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.Why You Illumina Laboratory Services are at the forefront of bringing whole genome sequencing into healthcare, helping change lives by driving adoption of sequencing in the diagnosis of rare disease and emerging cancer applications. Your new colleagues are all deeply passionate about what they do, knowing that our work has the power to improve lives. Your passion for Quality oversight and ensuring our products meet the appropriate regulatory requirements means that you understand the value you can bring in a highly innovative companyThe roleAs Sr/Staff Quality Engineer for Illumina Laboratory Services, you will ensure development processes conform to applicable safety and quality system regulations and standards (e.g. ISO 13485, IEC 62304, ISO14971). You will be responsible for guiding teams in execution of development life cycle activities. Your focus will be on laboratory and software product development quality planning and risk management to positively impact the safety and efficacy of our service. You will facilitate teams in identifying, documenting, assessing, correcting and preventing quality issues using risk analysis, root cause analysis tools, from initial concept through transfer to sustaining.This is an exciting opportunity to be part of Illumina’s continued growth. Responsibilities will include, but are not limited toImplement and improve development quality system processes in accordance with safety and quality system regulations and standards.Support cross functional teams to ensure laboratory assays and/or software is developed and maintained in accordance with regulations and internal requirements and procedures.Resolve complex issues in creative and effective ways using professional Quality Management concepts in line with company objectives.Facilitate identification of product risks and risk mitigations for development and change controls.Partner with other functions to drive a culture of Quality.Provide training, guidance and interpretation of quality system processes as needed.Review and approve change control documentation.Participate in non-conformance investigations and ensure CAPA findings, risks, recommendations and outcomes are appropriate and are clearly documented and communicated.Become familiar with the applicable technology to participate in technical discussions and risk-based decision-making.Trend, analyze, and report on quality data in order to improve product and process.Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion.Other such duties that may be determined by Management.Listed responsibilities are essential, but not an exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.Preferred background, skills and experience Working knowledge of design control principles and/or software development life cycle modelsExperience applying quality regulations and standards (ISO 13485, IEC 62304, ISO 15189) and establishing quality systemsExperience in a regulated environment, ideally in vitro diagnostics / medical device or other regulated industryExcellent interpersonal, verbal and written communication skillsExcellent attention to detail, well organized, able to work independently and with a team and provide SME leadershipAbility to operate flexibly in fast-paced environmentIllumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunities 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.
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