Quality Engineer II - Varite, Inc
Rochester, NY 14625
About the Job
Job Description:
Monday - Friday 8:00am - 5:00pm
Position Summary
We are looking for a self-driven, resourceful Quality Assurance Engineer with demonstrated experience driving and sustaining improvement to products while ensuring that those products manufactured meet internal, customer, and regulatory requirements. Under the direction of the Senior Manager, Quality Assurance this position is responsible for executing the Customer Complaint Management process as per the Quality System to ensure that the product or process quality requirements are fulfilled.
Key Responsibilities
Minimum Requirements
Knowledge, Skills, and Abilities
Monday - Friday 8:00am - 5:00pm
Position Summary
We are looking for a self-driven, resourceful Quality Assurance Engineer with demonstrated experience driving and sustaining improvement to products while ensuring that those products manufactured meet internal, customer, and regulatory requirements. Under the direction of the Senior Manager, Quality Assurance this position is responsible for executing the Customer Complaint Management process as per the Quality System to ensure that the product or process quality requirements are fulfilled.
Key Responsibilities
- Interact with Technical Support, Customer Service, Sales Representatives, Product Managers, and/or customers by email, phone, and/ or in-person to ensure that information and samples necessary to investigate a customer complaint are received (and credit or replacement product is issued to a customer for confirmed complaints).
- Interact with Customer Quality team in order to perform an impact assessment (severity, occurrence, and detection) for a complaint; evaluate and understand how complaint samples compare to established specifications; and review data to determine if a complaint is an isolated incident or a systemic issue.
- Lead customer complaint investigations working with cross-functional teams including Quality Assurance, Engineering, Manufacturing, and Research & Development in order to identify the root cause, corrections, and corrective and preventive actions.
- Submit work orders and interact with Quality Control in order to evaluate or understand how complaint samples compare to established specifications.
- Document the root cause, corrections, and corrective and preventive actions in the CAPA System (TrackWise); write a Corrective Action Response (CAR) that contains a summary of the investigation, corrections, and corrective and preventive actions; and utilize the Complaint Management System (SalesForce.com) to both document and communicate the CAR to the customer on behalf of the site.
- Ensure Management is informed in a timely manner of any significant customer complaints.
- Analyze complaint trends and facilitate an investigation, root cause analysis, and the identification of corrective actions for products and processes with a cross-functional teams.
- Support on-site or virtual customer audits as needed.
- Complies with required quality, safety, and operation/distribution quality system documents - such as our quality manual and policy, good documentation practices, plant safety commitments, general safety requirements, personal protective equipment program, and good manufacturing and distribution practices - as applicable.
- Performs other duties as needed.
Minimum Requirements
- At least 2 years' experience in direct Quality Assurance with experiences interfacing with relevant customers. At least 1 year of demonstrated leadership experience (leading projects) is preferred.
- Bachelor's degree in related field, or consideration of an equivalent combination of education and experience. Science or Engineering Degree preferred.
- Working experience in a regulated (FDA Quality System Regulations (21 CFR Part 820)) and certified International Organization for Standardization (ISO) (13485:2016) Quality System.
- Lead Auditor Certification preferred.
Knowledge, Skills, and Abilities
- Strong desire to improve product quality and satisfy customer.
- Ability to multi-task and balance multiple priorities at the same time while focusing and carrying out tasks in a timely and accurate manner.
- Well organized and structured and detail-oriented.
- Ability to work effectively and build and maintain collaborative relationships with individuals and teams across functional boundaries at all levels of the organization.
- Ability to communicate effectively, both verbally and in writing, with internal and external customers; experience interacting with external customers is preferred.
- Ability work on complex issues of moderate scope.
- Working knowledge of quality tools (DMAIC, Risk Management).
- Working knowledge of ERP Systems (SAP and/or E1), Complaint Management System (SalesForce.com), CAPA System (TrackWise), and Document Control System (MasterControl and/or Agile) is preferred.
- Ability to use all of the following PC applications: Microsoft Word, Excel, and PowerPoint.
Source : Varite, Inc