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Quality Engineer

Posted by: Ativa Medica

Posted date: Dec-17-2015

Location: St. Paul, MN

Quality Engineer Position

 

 

 

 

We are seeking an experienced quality engineer to support routine operations and product development activities.  In general, this engineer will be responsible for generating internal procedures, risk analysis documentation, assisting with verification strategy, and executing individual test plans and reports.  In addition to these duties, the position will create inspection documentation for incoming materials and on-site production.  They will review manufacturing documentation such as non-conforming material reports, manufacturing procedures, in process inspections, and special work orders. 

 

Primary Duties and Responsibilities:

  • Proficient knowledge and use of applicable industry standards
  • Technical writing of clear and detailed, procedures, test protocols and reports.
  • Analyzing test data using standard statistical techniques.
  • Generating risk analysis documents such as Design FMEAs, Process FMEAs, Hazard Analysis, and User Risk Analysis.
  • Review and evaluate non-conforming materials.
  • Work with vendors to correct material non-conformances
  • Generate inspection procedures for both incoming parts and on-site production.
  • Review manufacturing documentation for accuracy and clarity.
  • Manage traceability of design features to verification and risks to mitigation
  • Lead process validation activities
  • Represent the Quality function on a product development project core team level.

 

 

Qualifications (Knowledge, Skills & Abilities)

·         Strong knowledge with industry standards (including ISO 13485 & 14971, FDA QSR)

·         BS in Mechanical Engineering or a related field

·         3+ years of Life Sciences Industry experience

·         Experience with statistical methods and terminology

·         Effective oral and written communication skills

·         Demonstrated organizational and administrative skills.

·         Ability to prioritize and handle multiple tasks.

·         Demonstrated problem-solving skills

 

Preferred

·         3-5 years’ experience as a quality engineer in an IVD medical device environment

·         Experience handling supplier quality

 

 
Job Title Quality Engineer
Post Details
Email careers(at)ativamed.com
Employer's Website www.ativamed.com
Category
Job Discipline Job Discipline -> Biotech
Job Classification Job Classification -> Engineering
Job Type Job Type -> Full-time
Location St. Paul, MN
Key Words Quality
Start Date January 18, 2016
Deadline