Quality Lead Engineer (Medical Device Validation) Job at Lorven technologies, Reedsville, PA

  • Lorven technologies
  • Reedsville, PA

Job Description

Hi,

Our client is looking for Quality Lead Engineer (Medical Device Validation) - Reedsville, PA below is the detailed requirements.

Job Title: Quality Lead Engineer (Medical Device Validation)

Location: Reedsville, PA

Job Description:

  • Bachelor's degree in Computer Science, Information Technology, Engineering, or related field with 8 12 years of overall IT experience.
  • 8+ years of Medical Device Quality experience.
  • Experience with Class II/III medical devices.
  • Experience supporting FDA, MDSAP, and ISO audits
  • Manage CAPA, Nonconformance, and Deviation activities.
  • Conduct Root Cause Analysis and corrective actions.
  • Review quality metrics and identify recurring issues.
  • Support quality audits and FDA readiness programs.
  • Collaborate with cross-functional teams on quality improvements.

Required Skills:

  • CAPA, Nonconformance, and Deviation Management.
  • Root Cause Analysis (5 Why, Fishbone, FTA).
  • Quality Metrics and Trend Analysis.
  • FDA 21 CFR Part 820, ISO 13485, ISO 14971.
  • Design Controls and Validation Support

Job Tags

Similar Jobs

CA Conservation Corps

Conservationist I Job at CA Conservation Corps

 ...Job Description and Duties Under the direction of the Conservation Supervisor, the Conservationist I performs the following duties: Supervise, Train and Evaluate Corpsmembers. Teach, Direct and Counsel Corpsmembers. Care, Maintenance and Security of State... 

Retro Fitness

Kickboxing Class Instructor Job at Retro Fitness

Benefits:~Company parties~Employee discounts~Flexible schedule~Free uniforms~Wellness resources~Opportunity for advancement~Training & developmentJob SummaryReporting to the Director of FItness and/or General Manager, the Group Kickboxing Class Instructor...

Trademark Metals Recycling LLC

Dispatcher Job at Trademark Metals Recycling LLC

 ...equipment moving efficiently weve got a seat for you. As a Dispatcher at Trademark Metals Recycling, youre the nerve center of the operation...  ...experience and billing knowledge are a strong plus well train the right person on the rest. What We're Looking For:*... 

Family Resource Home Care

Certified CNA In Home Caregiver Job at Family Resource Home Care

 ...proud to offer competitive pay to our caregivers based on their experience and licensure. Pay range [$22-$23.50] Why Family Resource...  ...Transporting clients for errands or appointments in your car ~ Assisting with gait belt or Hoyer transfers ~ Monitoring and... 

KDG Construction Consulting

Senior Airport Manager Job at KDG Construction Consulting

 ...KDG Construction Consulting is seeking an experienced Senior Airport Manager who is responsible for the safe and efficient operation of the airport. This position oversees day-to-day airside, landside, maintenance, subtenant coordination, budgeting, emergency response,...