Senior Quality Engineer

Description:

As we continue to grow as QuidelOrtho, we are seeking a Senior Quality Engineer, External Manufacturing - Quality & Design Quality (EMQ/DQ). Responsible for executing all aspects of Quality and Compliance between QuidelOrtho and the External Manufacturing Supplier and for executing design control elements according to the requirements of product design procedures.

They are contributors and work independently on day-to-day activities under general direction from the manager and/or designated personnel. The position requires a large degree of independent judgement and decision making within the established policies and procedures for supplier quality and design control. They are able to effectively prioritize a diverse scope of projects requiring analyses and review of data to meet project aims.

The Senior Quality Engineer, EMQ/DQ will provide quality review / approval to supplier change requests and production part approval process (PPAP). They will provide quality review / approval to changes to design. This includes risk management activities, product design requirement updates, product validation, Design History File updates, technical file updates, design reviews and design file audits as needed.

The Senior Quality Engineer, EMQ/DQ assists with investigation, analysis and resolution on quality events including non-conformance, product disposition, root cause investigation and CAPA for External Manufacturing Suppliers to ensure compliance with specifications and requirements. Identify and collaborate to drive implementation of improvement opportunities.

The Senior Quality Engineer, EMQ/DQ utilizes key Quality Engineering (QE) principles, tools, and practices in the role. Must have a good appreciation of both the business needs and end customer requirements. The work shall be performed to ensure compliance with Company and Regulatory requirements (cGMP, cGDP, ISO 9001, ISO 13485, FDA 21 CFR 820, EU Directive 98/79/EC, 2017/745 regulations).

This position can be located as Remote, Rochester, NY, or Raritan, NJ.

The Responsibilities
 

• Collaborate with stakeholders to effectively deliver change management from QuidelOrtho to suppliers and from suppliers to QuidelOrtho, including temporary changes (variances).
• Ensures design and manufacturing process changes are identified and follow QuidelOrtho's change processes, including requirements for validation and are aligned with the production parts approval process (PPAP). This may include training to assist stakeholders with processes.
• Uses expertise to identify opportunities and deliver improvements within the supplier management processes. This may include audit of suppliers.
• Execution of quality management system activities to ensure to ensure department compliance including (but not limited to): document control, training, Non-conformance, RCI, CAPA, Change control support for internal and external audits.
• Maintain compliance readiness of records generated to support projects. Act as SME during audits of QuidelOrtho.
• Performs other work-related duties as assigned.
   

The Individual

Required
 

• Bachelor’s degree or equivalent is required. Related science, engineering or supply chain field of study is preferred.
• 5 - 7 years of experience in quality-related methods and techniques, including supplier quality and design control terminology, quality management principles and quality management tools and their applications.
• Ability to work in a fast-paced environment with multiple, concurrent priorities with many needing immediate resolution and adopting a sense of urgency accordingly, while maintaining a focus on customer satisfaction.
• Good written and oral communication skills.
• Ability to use PC's and associated Microsoft software.