Quality Assurance Associate

Organization
Luminex Corporation
Job Location
Madison, WI 53717
Job Description

POSITION SUMMARY

The Quality Assurance Associate participates in the design, creation, implementation and monitoring of programs and methodologies to ensure that Luminex products meet established specifications, design criteria, quality standards and customer requirements.

ESSENTIAL JOB DUTIES

Key Responsibilities of the Job:

  • Review and approve records for product release and documents for completeness & accuracy under a production schedule
  • Review and update (as authorized) quality system documentation
  • Review and approve Design and Development records (studies, reports and data) as assigned
  • Review and approve Design History Files
  • Track key performance metrics
  • Investigates and works with other departments to resolve quality issues related to area assigned
  • Participates in internal compliance audits to established Quality System Manual and applicable regulations and standards
  • Participates in continuous improvement efforts by completing corrective/preventive actions as assigned
  • Participate in performing CAPA effectiveness checks and CAPA follow-up
  • Prepares and collects materials for QA meetings and, as assigned, present materials at QA meetings.
  • Assist other Quality Assurance personnel in Material Review Board (MRB) activities as needed
  • Log, file, maintain and archive various QA reports & records, as assigned
  • Support and participate in other QA related activities as required
Requirements

JOB REQUIREMENTS

Required Work Experience:

  • 3 years of Quality Assurance experience in a manufacturing environment (5 years required if no post-secondary education degree)
  • Experience in a Good Manufacturing Practices (GMP) environment preferred
  • Experience in Medical Device Manufacturing environment preferred
  • Formal auditor experience preferred

 

Required Education/Training:

  • Associate degree in a science/engineering field, BS or BA degree preferred. In lieu of a degree, may substitute 5 years of experience in a Quality Assurance role in a regulated manufacturing environment.

 

Competencies:

  • Learning on the Fly—learns quickly/open to change
  • Organizational Agility—knows how to go through the proper channels to get things done
  • Peer Relationship—cooperative, team player, trusted and supported by peers
  • Planning—sets specific goals and objectives, ability to plan for the length and difficulty of assignments, ability to break down projects into specific tasks/steps
  • Priority Setting—focuses on what is most important
  • Written Communications—effectively communicates in writing

Required Certifications/License/Special Skills:

  • Good verbal and written communication skills
  • Certification in a quality discipline preferred, such as CQT, CCT, CQI, etc.
  • Computer skills (Microsoft Windows and Office programs), familiarity with Oracle preferred

 

About Our Organization

Luminex is committed to creating innovative, breakthrough solutions to help our customers improve health and advance science worldwide. We serve the needs of our customers in diverse markets including clinical diagnosticspharmaceutical drug discoverybiomedical research, including genomic and proteomic research,personalized medicinebiodefense research and food safety. Our goal is to transform global healthcare and life science research through the development, manufacturing, and marketing of proprietary instruments and assays that deliver cost-effective, rapid results to clinicians and researchers.

Luminex Corporation enjoys an entrepreneurial fast-pace environment of highly motivated and creative individuals. At Luminex we have a passion for innovation and are dedicated to positively impacting the health, safety and quality of life for people around the world. Luminex Corporation features an excellent compensation and benefit plan.

Should you take the challenge to change lives, Luminex has this immediate opening where you can make a difference.

Students whose classmates are interested in science are more likely to think about a career in science, technology, engineering, and mathematics, a new study says.

CNBC reports that the genetic counseling field is expected to grow as personalized medicine becomes more common.

Gladys Kong writes at Fortune that her STEM background has helped her as a CEO.

Social scientists report that the image of the 'lone scientist' might be deterring US students from STEM careers.