Quality Assurance Nurse, Sr. jobs in South Burlington, VT

Nolato GW is a global leader in precision injection molding and contract manufacturing for the world’s most successful healthcare, automotive, and industrial OEMs.

Join an organization that is respected throughout the industry for our advanced technology, quality, and innovation – all while enjoying the benefits of stable ownership, a collaborative culture, professional development, continuing education, global opportunities, and an exceptional benefits package.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Read and follow all instructions on the Quality Assurance requirements document (QAR).
  Proof of Proficiency in all QAT duties.
• Must have a complete understanding of Good Manufacturing practices 21 CFR Part 820. Be able
  to teach GMP class to new personnel.
• Understand and enforce medical requirements (GMP) within all areas of the facility, key areas:
  Line Clearance, Containment and investigation of defective product and measurement:
  
  • Understand specialized duties in your facility such as clean room particulate testing, clean room
  gowning procedures, specialized testing such as bubble testing, pull-force testing and all other
  specialized testing.
  
  • Become proficient in the use of CMM equipment.
  • Perform FAI inspections
  • Perform gage R&R and validation studies.
  • Be proficient using SPC Explorer
  - Become a certified auditor to IS- 13485:2016 and IATF-16949
  
  • Understand and enforce IATF-16949 in facilities that require automotive regulation.
• Mentor and train new QATs and assist in helping them achieve QAT I status.
• Proficient to perform assembly device inspections per applicable procedures and customer requirements.
• Capability to lead and coordinate other team member's activities.
• Capability to work in all areas of the facility or cover any QAT position duties.
• Other duties as assigned.
• Strive to be a contributive and supportive member of the plant operations and quality team, be a role
  model in upholding quality disciplines in all area of your duties.

QUALIFICATIONS:

• This position requires a High School diploma or GED equivalent required.
• Strong leadership skills and experience.
• Previous quality control experience is required.
• Prior injection molding experience is desirable.
• Advanced computer skills are required.
• Internal auditor training
• Basic math skills are required.
• Working knowledge of advanced measuring equipment i.e. Vision systems, CMMs and other specialized
  equipment in the facility.
• Advance GMP understanding and the ability to lead contamination control in clean room and other
  environments.
• Knowledge of SPC analysis is required.
• 21 CFR part 820 compliance proficiency is a requirement.
• IATF-16949 Proficiency is a requirement.
• Written communication skills are a must, as this position requires detailed documentation of each
  assigned molding machine be properly recorded.
• Other duties may be required or requested.
• Minimum 3 years' quality control environment of FDA regulated manufacturing environment of 3 years'
  IATF regulated environment.
ASQ Certified Quality Inspector Certification plus.