Sr Quality Engineer (IVD/MDR/Vigilance)

Organization
Illumina, Inc.
Job Location
San Diego, CA 92122
Job Description

All About Us

Do you want to make a difference? Illumina’s mission is to improve human health by unlocking the power of the genome. If that inspires you, let’s talk. We’ve built a culture fueled by innovation, collaboration and openness, and established ourselves as the global leader in DNA sequencing and array-based technologies. Our people and our technology change lives by driving advancements in life sciences, oncology, reproductive health, agriculture and other emerging markets. We are deeply passionate about what we do, because we know that our work has the power to improve lives.

We’re an established company with a track record of phenomenal growth. Our revenue grew from $10 million in 2002 to approximately $2.2 billion in 2015. Our growth isn’t just revenue, we’ve been hiring the best and the brightest. Perhaps that’s why MIT has ranked Illumina near the top of its World’s Smartest Companies list three years running, including #1 in 2014. If you thrive in a brilliant, fast-paced, and mission-driven environment, Illumina is the place for you – imagine the possibilities.
 
 
 
Position Summary
 
This role has a primary focus of company on-market medical device and diagnostic products. In this role you will serve as the Quality resource to provide initial assessment of complaints worldwide. You will work closely with Customer Solutions, field staff and Regulatory Affairs on initiatives relating to complaint compliance and timely reporting.
 
Actively participate in product quality activities, including complaint investigations of company products. Facilitate cross functional discussions in identifying, documenting, analyzing and reporting quality issues and ensuring that customer feedback is appropriately evaluated. Keep informed of US and OUS regulatory compliance information, adverse event and field action reporting requirements. This position reports into the Quality Assurance Complaints team.
 
This role requires strong communication, interpersonal and organizational skills and a strong demonstrated understanding of US and OUS Medical Device and Diagnostics Regulations.
 
 
Responsibilities:
 

  • Primary QA point of contact for on-market medical device and diagnostic complaint assessments and post market surveillance
  • Work closely with investigation teams to identify, assess and track potential adverse events and/or field actions and escalate to Regulatory in a timely manner
  • Monitor new and revised regulatory requirements in the area of Regulatory Compliance and translate information into area processes 
  • Participate as the subject matter expert during audits and/or inspections as needed
  • Actively participate on Quality teams and cross-functional project teams as needed 
  • Facilitate the evaluation of complaints, including assessment, investigation, containment, review, approval and determination of on-going needs
  • Ensure adequacy of complaint records (e.g. investigations, CAPA, NCs)
  • Identifies, collects, trends, analyzes, and summarizes product quality data to identify product quality issues
  • Identifies product and process improvements to reduce complaints and cost of poor quality
  • Promotes global awareness and provides training to policy and procedures
  • Provides support in the execution of field actions
  • Contributes to the establishment and maintenance of product risk management
  • Provides recommendations for business process improvements as they are identified during the analysis, tracking, and trending of quality review inputs
  • Provides management with status updates on assigned responsibilities and goals and escalates issues in a timely fashion
  • Other activities as assigned

 
 
Educational:
 

  • Bachelor’s degree or equivalent in science or related field required.
  • Regulatory Affairs Certification desired
  • Additional coursework in regulatory or quality assurance strongly desired

 
Experience/Background:
 

  • 5+ years recent experience in Quality/Regulatory Affairs in a in vitro diagnostics device or medical device required.
  • Strong knowledge of U.S. FDA regulations of medical device/IVD adverse event and field action assessment, health hazard evaluation, product risk safety analyses, MDR/recall reporting, IVD/Medical Device labeling requirements and 21 CFR 820 and process requirements. Strong knowledge of Vigilance reporting to OUS regulatory agencies desired. 


Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. 

 

How to Apply

To apply for this position, please use the following URL:

https://ars2.equest.com/?response_id=e52c5e742a184d0adf21f0e4f4c4cf8b

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