|at ( view profile)|
|Date Posted||June 25, 2019|
|Address||5602 Research Park Blvd Suite 200|
We are seeking a talented, driven and experienced QMS professional to join our dynamic team. This role will partner cross-functionally to influence and ensure compliance to applicable standards, regulations as well as to the Illumina Quality Management System.
Strong background in Quality Management Systems (emphasis in Nonconforming Product, CAPA and Change Management).
- Nonconforming Product:
- Advise, evaluate, approve and verify non-conforming product and process (NCRs) dispositions meet requirements of the NC process, are correctly documented, implemented and closed in a timely manner
- Advise, evaluate, perform and assist in CAPA process to ensure investigations and implementation of corrections/corrective actions are appropriate, clearly documented and effective
- Audit Program:
- Ability to serve as subject matter expert in support of internal and external audits
- Participate in investigations and ensure audit findings, associated risks, recommendations and outcomes are appropriate, clearly documented and completed in a timely manner
- Quality Management Review:
- Ability to serve as subject matter expert in support Quality Management Review
- Ability to trend, analyze, and report on quality data in order to improve products and processes
- Ability to develop recommendations based on data analysis
- Ensure areas of responsibility meet FDA 21 CFR 820 and ISO 13485 requirements
- Partner cross-functionally in order to ensure awareness and compliance to procedures, specifications, ISO requirements and any applicable regulations
- Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely manner
- Authority to assess and release final product
- Other activities as assigned
- 5+ years’ experience in quality management systems.
- Strong knowledge and experience with quality regulations and standards as well as experience applying them (e.g., 21 CFR 820, ISO 13485, ISO 14971).
- Highly effective communication, facilitation, coaching, and negotiation skills including ability to present and participate in executive presentations.
- Self-starter, strong work ethic, strong organizational skills, critical thinking.
- Excellent attention to detail and accuracy, well organized and able to work independently and in teams.
- Adaptable to fast-paced, dynamic work environment with shifting demands
- Knowledge and skills typically acquired through previous positions in fast-paced corporate environments which involved responsibility for similar work.
- BS/BA or equivalent in Engineering, Biological/Life Sciences, Chemistry or related field required.