Senior Mfg/Ops Quality Engineer

3 Minutes ago • 5 Years + • Quality Assurance

Job Summary

Job Description

At Illumina, we are expanding access to genomic technology to realize health equity for billions of people. Our efforts enable life-changing discoveries that are transforming human health through early detection and diagnosis of diseases and new treatment options. Working at Illumina means being part of something bigger, with opportunities to make a difference. This role ensures design transfer and manufacturing operations comply with Illumina’s Quality Management System (QMS) and regulations, including validation, non-conformance, customer complaints, and risk assessment.
Must have:
  • Serve as Quality representative on project teams for new product transfers
  • Review and approve manufacturing operational activities (DHR, nonconformance, CAPA, RMA, customer complaints)
  • Work with cross-functional teams to resolve operational quality issues
  • Trend, analyze and monitor key performance indicators, suggest improvements and escalate
  • Ensure quality systems meet customer, corporate, or internal requirements
  • Participate in management of corrective action program (customer complaints)
  • Manage customer complaints and work closely with cross function in issue investigation and ensure timely response
  • Work in accordance with procedures and integrated program plans for FDA and ISO third party audits
  • Bachelor’s degree in Engineering or Biological/Life Sciences or equivalent field
  • Minimum 5 years of experience in a medical device manufacturing environment
  • Ability to apply experience to meet 21 CFR 820 and ISO 13485 requirements
  • Experience in failure investigation, technical report writing, data mining, trend analysis and statistical analysis
  • Intermediate to advanced experience with words processing and spreadsheets, charting, graphing tools and presentation tools
  • Proficient in computer systems such as Microsoft Office & SAP
Good to have:
  • Certified Quality Engineer
  • Experience with statistical analysis packages (JMP, Minitab)
Perks:
  • Expanding access to genomic technology to realize health equity for billions of people
  • Enable life-changing discoveries transforming human health
  • Early detection and diagnosis of diseases and new treatment options for patients
  • Being part of something bigger than yourself
  • Opportunity to make a difference
  • Surrounded by extraordinary people, inspiring leaders, and world changing projects
  • Deeply rooted in belonging, promoting an inclusive environment
  • Employees feel valued and empowered to contribute to our mission
  • Prioritized openness, collaboration, and seeking alternative perspectives to propel innovation
  • Zero-net gap in pay, regardless of gender, ethnicity, or race
  • Employee Resource Groups (ERG) for career development, cultural awareness, and social responsibility

Job Details

What if the work you did every day could impact the lives of people you know? Or all of humanity?

At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.

Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.

Position Summary:

This role is responsible to ensure that design transfer and manufacturing operations activities are executed in compliance with Illumina’s established Quality Management System (QMS) and relevant international/national regulations. These activities include, but are not limited to, validation, non-conformance, customer complaints, risk assessment and support maintenance of the QMS.

Position Responsibilities:

  • Serve as Quality representative on project teams for new product transfers
  • Review and approve manufacturing operational activities, such as Device History Records (DHR), nonconformance, CAPA, RMA, and customer complaints
  • Work with cross-functional teams to resolve operational quality issues
  • Trend, analyze and monitor key performance indicators, suggest improvements and escalate to supervisor/management as necessary
  • Ensure the quality systems meet customer, corporate, or internal requirements and any other related requirement within the Quality Management System
  • Participate in management of corrective action program (customer complaints) to ensure timely follow-up, completion and documentation of corrective actions
  • Manage customer complaints and work closely with cross function in issue investigation and ensure timely response of to corporate/ customer
  • Work in accordance with procedures and integrated program plans for achieving and maintaining the required level of product quality in preparation for FDA and ISO third party audits

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

Position Requirements:

  • Bachelor’s degree in Engineering or Biological/Life Sciences or equivalent field
  • Minimum 5 years of experience in a medical device manufacturing environment.
  • Excellent interpersonal, verbal and written communication skills
  • Ability to apply experience to meet 21 CFR 820 and ISO 13485 requirements
  • Strong analytical, problem-solving and decision-making skills; Certified Quality Engineer, or equivalent, is a plus
  • Experience in failure investigation, technical report writing, data mining, trend analysis and statistical analysis
  • Intermediate to advanced experience with words processing and spreadsheets, charting, graphing tools and presentation tools
  • Proficient in computer systems such as Microsoft Office & SAP
  • Experience with statistical analysis packages, e.g. JMP, Minitab is highly preferred

We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. 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. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants.

Similar Jobs

Looks like we're out of matches

Set up an alert and we'll send you similar jobs the moment they appear!

Similar Skill Jobs

Looks like we're out of matches

Set up an alert and we'll send you similar jobs the moment they appear!

Jobs in Singapore

Looks like we're out of matches

Set up an alert and we'll send you similar jobs the moment they appear!

Quality Assurance Jobs

Looks like we're out of matches

Set up an alert and we'll send you similar jobs the moment they appear!

About The Company

At Illumina, our goal is to apply innovative technologies and revolutionary assays to the analysis of genetic variation and function, making studies possible that were not even imaginable just a few years ago. These studies will help make the realization of personalized medicine possible. With such rapid advances in technology taking place, it is mission critical to have solutions that are not only innovative, but flexible, scalable, and complete with industry-leading support and service. As a global company that places high value on collaborative interactions, rapid delivery of solutions, and prioritizing the needs of its customers, we strive to meet this challenge. Illumina’s innovative, array-based solutions for DNA, RNA, and protein analysis serve as tools for disease research, drug development, and the development of molecular tests in the clinic.



San Diego, California, United States (On-Site)

Bengaluru, Karnataka, India (On-Site)

San Diego, California, United States (Hybrid)

San Diego, California, United States (On-Site)

Eindhoven, North Brabant, Netherlands (On-Site)

Bengaluru, Karnataka, India (On-Site)

San Diego, California, United States (On-Site)

View All Jobs

Get notified when new jobs are added by Illumina

Level Up Your Career in Game Development!

Transform Your Passion into Profession with Our Comprehensive Courses for Aspiring Game Developers.

Job Common Plug