Role details

Senior Quality Engineer

Danbury   •  Permanent

Bullet points

  • A leading world class medical device manufacturer
  • Hiring an innovative Senior Quality Engineer with previous industry experience

About Our Client

Located near Danbury, CT - our client is a market leader in the manufacturing of diagnostic medical technology that saves lives every single day. The team is currently looking for an innovative Senior Quality Engineer with previous industry experience to join their team.

Job Description

The Senior Quality Engineer will be responsible for, but not limited to the following:

  • Provide quality related support to all areas of the plant as necessary
  • Provide guidance and decision making on quality related issues as they arise
  • Conduct, document, and track investigations for non conformance and/or customer complaints
  • Lead CAPA investigations including identification of root cause and corrective or preventive actions
  • Collect and summarize data for investigations; perform trending analysis Author and/or revise Standard Operating Procedures as required
  • Read and understand descriptions, communications, reports, tables, diagrams, directions, regulations, etc.
  • Lead or participate Quality auditing as part of the Sage Quality System
  • Lead or participate in or lead Quality improvement initiatives
  • Effectively manage quality projects and ensure timely completion
  • Maintain current knowledge of applicable domestic and international regulations

The Successful Applicant

The preferred candidate for the Senior Quality Engineer will have the following background and experience:

  • Bachelors of Science degree in Engineering, Science or other related field
  • Minimum of five years of relevant works experience
  • ASQ Certification, Certified Quality Engineer or Certified Quality Auditor, preferred
  • Competent with Six Sigma tools and application, Green Belt preferred
  • Experience in a cGMP regulated pharmaceutical and/or medical device environment is required
  • Familiar with FDA regulations as they pertain to Sage Products, specifically 21CFR211 and 21CFR820
  • Familiar with international standards and regulations as they pertain to Sage Products (i.e. Health Canada, MDD, ISO13485, etc.)
  • Knowledge and skills in quality-related methods, techniques and application including problem solving, process management, assessment and metrics

What's on Offer

Our client offers a competitive compensation package, great benefits and unlimited opportunities for career progression within a world class, growing organization!

Apply for this job

Click the Apply or LinkedIn button below or contact Ricki Chiem quoting job reference 1209287
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