- Bachelor of Science
- Bachelor's degree
- Certified Quality Auditor
- Communication skills
- Certified Quality Engineer
- QA/QC
- Computer skills
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Main Responsibilities
Consults to ensure that high quality products are designed, engineered, and manufactured by Agilent’s PLXB Cell Analysis Division, in conformance with customer requirements, required standards and regulations. Monitors the Customer Experience and ensures continuous improvements are made to meet or exceed customers’ expectations.
Position Details:
Generate and communicate Customer Experience metrics and ensure actions are in place to address opportunities. Lead or support continuous improvement activities.
Develop and implement quality initiatives to improve the organization’s core business processes and to influence the development of a customer-centered organization.
Provide expertise, training and/or consulting in Quality processes and methods to build and maintain a customer-oriented quality culture.
Contributes to the development and implementation of product test plans including Verification and Validation of products and processes.
Performs standard quality engineering reviews of design documentation for compliance with stated requirements, including supplier quality and company quality records.
Assists in the resolution of supplier quality issues.
Provides support with investigations and determination of root cause for consumer complaints and product failures.
Works closely with RA/QA, Engineering, Manufacturing and other functional areas to evaluate actual or potential failures.
Maintains and updates risk management files as needed.
Participates and supports internal and external supplier audits and regulatory inspections.
Monitors and advises on how product quality is performing and publishes data and reports regarding the effectiveness of the quality management system.
Participates as needed in remediating non conformances, driving timely disposition and closure, identifies nonconformance trends and develops and/or administers technical investigations and corrective action programs to resolve quality problems.
Education and Experience
BA/BS in Life Sciences, or other technical field
Minimum 5 years QA/QC or related experience in the medical device industry.
Experience with CAPA, complaint investigation, field action processes and risk management
Experience with designing and/or implementing test plans (preferred)
Quality Engineer experience (preferred)
Internal and external (e.g. FDA, Notified Body, Supplier) audit participation
Skills/Requirements
Familiarity / experience with Industry-Accepted compliance test standards (e.g. UL, CSA, Safety, EMC) preferred
Excellent verbal/written communication, interpersonal and computer skills (required)
Strong organizational and time management skills
Ability to communicate, collaborate and lead cross-functionally to resolve issues, including with customers (required)
Experience in Quality and/or Reliability Engineering or experience utilizing Quality tools and practices strongly preferred.
CQE, CQA (preferred)
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