This position is responsible for manufacturing and product Quality activities. This role is within Mfg/Ops Quality organization and is accountable for driving change, establishing sustainable processes, improving products, and providing senior management with actionable process and product data. The position requires exceptional communication, interpersonal and project management skills to effectively coordinate activities and deliver results. A solid understanding of the application of quality regulations and standards (21CFR 820, ISO 13485, ISO 14971, IVDD, MDD) is required.
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 responsibility for new product introduction (NPI) quality oversight for more than one manufacturing area. The position will be responsible to lead risk management activities and support 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.
Provide quality leadership to new product development teams in the areas of design control, design verification and validation, design transfer, process validation, 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
Ensures adequacy of complaint, non-conformances and CAPA records, investigations, and corrective actions
Ensure manufacturing processes and validation programs meet requirements of FDA and ISO.
Aides in the assessment and qualification of new supplier materials such as component specifications and inspection standards
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.
Drive product risk management activities and ensure quality and completeness of project design history files, 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
Identify areas and opportunities to improve quality system processes
Ensure product development 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
Supports department's SCARs
Track and trend supplier performance and recommend appropriate actions
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
A minimum of 5 to 6 years of applied experience in the quality assurance field in a regulated environment; direct experience working in in-vitro diagnostic development and/or manufacturing.
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.
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.
Applied experience in meeting and applying quality regulations and standards (21CFR 820, ISO 13485, ISO 14971, MDD, IVDD, and CMDR).
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.
Background in oligonucleotide synthesis and surface activation chemistry 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.
Bachelor's degree in an engineering or scientific discipline.
Graduate degree in an engineering or scientific discipline and/or business is preferred.
Quality and/or Regulatory Affairs certification desirable (e.g. CQM, CQE, CQA, RAC).
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