Mfg/Ops Quality Engineer 1 or 2 at Illumina, Inc. in San Diego, California

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.

Position Summary:

This position is responsible for manufacturing and product quality activities. This role is within the Mfg/Ops Quality organization and is accountable for driving change, establishing sustainable processes, improving products, and providing actionable process and product data. The position requires strong communication, interpersonal, and project management skills to effectively coordinate activities and deliver results. A basic understanding of the application of quality regulations and standards (21CFR 820, ISO 13485, ISO 14971, IVDD, MDD) is preferred.

This position will have direct interaction with Reagent Manufacturing and Process Engineering groups to support manufacturing sustaining activities, continuous improvement, and manufacturing capacity expansion. The position may also have responsibility for new product introduction (NPI) quality oversight for more than one manufacturing area. The position may be responsible to support risk management activities and development of process/product validation strategies during technology transfer of new product to the sustaining team. This position will also participate in the sharing of best practices and lessons learned from NPI and Sustaining Quality.

Responsibilities:

• Provide quality leadership to capacity expansion and new product development teams in the areas of process control, process verification and validation, design transfer, risk management, and specification development.


• Provide ongoing quality engineering support throughout the product life cycle.


• Provide support to development, engineering, and manufacturing functions for validation planning and transfer activities. Assist teams in determining validation needs and requirements.


• Ensure adequacy of complaint, non-conformances and CAPA records, investigations, and corrective actions.


• Support process risk management activities and ensure quality and completeness of validation packages, and change orders.


• Provide consultation to end users and process owners with regard to data collection, analysis and creation of validation reports.


• 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.


• Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion.


• Collaborate with the procurement, purchasing, and product design groups to assure compliance/quality of new vendors/materials.


• Collaborate with counterparts and cross-functional teams at other Illumina sites.


• Other activities as assigned.

Requirements:

• A minimum of 1 to 4 years of applied experience in the quality assurance field in a regulated environment but open to considering broader years of experience; direct experience working in in-vitro diagnostic development and/or manufacturing is desirable.


• Strong communication, facilitation, planning, problem-solving, and organizational skills.


• Demonstrated effective project management skills and collaboration on teams in multiple/global locations is desired.


• Demonstrated ability or aptitude to learn how to manage and lead change.


• Good judgment and decision-making skills; knows how to make trade-off decisions while balancing compliance and business impact.


• Experience with quality and process improvement methodologies and tools desired.


• Flexible, with ability to work effectively in a fast-paced, dynamic environment with shifting and competing demands.


• Ability to execute strategy, approach, methods and actions on new assignments.


• Is considered a subject matter expert for assessing and resolving complex quality issues.


• Knowledge in meeting and applying quality regulations and standards (21CFR 820, ISO 13485, ISO 14971, MDD, IVDD, and CMDR) desired.


• Effective data mining, trend analysis, statistical analysis.


• Experience with electronic product life cycle (PLM), enterprise resource planning tools (ERP), manufacturing execution systems (MES).


• Experience with enterprise Quality System tools (e.g., electronic CAPA, Complaint Management systems).


• Background in chemistry, biochemistry or a related engineering discipline is preferred.

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.

Experience/Education:

• Bachelor's degree in an engineering or scientific discipline.


• Work experience in a quality engineering role desirable.

Concerns regarding COVID-19 continue as positive cases are experienced in the communities in which we operate. Please be aware that, as a condition of employment, Illumina may require proof of COVID vaccination in accordance with local statutory requirements (subject to limited exceptions) beginning November 1, 2021.

At Illumina, we strive to foster a diverse and inclusive workplace by cultivating an environment in which everyone contributes to our mission. Built on a strong foundation, Illumina has always been rooted in openness, collaboration, and seeking alternative views and 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 demonstrate our collective commitment to diversity and inclusion in the communities we live and work. 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. 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