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.
Responsibilities:
Drive staff results by communicating job expectations, planning, monitoring and appraising job results, coaching and counseling employees, recognizing performance issues and driving improvement, developing, coordinating and enforcing systems, policies, procedures and productivity standards
Establish strategic goals by gathering pertinent business, financial, service and operations information, choosing a course of action, defining objectives, and evaluating outcomes
Maintain staff by recruiting, selecting, orienting and training employees; maintaining a safe, secure and legal work environment; developing personal growth opportunities
Ensure validation program meets requirements of FDA (21 CFR Part 11 and Part 820), ISO 9001/13485, IEC 62304 and MDSAP
Identify differences between ISO and FDA requirements and their applicability to products targeting different markets
Report broadly through the organization on validation activities and instrument manufacturing audit readiness
Estimate timelines and budgeting for validation engineering development efforts
Formalize, standardize and document processes
Assist development and manufacturing engineering in designing, performing, and improving verification tests
Participate as an active member on new product development teams
Interact with cross-disciplinary project teams in order to meet project milestones and end goals
Work with scientists, technicians, engineers, marketing, and project management to deliver commercial and internal genetic analysis systems
May lead cross-functional teams to address system issues
Requirements:
5-7 years managing a mid-size (6-10 FTE) team with demonstrated ability to coach, mentor, develop and discipline
Experience in the medical device/IVD industry in the development and deployment of Quality Systems, process controls, and continuous improvement methods
Experience in both front room and back room audit support
5-7 years experience in manufacturing, quality assurance or engineering in an FDA regulated environment
Knowledge and working application of FDA (21 CFR Part 11 and Part 820), ISO 9001/13485, IEC 62304 and MDSAP requirements
Knowledge and working application of Validation Principles, guidelines and industry practice
Proven ability to lead in a continuous improvement environment, identify the end state and lay out a step-by-step plan for attainment while messaging broadly achievable timelines
Knowledge and working application of FMEA and Risk Analysis
Demonstrated strong analytical problem solving (CAPA)
Solid understanding of manufacturing processes in medical device manufacturing
Strong verbal and written communication skills are required
Experience supporting the transition of an RUO manufacturing line to Dx/IVD control a strong plus
Experience with statistics, Statistical Process Control and DOE techniques is a plus
The ability to discuss technical topics with non-technical people is strongly desired
Six Sigma Black Belt certification, PMP certification, ASQ accreditations a plus
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.
The estimated base salary range for the Sr Manager Design and Construction role…