Mfg/Ops Quality Engineer 1

Socket.dev; California (MO); On-site; USD 63,000 - 94,000; Full time

Job summary

Illumina in the United States is seeking a Manufacturing and Operations Quality Engineer to support day-to-day sustaining activities in a regulated manufacturing environment. You will collaborate with Manufacturing and Process Engineering to drive validation, transfer activities, and CAPA programs, ensuring FDA and ISO compliance.

Ideal candidates have a Bachelor's degree in engineering or science with 0-2 years in quality assurance in regulated settings, plus experience with quality systems

Qualifications

• Bachelor's Degree in Engineering and/or Science; 0-2 years in quality assurance in a regulated environment; IVDD/QA exposure preferred
• Knowledge of quality regulations: 21 CFR 820, ISO 13485, ISO 14971
• Experience with instituting quality controls in an ERP system; SAP preferred
• Strong communication, facilitation and negotiation skills
• Adaptable to fast-paced, dynamic work environment with shifting demands

Responsibilities

• Provide ongoing quality engineering support throughout the product life cycle.
• Support validation planning and transfer activities; determine validation needs.
• Ensure adequacy of non-conformances and CAPA records, investigations, and corrective actions.
• Support risk management activities and ensure validation packages and change orders are complete.
• Become familiar with applicable technology to participate in technical discussions and risk-based decisions.
• Review verification and validation reports and identify GMP gaps.
• Develop and execute strategies to close gaps in a compliant manner.
• Coordinate issue resolution using a risk-based approach.
• Ensure manufacturing processes and validation programs meet FDA and ISO requirements.
• Trend, analyze, and report on quality data to drive product/process improvements.
• Collaborate with cross-functional teams at other Illumina sites.
• Other duties as assigned.

Skills

Quality Assurance

Regulatory Knowledge

Communication

CAPA

Education

Bachelor's Degree

Tools

SAP

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.

This position is responsible for manufacturing and product Quality activities. This role is within Mfg/Ops Quality organization and is accountable for supporting day to day sustaining activities in a manufacturing environment. The position requires exceptional communication, interpersonal, and project management skills to effectively coordinate activities and deliver results.

This position will have direct interaction with Manufacturing and Process Engineering groups to support manufacturing sustaining activities, continuous improvement, and manufacturing capacity expansion. The position may also have quality oversight for more than one manufacturing area. The position will be responsible to support change management activities, Nonconformances, equipment lifecycle, meeting facilitation and other ad hoc sustaining manufacturing requests.

Responsibilities:

• Provide ongoing quality engineering support throughout the product life cycle.
• Provide support to engineering and manufacturing functions for validation planning and transfer activities. Assist teams in determining validation needs and requirements.
• Ensures adequacy of non-conformances and QI/CAPA records, investigations, and corrective actions.
• Support process risk management activities and ensure quality and completeness of validation packages and change orders.
• Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making.
• Review verification and validation reports and identify gaps for GMP compliance.
• Develop and execute strategies to close gaps in an efficient, technical, and compliant manner.
• Coordinate issue resolution using a risk-based approach.
• Ensure manufacturing processes and validation programs meet requirements of FDA and ISO.
• Trend, analyze, and report on quality data in order to improve product and process; develop recommendations based on data analysis.
• Collaborate with counterparts and cross-functional teams at other Illumina sites.
• Other activities as assigned.

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.

Education / Experience:

• Bachelor's Degree required. Engineering and/or Science Degree, preferred
• 0-2 years experience in quality assurance field in a regulated environment; direct experience working in in-vitro diagnostic manufacturing preferred
• Knowledge and experience applying quality regulations and standards (21CFR 820, ISO 13485, ISO 14971, IVDD)
• Knowledge and experience with instituting quality controls in an ERP system, SAP preferred
• Highly effective communication, facilitation and negotiation skills
• Adaptable to fast-paced, dynamic work environment with shifting demands

The estimated base salary range for the Mfg/Ops Quality Engineer 1 role based in the United States of America is: $62,900 - $94,300. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. The range reflects long‑term growth in the role; therefore, most candidates are hired between the minimum and middle of the range. Placement depends on experience, skills, location, and internal equity. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.

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 [e-mail].

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.

This role is not eligible for visa sponsorship.