In this role you will support Quality System audits and process improvements, ensuring compliance to ISO, MDSAP, FDA and equivalent global regulations and conformance with international standards as part of a highly innovative business model. You will be responsible for monitoring compliance to company policies and procedures and partnering with teams to identify and resolve quality issues using risk analysis and root cause analysis tools. This role requires strong auditing, communication, interpersonal and organizational skills and a solid understanding of the application of FDA and ISO 13485 standards.
Job Duties:
Supports audit team and provides quality systems oversight, and strategic guidance to drive global compliance audits and develop/improve processes and procedures
Supports Global internal quality system audit program, may include travel to other sites
Supports with global site leads to optimize the quality audit program to meet 6+ regulatory regions (US, EU, Canada, Australia, Brazil, Japan, etc.)
Enable ISO 13485:2016 transition and support ILMN geographical expansions
Identifies, assesses, resolves, and where needed, escalates potential compliance and/or product quality risks
Ensures audit findings and risks are clearly communicated; and corrections and CAPAs are appropriate to risk level
Trends, analyzes, global audit data; and reports on analysis, makes recommendations, and drives programs to improve products and processes
Helps to resolve complex non-compliant issues by the most efficient and effective methods
Supports quality system due diligence and integration activities as required by the business
Supports foundational quality appraisals and improvement related to Voluntary Improvement Program
Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Advises and consults on project/quality plans, risk assessments and remediation plans
Identifies, designs, and delivers training programs to drive a quality culture
Supports internal and third-party (FDA, Notified Body, Customer) quality system audit activities (schedule, plan, perform, CAPA follow up)
Other activities as assigned
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
General skills:
Strong communication, facilitation, planning, problem-solving and organizational skills
Strong influencing and negotiation skills
Demonstrated effective project management in multiple/global locations is desired
Demonstrated capability in successfully managing and leading change
Demonstrated knowledge of business impact of compliance issues and risk management is preferred
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 effectively identify content, design and deliver training about work processes and/or quality system elements
Independence level:
Determines strategy, approach, methods and actions on new assignments. Typically, will coordinate and lead some activities of other personnel.
Is considered an escalation resource and subject matter expert for assessing and resolving complex issues.
Operates with high level of independence to investigate and resolve issues, lead projects, plan and implement improvements, and achieve goals.
Reports directly to the Sr Manager, Global Quality Audits and Compliance.
Technical skills:
Applied experience in meeting and applying quality regulations and standards (21CFR 820, ISO 13485, ISO 14971, MDSAP, IVDR, MDR)
Broad based technical knowledge and skills in business areas such as Quality Engineering, Quality Assurance, Quality Systems, Supplier Quality, Regulatory and Quality Compliance, preferred
Effective data mining, trend analysis, statistical analysis, preferred
Intermediate to advanced experience with word processing and spreadsheets.
Intermediate to advanced experience with charting and graphing tools
Intermediate to advanced experience with presentation tools (Visio, MS Project)
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)
Education/Experience:
BS or equivalent in an engineering, life science or quality discipline; advanced degree preferred.
A minimum of 2 years of experience in quality assurance field in a regulated environment; direct experience working in in-vitro diagnostic development and/or manufacturing preferred
Concerns regarding COVID-19 continue as positive cases are experienced in the communities in which we operate. Please be aware that, as a condition of employment, Illumina requires proof of COVID vaccination for all U.S.-based employees (subject to limited exceptions) beginning November 1, 2021.
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 zero-net 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. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
