Senior Supplier Quality Engineer

The Opportunity

QuidelOrtho 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 Role

As 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 Individual

Required:

• 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) – Domestic

Preferred:

• 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 Relationships

Internal 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:

• Suppliers: Develop relationship with vendors to monitor and improve quality performance.

The Work Environment

The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Up to 75% of the time at desk, standing or sitting extended periods of time. Flexible work hours to meet project deadlines.4

Physical Demands

Works for lengthy periods of time in sitting or standing position and for lengthy periods of time using a computer. Position may require travel, up to 10%, travel includes airplane, automobile travel and overnight hotel. At times, this role demands flexible work hours to meet deadlines, maintain system availability and support business continuity.

Salary Transparency

The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $90,000-$120,000 [and is bonus eligible or eligible for incentive compensation.] QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

Equal Opportunity

QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at [email protected].