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 Senior Supplier Quality Engineer should have a results-oriented commitment to the continuing evolution of supplier quality requires a practical, common sense knowledge base and approach in developing, implementing supplier improvement plans, especially as it relates to technical problem solving, implementation of supplier corrective actions, development of statistical based inspection control plans and supplier management and direct material control.
The individual must be technically knowledgeable with respect to quality systems, regulatory standards, supplier/subcontractor management, manufacturing systems, product development, project management, material flows, and general production principles. The individual is responsible for supporting the implementation and administration of departmental procedures that will affect the long-term quality and manufacturing strategies within the organization.
The Senior Supplier Quality Engineer assists in determining, implementing and improving the evolution of the corporate supplier management program, and its impact on both the strategic and daily product development and manufacturing operations. This individual is responsible for developing and implementation of departmental policies and resources into the daily functions that will affect the long-term quality, supplier relationships and business strategies for the organization. This individual must lead the efforts in resolving varying levels of quality and compliance issues independently and/or in unison within a cross functional team environment to efficiently and effectively eliminate the issue and its cause.
This position will be onsite full-time based out of Carlsbad - San Diego, Ca (Rutherford) location. With occasional visits to another manufacturing site in Sorrento Valley - San Diego, Ca.
The Responsibilities
- Evaluates current and potential suppliers for technical capability and quality system performance; understanding of supplier manufacturing processes to assist suppliers in changing those processes to improve quality while reducing cost and lead times.
- Ensures that the supplier audit program is implemented in compliance with existing procedure requirements including audit schedule and execution, supplier auditors qualifications, adequacy of audit reports, and on time closure of audit non conformances. Provide guidance and approval regarding audit strategies and approaches.
- Supports reporting of supplier performance scorecards and develop improvements to the system.
- Supports the reporting of Management Review through supplier scorecard and quality metrics.
- Conducts training with suppliers in quality tools & techniques.
- Assists suppliers in developing improved product quality, process control improvement, and in problem-solving.
- SCAR System Administration - leads efforts in managing the nonconforming material functions through effective identification, segregation, technical root cause failure analysis and disposition that result in sound corrective action at the supplier site to prevent reoccurrences.
- Raw Material Specifications and Qualification Test Plans - actively reviews existing Raw Material Specifications and their corresponding Receiving Inspection Instructions for accuracy and applicability.
- Participates on teams for new product development, inventory reduction, process improvements and supply chain management efforts representing the supplier quality function (supplier selection, assessment and approval. Qualification of new raw materials; QTP's).
- Ensures supplier files are complete and up-to-date.
- Carries out duties in compliance with established business policies.
- Perform other work-related duties as assigned.
The Individual
Required:
- Bachelor degree required, preferably in a technical field, engineering or life sciences required.
- 5-8 years of experience in Quality Systems.
- Quality Tools - Sampling Plans / Problem Solving / Statistical Process Control / ISO 9001 & 13485
- Communication Skills - 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 and suppliers.
- Project management, multiple tasking and excellent prioritization skills.
- Computer skills - proficient in Microsoft Office, statistical software programs, operating systems, voice and email, etc.
- In-depth knowledge of quality systems and regulations for medical device industry.
- Strong Problem Solving Skills.
Preferred:
- Experience in Quality Systems in Medical Device and high-volume manufacturing environments.
- Auditing experience and certification.
- Injection modeling, validation and instrumentation manufacturing experience.
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
No strenuous physical activity, though occasional light lifting of files and related materials is required up to 25 lbs. 50% of time in meetings, working with team, or talking on the phone, 50% of the time at the desk on computer, doing analytical work. 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 may require the 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