Senior Supplier Quality Engineer (Summers Ridge - HQ)

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 to support Quality Operations. The Supplier Quality Engineer (SQE) is responsible for ensuring that the products, services, and materials received from suppliers meet the company's quality standards and regulatory requirements. The SQE interacts and collaborates with the Company's suppliers to resolve quality issues, conduct supplier audits, and continuously improve supplier quality performance. This position maintains and improves the Company's Supplier Management System which includes supplier corrective action process and scorecards. The SQE leads complex root cause failure investigations and troubleshooting of customer complaints and product nonconformances within manufacturing related to suppliers. This position will also support incoming inspection in a technical capacity related to inspections. Works closely with internal departments such as procurement, engineering, and manufacturing - acting as the champion of Quality System compliance - to drive quality improvements and support the overall supply chain strategy.

This position will be working in a hybrid schedule (2-3 days onsite) at our Summer Ridge office - San Diego, CA with domestic travel up to 25-30% annually.

The Responsibilities

• Evaluates suppliers for technical capability and quality system performance to on-board and subsequently maintain those supplier relationships. Leads and positively influences product improvements of supplied products through effective use of the Company's quality system.
• Leads the site effort in managing the nonconforming material functions through effective identification, segregation, technical root cause failure analysis and disposition of material - resulting in sound corrective action at the supplier site to prevent reoccurrence. (SCAR System Administration)
• Actively reviews existing Raw Material Specifications, supplier capability, and the corresponding Receiving Inspection Instructions for accuracy and applicability.
• Supports (including leading as needed) root cause failure investigation activities and the subsequent writing, editing, and/or approval of investigation reports related to suppliers.
• Participates in Complaint Committee meetings and present investigation findings to peers and management.
• Represents the Quality Control department from a supplier perspective in evaluating failures, performing technical root cause analysis and developing and executing corrective and preventive actions.
• Performs statistical analysis of supplier performance data, data from experiments and manufacturing process trend monitoring to serve as inputs into supplier performance monitoring and scorecards.
• Attends and actively participates in Management Review Board and presents findings and recommendations.
• Perform other work-related duties as assigned.

The Individual

Required:

• B.S. in Engineering/Chemistry/Biology/Technical Discipline or equivalent combination of certification and work experience is preferred
• 3-5 years' experience in Quality and Manufacturing Systems.
• Problem Solving Methodologies/Process Capability / ISO 13485 / Design of Experiments / Sampling Plans.
• Supplier Quality skills and experience including qualification, auditing, performance management and SCAR management.
• Experiences in providing leadership to technical teams and the use of problem-solving methodologies such as DMAIC, Ishikawa, Kepner / Tregoe etc.
• Strong technical aptitude and experience is required, with a high level of technical writing skills and ability necessary.
• Excellent communication and interpersonal skills are required.
• Ability to communicate effectively with all levels of employees throughout the organization. Able to develop and maintain strong working relationships with internal and external customers.
• Experience interacting with Regulatory Bodies (FDA, ISO) is preferred.
• Proficient in Microsoft Office, statistical software programs, operating systems, voice and email, etc.
• Ability to lead and facilitate a group of technical experts (including suppliers) in root cause investigations.
• Knowledge of quality systems and regulations for medical device industry.
• Must have a strong understanding of manufacturing and quality systems principles.
• Must be able to travel up to 25-30% domestically.

Preferred:

• Experience in Quality Systems in Medical Device and high-volume manufacturing environments.
• Engineer Certification (CQE) or Six Sigma.
• ISO 9001/ ISO 13485 Lead Auditor Certification.
• Advanced skills in statistical techniques and methods.

The Key Working Relationships

Internal Partners:

• Provides technical direction/assistance to manufacturing, engineering, product development/R&D and materials. Participates with Supply Chain in supplier contract review and contract administration for those areas regarding supplier quality.

External Partners:

• Provides technical direction/assistance to internal and external customers, subcontractors, and suppliers relative to Quidel products.

The Work Environment

The work environment characteristics are representative of an office, laboratory and manufacturing environment. Flexible work hours to meet project deadlines. Occasional travel required up to 10% of time. Travel includes airplane, automobile travel and overnight hotel.

Physical Demands

Position requires ability to travel up to 25-30% of the time. Position requires ability to lift up to 20 lbs. on occasion. Up to 50% at desk, on manufacturing floor, walking, standing, and sitting for long periods of time are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Position requires use of Personal Protective Equipment as posted.

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 $105,000 to $120,000 and is bonus eligible. 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 recruiting@quidelortho.com.