Job Description

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.

The Senior Engineer, Quality, is responsible to ensure design transfer and manufacturing operations activities are executed in compliance with Illumina\xe2\x80\x99s established Quality Management System (QMS) and relevant international/national regulations. These activities include, but are not limited to, validation, nonconformance, customer complaints, risk assessment and support maintenance of the QMS.

All About You

Responsibilities:

Serve as Quality representative on project teams for new product design transfers

Review and approve validation protocols and reports; ensure compliance with established procedures and sound validation methodology

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

Other such duties that may be determined by Supervisor

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.

Requirements:

More than 5 years experience in a medical device manufacturing environment

Competencies:

Excellent interpersonal, verbal and written communication skills

Ability to apply experience to meet 21 CFR 820, NMPA 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

May have experience with statistical analysis packages, eg, JMP, minitab

Education:

Bachelor\xe2\x80\x99s degree in Engineering or Biological/Life Sciences

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.

Illumina