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Staff, Quality Control Engineer

Company: Illumina
Location: San Diego
Posted on: May 15, 2022

Job Description:

We are looking for a driven and talented Staff QC Engineer to join our QC Technical Operations (QCTO) group supporting Reagent Quality Control. This team provides technical expertise to the Reagent QC manufacturing team in the areas of assay transfer, implementation, and troubleshooting, technical product performance investigations, process improvement, and collaboration with the manufacturing team to implement strategic initiatives. The candidate must be able to deliver multiple programs in parallel and under aggressive timelines. This position will be a key business partner in managing the quality and manufacturing relationship, which includes auditing, guidance on gap/risk closure, and meeting business and regulatory obligations with a high degree of integrity. The ideal candidate will have experience with and knowledge of Illumina Assays and sequencing technology.Responsibilities:Identify and drive the development and implementation of activities/methods to improve first pass yield to support operational objectives.Developing and validating testing methodology. Setup, revising and updating Standard Operating Procedures, system or processes to improve material/process specifications/test methodology.Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data.Assignments include areas such as leading product transfer, troubleshooting, nonconformance evaluation, product release improvement, complaint handling investigations, CAPA, material control, process & system enhancement and drive sustaining activities to meet QC goals, etcAssignment may include but not limited to evaluation of non-conformance material, method improvement to incoming and outgoing inspection, calibration, analytical or bio-molecular QC assays to support release, characterization and stability testing of raw materials, production intermediates and final goods etc.Works on problems of diverse scope where analysis of data requires review and interpretation of identifiable factors.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.Promote and execute quality standards, inspection processes, test methodology, quality plans, documents and reports.May provides leadership and mentor junior staff to resolve routine issues.Review procedures and processes and work closely with key internal partners to provide recommendations for improvements.Develop procedures, work instructions, guidance, best practice protocol such as checklists and troubleshooting guidelines.Compiles and writes training material and conducts training sessions on quality control activities.Ensure that the lab processes are compliant with Quality System and EHS requirements.Demonstrates solid judgment in selecting methods and techniques for obtaining solutions.Other such duties that may be determined by Management.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.Requirements:Experience with QC processes and application of various biochemical assays or analytical toolsExperience with Illumina assays or similar DNA library preparation and sequencing technology is desired.Good understanding of FDA regulatory environment (CFR 820), 501k and ISO 13485 strongly preferred.Experience in medical device/ pharmaceutical/ IVD is preferred.Experience in supporting manufacturing operations, or QC/QA operations. Individual with CQE is a plus.Experience with data mining, trend analysis, control charting, statistical analysisDemonstrate leadership as a change agent.May have experience with leading method development/NPI transfer projects independentlyAbility to apply experience in meeting requirement of FDA Quality /System Regulations and/ or ISO 13485 Standard.Able to interpret engineering drawing for mechanical commodity - hardware, metal and plastic parts.Demonstrate critical path thinking and ability to breakdown scientific issues to draw experiment designEffective failure investigation, technical report writing, data mining, trend analysis, statistical analysis.Intermediate to advanced experience with words processing and spreadsheets, charting, graphing tools and presentation tools.May have experience with electronic production life (PLM), enterprise resource planning tools (SAP) and etc.May have experience with statistical analysis packages, eg, JMP, minitab.Must be detailed oriented, well organized and able to work independently and in teams.Highly effective planning, prioritization, organization, and implementation skillsIntermediate to advanced level of knowledge in GD, QC Tool, FMEA, Cpk, Gauge RAbility to identify areas of improvement and devise, plan and implement solutions.Developing project management skillsEstablishes working relationships across functions. Employs internal working relationships to influence business objectivesAbility to design and deliver training to others with regard to work processes and/or quality system elements.Knowledge and skills typically acquired through previous positions in fast-paced corporate environments which involved responsibility for similar work.All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.Education:PhD/MS degree with at least 5 years of related experience, or BS degree with at least 7 years of related experienceField of study in Organic Chemistry, Chemistry, Molecular Biology, Biochemistry, Chemical Engineering, Biochemical Engineering or similar discipline preferredConcerns 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

Keywords: Illumina, San Diego , Staff, Quality Control Engineer, Engineering , San Diego, California

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