation, and Statistical Methods
  • Must be able to understand job duties and responsibilities, have the necessary skills/knowledge and be willing and able to continue learning and growing within the field
  • Must be skilled at managing a significant workload and obtaining positive results, taking on additional responsibility and managing priorities as needed
Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Kforce is a professional staffing services firm offering Technology and Finance & Accounting jobs with top employers nationwide. We specialize in providing contract, contract-to-hire and direct placement opportunities, with over 50 years of experience in the staffing industry. Kforce offers many consultants comprehensive benefits depending on employment status, including medical, dental, 401(K), life insurance and disability. Our vision is to be "the firm most respected by those we serve."

Job ID: Kforce-1943840-WQG