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Senior Supplier Quality Engineer - Raritan New Jersey
Company: QuidelOrtho
Location: Raritan, New Jersey
Posted On: 01/21/2025
The OpportunityQuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic.Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.The RoleAs we continue to grow as QuidelOrtho, we are seeking a Senior Supplier Quality Engineer. The Senior Supplier Quality Engineer is responsible for executing all aspects of Quality and Compliance oversight between Ortho and the Supplier (direct and indirect). This person will be an individual contributor and will work independently on day-to-day activities under general direction from manager and/or designated personnel. The position requires a large degree of independent judgement and decision making within the established policies and procedures. This person will be able to work on problems/issues of diverse scope, where analyses of data require evaluation of identifiable factors, develop and implement solutions. Must have a very good appreciation of both business needs and customers' requirements.The Senior Supplier Quality Engineer will coordinate activities associated with the supplier management processes, including suppliers on boarding, supplier change notifications, and decommissioning. In addition, this role will also support Manufacturing Quality Engineers if a need exists. Mentor and train peers and junior staff. Provide audit support if needed. They develop and maintain effective working relationships with Ortho stakeholders and focus suppliers to deliver customer improvements for Ortho. They collaborate across Ortho to identify and prioritize opportunities. Work shall be performed in accordance with the Ortho Leadership attributes.This position will be onsite, full-time at our Raritan, New Jersey site.The Responsibilities - Provide Quality input to non-conformances and product dispositions as they relate to Direct and Indirect suppliers including data analysis for potential trends. Ensure that robust investigations are performed by suppliers in a timely manner, providing strategic direction for investigations, including identification of CAPA.
- Implement appropriate controls around on boarding suppliers and supplier change notifications. Work will require collaboration with stakeholders to effectively deliver change management from Ortho to suppliers and from suppliers to Ortho. Ensures changes are identified and follow Ortho's change processes, including requirements for validation and preparation / review of Failure Modes and Effects Analysis.
- Identify opportunities and deliver improvements within the supplier management processes. This may include audit of suppliers.
- Maintain compliance readiness as it pertains to supplier management. Provide support in coordinating the preparation. May provide audit support through various roles such as Subject matter expert. The work shall be performed to ensure compliance with Regulatory requirements (cGMP, cGDP, ISO9001, ISO13485, 21 CFR 820, Directive 98/79/EC, upcoming 2017/745 regulations and aligned with the Ortho Leadership Attributes. The work shall be performed to ensure compliance with Regulatory requirements (cGMP, cGDP, ISO9001, ISO13485, 21 CFR 820, Directive 98/79/EC, upcoming 2017/745 regulations).
- Perform other work-related duties as assigned.The IndividualRequired:
- Bachelor's Degree in any discipline is required; degree in a related science, engineering or supply chain field of study is preferred.
- 4+ years of of related work experience in Quality is required. Experience in a highly regulated manufacturing environment (Diagnostics, Medical Device, Pharmaceutical or Consumer) is preferred, but not required.
- Knowledge and skills in quality-related methods and techniques, including quality terminology, quality management principles and quality management tools and their applications is required.
- 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.
- Strong working knowledge of applicable regulations (FDA CFR Part 820, Part 11 regulations, and ISO 13485 standards) is preferred.
- Validation experience is preferred.
- Ability to solve complex problems, make risk-based decisions and navigate through ambiguity is preferred.
- Up to 10% travel (as needed) - DomesticPreferred:
- Strong working knowledge of applicable regulations (FDA CFR Part 820, Part 11 regulations, and ISO 13485 standards) is preferred.
- Validation experience if preferred.
- Ability to solve complex problems, make risk-based decisions and navigate through ambiguity.The Key Working RelationshipsInternal Partners:
- Supply Chain, Supplier Quality, Ext Ops, Strategic sourcing and procurement, Global Supply Chain Operations: Ensures overall transparency to quality performance of External partner organizations. Collaborates to implement changes and improvements in quality, cost and delivery. QRC organization: Supports Inspection Readiness and ensures Supplier Management Processes are compliant to Quality Systems Regulations.External Partners:
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