Quality Engineer II

Job description

Quality Engineer II

Your Role:

·  As part of the Quality Systems team:
·  (50%) Daily Activities – Lab Analysis
·  Perform hands on analysis of customer complaints. This includes 0 – 3500L single use bags, tube sets, and other single use components.
·  Leak testing through use of air and water, confirmation of specifications, confirmation of accuracy compared to manufacturing drawings, and visual analysis (microscopic and camera images).
·  Assist in initial root cause analysis
·  Write an investigation report for each complaint analyzed
·  (50%) Daily Activities – Technical Writing
·  Write customer facing investigation reports
·  Manage cross functional teams to determine root cause and corrective actions.
·  Work with manufacturing and engineering to identify potential root causes.
·  Analyze manufacturing and complaint data using Microsoft Excel to uncover trends.
·  You will use Word and Excel software daily.

 

Who You Are:

 

Minimum Qualifications:

·  Bachelor’s degree in Engineering or Chemistry
·  1+ year's Engineering experience in FDA-regulated industry (pharmaceutical, biotechnology or medical device) or in life science industry
·  1+ years of experience with technical writing

 

 

Preferred Qualifications:

·  Bachelor’s Degree in Plastics Engineering, Biomedical Engineering, Mechanical Engineering or Chemical Engineering
·  Experience utilizing Microsoft Excel for data analysis
·  Experience with Trackwise software
·  Experience using Root Cause Analysis tools
·  Demonstrated ability to work with cross-functional groups
·  Knowledgeable in ISO 9001 and/or GMP
·  Experience with Excel and Word software
·  Self-directed and self-motivated
·  Excellent communication skills

Job Requisition ID: 207362

Location: Danvers

Career Level: C - Professional (1-3 years)

Working time model: full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

Nearest Major Market: Boston
Job Segment: Biotech, Medical, Pharmaceutical, Quality, Science, Healthcare, Customer Service