Staff Design Quality Engineer
Staff Design Quality Engineer
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$ 105600 - 158400
1 Vacancy
Job Description
This position is responsible for supporting activities related to the product/test development and software development and/or implementation of inhouse and thirdparty software systems. The position will be a core member of projects varying in complexity to drive compliance with internal and external procedures and regulations. In this cross functional quality role you will actively participate in product development and transfer activities and internal quality initiatives ensuring product and process conformance to CAP CLIA and ISO 13485 standards. This role will serve as a resource to software development and productdevelopment to improve product quality reliability and process capability. This role will also facilitate teams in identifying documenting assessing correcting and preventing quality issues using risk analysis and root cause analysis tools. The position will be responsible for quality planning and establishing and maintaining metrics to improve quality system processes process capability reliability and quality of products. This role requires strong communication interpersonal and organizational skills and a solid understanding of the application of CAP CLIA FDA and ISO 13485 standards.
Responsibilities
- Provides Quality oversight to ensure Illuminas services and processes are safe effective and meet customer performance needs throughout the product lifecycles
- Provide guidance on implementation and support continuous improvement of our QMS Product development and SDLC activities.
- Provides support for project planning requirements/specifications development verification and validation design transfer process development process validation risk management
- Ensure product development and validation programs meet requirements of CAP CLIA and ISO when applicable
- Leads workflow risk management activities
- Audits the quality and completeness of product Design History Files and supports internal and external audits
- Expertly guide software compliance design control and provide quality leadership to the product development teams to identify compliance gaps and develop and execute strategies to close the gaps in an efficient technical and compliant manner.
- Supports issue resolution using a riskbased approach
- Train mentor software bioinformatics product development and Lab/clinical operations team
- Provides management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion
- Utilizes quality and statistical analysis tools (e.g. SPC Six Sigma Risk Analysis FMEA DOE statistical comparison tests and trend analysis)
- Defines and/or create processes to align with quality standards and business practices
- Mentors lowerlevel Design Quality Engineers to develop skills sets
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:
- Typically requires a minimum of 8 years of related experience with a Bachelors degree; or 6 years and a Masters degree; or a PhD with 3 years of experience; or equivalent experience
- 8 years of related experience
- Quality Certification (e.g. CQE) is preferred
- Technical expertise in products such as reagents consumables assays instruments.
- Applied experience with quality and statistical analysis tools (e.g. SPC Six Sigma Risk Analysis FMEA DOE statistical comparison tests and trend analysis)
- Highly effective communication facilitation coaching and negotiation skills
- Experience applying quality regulations and standards (e.g. CLIA CAP NYDoH ISO 13485 ISO 15189 ISO 14971)
- Adaptable to fastpaced dynamic work environment with shifting demands
- Experience participating in initiatives with strong influencing skills
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 zeronet 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. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local state and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local state and federal laws. If you require accommodation to complete the application or interview process please contact To learn more visit: The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.
Required Experience:
Staff IC
Employment Type
Full-Time
