Leads and participate in Supplier Development projects and continuous improvement activities focusing on Supplier quality.
Cascades Global Supplier Quality Strategy and implement processes
Monitors supplier performance and drive improvements in suppliers’ quality metrics.
s and maintains Supplier Audit plan, execute and follow up for closure
And also provides training/oversight of Supplier audit process.
Supports Product/Process Validation and establish quality requirements with supplier to meet Illumina standards and regulations compliance
Supports complaint reduction program with supplier and Ensure scar effectiveness
Manage supplier part process changes (molding, Thermoforming, fab location, etc.) and end of life notification of materials.
Leads Supplier Quality efforts with new product introductions, cost reduction projects and part sourcing activities.
Work closely with Cross functional team to ensure all specifications are developed, reviews, approved and adhered to.
Provide leadership for Supplier Quality Engineers working closely with Cross function team to ensure company maintains high quality suppliers and to provide appropriate feedback to suppliers.
Mentors direct reports, leads and trains employees.
Responsible for day-to-day quality management, Supplier evaluation/audits, corrective actions, NPI and metric reporting.
Proactively looks for opportunities to identify changes, increase efficiency, influence decision and deliver results while ensuring compliance.
Experience with Quality, Project Management, and Process Engineering methodologies and tools.
Demonstrated capability in successfully managing and leading change.
Practice identifying, mitigating, and resolving risks.
Ability to work effectively in a fast-paced, dynamic environment with shifting and competing priorities.
Exceptional communication skills, both written and verbal, including executive presentations.
Ability to travel as needed.
Ensures quality is maintained following standard practices and procedures, participates in identifying new technologies and processes, may lead small project group.
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.
7+ years’ experience in quality assurance field with emphasis on medical devices or life sciences.
Strong experience with Supplier Audits, SCAR process including failure investigations, part / new material qualitification, inspection, calibration, trend analysis of Supplier faults and corrective actions etc.
Excellent written and oral communication skills
Excellent problem solving and analytical skills.
Effective interpersonal and communication skills and capable of supporting cross-functional project goals.
Practical experience in FDA and ISO regulated environment.
Knowledge and skills typically acquired through previous positions in fast-paced corporate environments which involved responsibility for similar work.
B.S. or equivalent in Engineering or related field required.
Graduate degree preferred.
ASQ or similar certification preferred
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