Senior Supply Chain Quality Engineer

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 Supply Chain Quality Engineer. This person will be our subject matter expert in Supply Chain Quality with focus on quality oversight for all supply chain aspects including (but not limited to) oversight of QuidelOrtho suppliers as it relates to 3PL, transportation, packaging. The individual will work with minimal supervision as it pertains to day-to-day activities. The position requires a large degree of independent judgement and decision making. The Senior Supply Chain Quality Engineer will be responsible for helping us set up our new NE distribution center.

The role will working out of our Raritan, NJ office in a hybrid schedule with frequent visits to our distribution center in downtown Philadelphia.

The Responsibilities

• Accountable to oversee, coordinate, and execute supply chain activities to ensure flawless execution of processes end to end. The responsibilities include:
• Quality support for outsourced distribution center with control of products/processes from receipt, warehouse storage, packaging, shipping operations, including the review and approval of temperature excursion data impacting temperature-controlled products, cold storage areas and cold chain shipments,
• Creation and maintenance of related procedures, reporting, tracking and analyses of Key Performance Indicators (KPI) for distribution centers and associated supply chain related suppliers (including supporting business reviews for outsourced distribution center),
• Oversee all quality management elements associated with (not limited to) stop-shipment, Non-Conformance, CAPA, Change Control, Quality review and approval, and support as necessary, IQOQPQ activities associated with changes to warehouse storage areas, monitoring equipment, and validated packaging. Support shipping lane validations (inbound and outbound) associated with outsourced distribution center, as necessary.
• Lead and support supply chain quality projects, provide audit support through various roles, promote a risk-based approach and continuous improvements.
• The work shall be performed to ensure compliance with Regulatory requirements (cGMP, cGDP, ISO 9001, ISO 13485, FDA 21 CFR 820, EU Directive 98/79/EC, and 2017/746 regulation).
• Perform supplier management/control activities required for approval and continuous monitoring, including supplier quality oversight business meetings review, inputs and recommendation on periodic supplier assessment/audit.
• Provide audit support during internal and external audits with outsourced distribution centers.
• Training and mentoring stakeholders, peers, and co-workers as it pertains to supplier controls with outsourced distribution centers.
• Perform other work-related duties as assigned.

The Individual

Required:

• Bachelor's degree in Science, Engineering, QA, or other related business field with a minimum of 3 years of supply chain/distribution experience in the medical device, biologics, or pharmaceutical environment is required.
• Broad based technical knowledge and competency within Quality Engineering, Quality Assurance, and Quality Systems allied with a solid working knowledge of supply chain operations in the regulated medical device, pharma sector, or other regulated environment.
• Experience and knowledge associated with specific Quality System Regulations, standards, and directives required including the FDA Quality System Regulation, 21 CFR Part 820, and ISO 13485
• Ability to effectively negotiate and influence external and internal business stakeholders with regards to quality risks.
• Strong analytical, critical, and decision-making skills with an ability to provide risk based approaches and solutions within the boundaries of the quality and compliance environment in which the business operates within.
• Strong conflict resolution and change management skills.
• Strong written and verbal communication skills.
• Strong analytical reasoning skills.
• Demonstrated ability to work in a diverse, cross-functional environment.

Preferred:

• Experience hosting and/or participation in quality management system audits.
• Demonstrated knowledge of business impact of compliance issues and risk management.
• Six Sigma and use of associated tools in every day decision making.
• Risk Management.
• Data analysis and report building using PowerBI (Excel, Minitab, etc).
• Lead Auditor certification.

The Key Working Relationships

Internal Partners:

• Global Supplier Chain Quality, Global Procurement, Global Supply Chain Operations: Ensures overall transparency to quality performance of External Supply Chain 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/3PL: In line with the company's requirements and / or established Quality Agreements ensure partnership with External Partner sites 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.

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 $67,000 to $114,000. 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 .

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