Senior Supplier Quality Engineer

Reposted 3 Days Ago
Be an Early Applicant
Woodlands, SGP
In-Office
Senior level
Healthtech • Biotech
The Role
Manage supplier qualification and performance for medical/genomic product components. Communicate specifications, perform audits, lead supplier risk assessments, resolve supplier nonconformances, and support continuous improvement and GMP compliance across the supply base.
Summary Generated by Built In
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:

​Interfaces with development and supplier engineering to provide materials and components for company product manufacturing. Communicates product specifications to suppliers and assesses supplier’s ability to meet engineering and quality requirements. Evaluates suppliers’ internal functions to assess their overall performance and provides feedback in assessment of their operation. Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness. Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur. Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.

Position Responsibilities: 

  • Responsible in selection of new suppliers and partners for materials and services

  • Responsible for leading evaluation and qualification activities of Suppliers providing direct material/service.

  • Participate as a core/extended Quality team member of new product development and sustaining teams to assure processes are in place to design and release highly reliable and safe products

  • Drives process, quality and product improvements through supplier development activities, risk management, identification and resolution of current and potential issues

  • Responsible for updates to purchasing control procedures and processes as needed to stay compliant to quality system requirements and regulations. Provides Quality Assurance expertise and guidance for New Product Development, Manufacturing Operations, Supplier Development, and Product Quality

  • Leads purchased material qualification/re-qualification activities such as performance qualification, process validation, first article inspection, measurement gage analysis and capability studies

  • Maintain goals and metrics for existing and new products, regularly reporting on the progress to reach departmental objectives

  • Leads supplier audits to drive process standardization and continuous improvement

  • Identify opportunities for reduced inspection of purchased materials based on risk and quality performance

  • Leads and facilitates failure investigations; ensuring mitigations and corrective actions are implemented in a timely manner

  • Make recommendations, and drive programs to improve purchased material and supplier performance

  • Reviews non-conformance and CAPA reports to identify actions needed to track and improve program health by site or globally.

  • Works with strategic partners and suppliers to ensure global awareness and compliance to procedures and specifications

  • Ensures effective transfer of Suppliers from development to production activities

  • Ability to provide training to other team members to ensure consistency and compliance to processes and procedures.

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Position Requirements: 

  • Experience collaborating with cross-functional product development and operational teams

  • Strong communication and negotiation skills

  • Experience with Quality, Project Management, and Process Engineering methodologies and tools

  • Experience with Non-conformance Handling, Failure Investigation (CAPA/SCAR) and Risk Management (FMEA) activities.

  • Demonstrated capability in successfully managing and leading change

  • Practice identifying, mitigating, and resolving risks

  • Ability to work effectively in a fast-paced, dynamic environment with shifting and competing priorities

  • Demonstrated experience in Supplier Quality and Management activities such as component qualification, audits, risk assessments.

  • Experience with electronic product life cycle (PLM) systems such as Agile, SAP or other PLM systems.

  • Practical experience in FDA and ISO regulated environments is a plus

  • Experience with statistical analysis packages such as JMP and Minitab is a plus

  • Ability to travel domestically and internationally as needed. Estimate 25% of the time.

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

Preferred Experience/Education/Skills: 

  • Experience working in a regulated environment, in-vitro diagnostics preferred

  • Requires a minimum of 5 years of related experience with a Bachelor’s degree; or 3 years and a Master’s degree in Engineering, Life Sciences, or related field.

  • Minimum 3 years specifically working as a Supplier Quality Engineer or in a closely related Supplier Relationship function. Demonstrated track record in component qualification, vendor audits, and supplier risk assessments.

  • Deep understanding of failure investigation (CAPA/SCAR), Risk Management (FMEA), First Article Inspection (FAI), and Mistake Proofing.


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 [email protected]. 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.

Skills Required

  • Practical application of problem solving processes (CAPA/SCAR)
  • Risk management using FMEA
  • Non-conformance handling and continuous improvement tools
  • Strong cross-functional collaboration, negotiation, and communication skills
  • Willingness to travel domestically and internationally (~25%)
  • Familiarity with FDA 21 CFR Part 820, ISO 13485, and supplier management processes (component qualification, risk assessments, audits)
  • Bachelor's or master's degree in Engineering, Life Sciences, or related field
  • Minimum 3 years working as a Supplier Quality Engineer or closely related supplier relationship function
  • Deep understanding of failure investigation, First Article Inspection (FAI), and mistake proofing

Illumina Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Illumina and has not been reviewed or approved by Illumina.

  • Healthcare Strength Health coverage includes comprehensive medical (HMO/PPO), dental, vision, mental health, life, and disability insurance with options such as FSAs/HSAs and wellness resources. Offerings are described as robust across regions with customization in certain locations.
  • Leave & Time Off Breadth Time-off programs include flexible schedules and remote work, PTO or flexible time off, paid holidays and sick leave, and volunteer time. Company-wide shutdowns during summer and winter add additional paid time away.
  • Parental & Family Support Family-focused programs include fertility assistance, adoption assistance, and reproductive health support alongside family medical leave. Paid parental leave is provided, with specifics varying by country and employment status.

Illumina Insights

Am I A Good Fit?
beta
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company
HQ: San Diego, CA
7,400 Employees
Year Founded: 1998

What We Do

Illumina is an innovative technology and revolutionary assays aiming the analyze genetic variation and function.

Similar Jobs

In-Office
Singapore, SGP
34760 Employees

Micron Technology Logo Micron Technology

Senior Engineer

Artificial Intelligence • Hardware • Information Technology • Machine Learning
In-Office
Singapore, SGP
45000 Employees

Micron Technology Logo Micron Technology

Facilities Ultra Pure Water and Waste Water Engineer

Artificial Intelligence • Hardware • Information Technology • Machine Learning
In-Office
Singapore, SGP
45000 Employees

Micron Technology Logo Micron Technology

Capital Supplier Mgr, FE Pro Site Ops SG

Artificial Intelligence • Hardware • Information Technology • Machine Learning
In-Office
Singapore, SGP
45000 Employees

Similar Companies Hiring

Camber Thumbnail
Fintech • Healthtech • Social Impact
New York, New York
90 Employees
Sailor Health Thumbnail
Healthtech • Social Impact • Telehealth
New York City, NY
20 Employees
Granted Thumbnail
Mobile • Insurance • Healthtech • Financial Services • Artificial Intelligence
New York, New York
23 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account