Ultimate
Senior Quality Assurance Engineer (CAPA/NC/Medical)
At a glance
Location: US-NJ-Mahwah Map
Posted: 09/11/2020
Closing: 10/10/2020
Degree: Not Specified
Type: Contractor
Experience: Not Specified
Ultimate
Job description

Job Summary:
Will work within the quality operations team, under minimal supervision, with responsibility for quality related activities

Essential Duties and Responsibilities:
  • Work closely with operations and the business functions to ensure quality performance of product and processes.
  • Oversight and approval of NC & CAPA, activist and mentor in problem solving and root causing activities.
  • Lead and participate in the development and improvement of the manufacturing processes for existing and new products.
  • Analysis and review of concession requests.
  • Review and approval of change management activities.
  • Maintain KPI for monitoring of process quality, perform analysis and interpret trends, take action as necessary.
  • Support execution and analysis of QATs.
  • Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.
  • Proficient in risk management practices and tools, having high expertise in process risk.
  • Develop and provide input for risk management by identifying opportunities and weaknesses.
  • Proficiency in and makes continuous strides towards optimization of inspection methods and sampling. Support First Article Inspections.
  • Proficiency in statistical methods and application.
  • Participate and interface in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise.
  • Assist in the development, responsible for review & approval of process and equipment validation/qualification.
  • Support manufacturing transfers to other plants/facilities, leading quality activities.
  • Responsible for initiation, management and support of Ship, Product Holds, potential product escapes.
  • Coach and mentor others in quality topics and activities.

Benefits:
We put our Ambassadors first. When it comes down to it, we know we can't fulfill our Promise to our business customers without your commitment. You represent our organization while on assignment. In return, we do our best to show our commitment to you. Our Ambassador Benefits package includes: Medical, dental and vision coverage. It also includes 401k, sick time, holiday and much more. We are an equal opportunity employer

We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
Senior Quality Assurance Engineer (CAPA/NC/Medical)