Design Quality Manager - Sequencing Systems

Illumina San Diego , CA 92140

Posted 4 months ago

Position Summary:

The 'Design Quality Engineering (DQE) Manager Sequencing Systems' leads a team of Design Quality Engineers that support Illumina's Platform Development teams to ensure that all In Vitro Diagnostic (IVD) and Research Use Only (RUO) products are designed and manufactured in accordance with company policies and procedures governing Design Control, Risk Management, and Production/Process controls. As a trusted leader, they will facilitate communication and coordination between project teams, functional departments, and senior staff while also playing a key role in leading improvement opportunities within the NPI elements of Illumina's quality system. This role also will be allocated as a resource in some percentage to support one or more new product development programs, depending on the project's scope.

Responsibilities:

Product Development Support:

  • Advise Design Quality Engineers to act as trusted advisors and as project core team members communicate and pull in other Quality groups proactively as needed

  • Devise strategic and operational solutions to complex "gray areas" associated with product quality, business/program success, and compliance risk across multiple programs

  • Ensure Design Control is achieved across multiple programs (User Need, Design Inputs/Subsystem Requirements, Design Outputs, Design Verification, Design Validation)

  • Ensure your team appropriately Plans, Facilitates, & Reports Risk Management activities (ISO 14971) across multiple programs

  • Ensure Production & Process Controls such as measurement system analysis, test method validation, & process validation (IQ, OQ, PQ) are successfully executed across multiple programs and their manufacturing processes

  • Contribute quality and compliance expertise and guidance to teams responsible for addressing specific quality issues that arise in development

Leadership:

  • Provide leadership, oversight, and strategic guidance to drive initiatives and identify opportunities to improve procedures and business processes.

  • Performance Management of direct reports

  • Accountable for driving measurable improvements to employee engagement on their team

  • Develop talent on your team to be effective Design Quality Engineers

  • Recruit high performing talent to join the Design Quality team, growing the organization as required to accommodate resource demand

  • Project assignment and resource tracking

  • Partner with fellow team managers to drive collaboration and synergy

Quality System Support:

  • Support global quality initiatives and ensure that required activities are carried out, including pertinent personnel planning, training and resourcing

  • As appropriate for regulated products, ensure tactical readiness in response to on-site visits and inspections by regulatory agencies, certification associations and customers

  • Provide subject matter expertise during internal and external quality system audits

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:

  • 7+ year's experience in quality engineering role in a Medical Device or In Vitro Diagnostic design and/or manufacturing environment

  • 1-2+ year's experience leading people

  • Demonstrated experience with product development processes- particularly design controls, risk management (ISO 14971), and production/process controls

  • Working knowledge of the FDA medical device Quality Systems Regulations. Prefer a solid understanding of the application of quality regulations and standards (21CFR 820, ISO 13485:2016, ISO 14971, IVDD, IVDR, MDD).

  • Experience with development and manufacturing of electrical/mechanical/software/chemical systems is preferred

  • Must have capability to review, analyze, summarize and interpret quality systems data, draw conclusions, make appropriate decisions and recommendations, write concise and accurate reports and give oral presentations

  • Strong leadership skills with demonstrated ability to effectively work across teams and functions

  • Proven capacity to effectively manage and escalate program risks

  • Excellent organizational skills required and able to work in a cross-functional team

  • Occasional international travel may be required

Education:

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

  • Graduate degree in an engineering or scientific discipline and/or business a plus;

  • ASQ certification a plus

Illumina believes that everyone has the ability to make an impact, and 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 have a disability or special need that requires accommodation, please contact us at applications@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf


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Design Quality Manager - Sequencing Systems

Illumina