Responsible for supervising a group of engineers for ensuring suppliers deliver quality parts, materials, and services. Qualifies suppliers according to company standards
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Experience contributing to cross-functional product development teams.
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.
Demonstrated experience with data analysis, value stream mapping, 6‐Sigma, and Kaizen events preferred.
Extensive experience with Microsoft Office (Words, Excel, PowerPoint).
Practical experience in FDA and ISO regulated environments is a plus.
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.
Participates in new supplier qualification and audit processes.
Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
Adheres to and may help develop an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
Performs value-engineering to improve existing components and products in cost, technology, quality, health and safety
Point of contact for technical communication with suppliers.
Qualifies new components and ensures Purchase Part Specification release.
Evaluates and manages supplier part process changes (revision, die shrink, fab location, etc.) and end of life notification.
Evaluates alternate sources of supply for improved cost, reduced lead time or risk.
Maintains Approved Vendor List (AVL) to ensure materials meet design requirements.
Helps define and validate quality assurance and quality control processes.
Helps define quality rules, tools and controls for inspection.
Reviews data for and resolve issues concerning incoming, in-process, and final inspection and test activities.
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 failure investigations and failure report writing, inspection, calibration, trend analysis, and supplier/internal auditing
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.
Careful and accurate documentation of work.
Ability to read drawings, schematics, etc.
Ability to perform component testing as required
Working knowledge of AVL, MRP, ISO, FDA, GMP
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.