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Quality Engineer

Company: Repligen Corporation
Location: Stratford
Posted on: January 16, 2022

Job Description:

The Quality Engineer will report directly into the QA Manager or Director.
This position is responsible to actively participate in the Repligen ISO 9001 Quality Management System. This role is responsible for providing support and investigation of customer complaints for commercial products and supporting continuous improvement of commercial products.
This position will participate in receiving, reviewing, and processing product and customer complaint handling and risk management, as well as additional departmental support.

Responsibilities:
--- Interface with customers regarding the details and documentation of complaint records, investigation, and risk management
--- Responsible for collecting data related to product complaints and entering collected information into the complaint management system
--- Immediately notify senior management of Complaint Management issues that suggest a potential regulatory or business risk
--- Request and document any additional information needed to thoroughly evaluate and investigate the complaint, including coordinating the procurement of complaint samples
--- Send written or electronic acknowledgement of the complaint to the customer
--- Document all contact with complainants in the system
--- Manage workload to ensure complaint completion within targeted turn around time
--- Ability to establish rapport with internal/external customers, peers, and employees in all departments
--- Support activities and documentation related to corrections, corrective actions and preventive actions to correct and eliminate the potential for non-conformances
--- Works constructively with cross-functional departments for timely resolution of quality issues
Qualifications/Skills
--- BA/BS degree (in a Biological Science, Engineering, or Physical Science requires).
--- Experience with stainless steel and plastic device, systems/software and consumable products and associated manufacturing processes.
--- Minimum 2-4 years working in a regulated environment, preferably in Bioprocessing
--- Experience with Quality Management System (ISO 9001)
--- Customer service/complaint handling and problem-solving skill
--- Basic computer skills (i.e. Microsoft Office - word processing, spreadsheets, databases); SalesForce, Canea One experience preferred
--- Documentation, negotiation, time management, and communication skills (both written and verbal)
--- Reasoning ability, support and prioritize projects, adapt to shifting priorities, work with minimal supervision, able to resolve problems/conflicts
--- Must be extremely detail-oriented
Certified Six Sigma Green Belt

Keywords: Repligen Corporation, Visalia , Quality Engineer, Engineering , Stratford, California

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