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.

As we continue to THRIVE we are seeking a Quality Engineer to work in our Carlsbad, location. The Quality Engineer is responsible for owning and coordinating all Quality Engineering functions and activities for the defined processes. This individual is also responsible for supporting the Production, Quality Control, Engineering and Quality Assurance departments and the associated activities, which include receiving inspection, in-process inspection, and finished goods inspection in achieving and exceeding company goals and objectives. In addition, this individual is responsible for supporting the administration, implementation, and continuous improvement of the quality systems associated with non-conforming materials (This involves seeing the product as soon as it is qualified, observing flow, interacting with personnel etc.), inspection control plans (assessing existing control plans by witnessing product qualifications, evaluating qualification equipment, troubleshooting qualification equipment etc.), and corrective/preventive action (witnessing product performance, understanding causes and support corrective action implementation). This individual also supports corporate strategic goals and objectives through internal audits, support of manufacturing operations, quality support for manufacturing processes for new product development/ product improvement projects, and support of manufacturing process improvement projects.

This position is in Carlsbad, CA.

• Process Flow Diagrams and Control Plans.

• Review, revision, and maintenance of FMEA/ Risk Analyses.

• Validations.

• Generation of protocols and support for creating validation protocols.

• Generation of master validation plans for manufacturing processes and product improvements.

• Work with Engineering to validate process components.

• Work with Engineering to develop test methods.

• Sampling plans.

• Factory/Quality Standards to support customer complaints.

• Provides technical support for departmental activities in significantly reducing product rejection, scrap, and variances, and improving both the quality and business systems inefficiencies. Collects data for development of corrective actions. Works with Manufacturing and Engineering groups to write and execute validations of process and system improvements.

• Provides technical support for the non-conforming materials function through effective technical root cause failure analysis, material dispositioning and corrective action implementation. Actively supports closed loop corrective actions through effective technical root cause failure analysis and troubleshooting investigations in resolving and precluding product, service and system failures and inefficiencies.

• Reviews procedural deviations for compliance with internal quality and external regulatory requirements. Ensure deviation proposals are appropriate, results support dispositions, and documentation is complete. Performs adequate risk assessments for deviation proposals. Maintains "Deviations" database for tracking and identification of potential Corrective Actions.

• Implements quality control support activities, such as the validation of material and process specifications, development of statistical based quality inspection control plans, support of product/process validations, and assurance of quality related deliverables within product development regulations.

• Ensures compliance of the validation system to quality and regulatory standards - supports the Validation Review Committee, reviews validation protocols and reports for completeness and compliance, provides statistical analysis of validation data, provides statistically based sampling plans.

• Contributes to the corporate efforts in support of the internal quality audit program and external supplier assessment.

• Assists in the development, implementation, and monitoring of the corporate quality system functions and culture in support of and in compliance with the Quality Policy, corporate/department goals, and external regulations.

• Performs duties in compliance with established business policies.

• Perform other work-related duties as assigned.

Required:

• B.S. in Engineering/Chemistry/Biology/Technical Discipline preferred or equivalent combination of certification and work experience.

• 2-5 years' experience in Quality and Manufacturing Systems in Medical Device or other highly regulated industries and high-volume manufacturing environments.

• Quality Tools - Problem Solving / Statistical Process Control / Process Capability / ISO 9001 / ISO 13485 / Design of Experiments / Sampling Plans.

• 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.

• Computer skills - proficient in Microsoft Office, statistical software programs, operating systems, voice, and email (not exhaustive).

• Project management, multiple tasking, and excellent prioritization skills.

• Knowledge of quality systems and regulations for the medical device industry.

• Quality Engineer should have a results-oriented commitment to the continuing evolution of the quality control system within defined regulatory and corporate requirements.

• This requires a practical, common sense knowledge base and approach in developing, implementing, and administrating the quality control system, especially as it relates to technical problem solving, implementation of 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.

Preferred:

• Auditing experience and certification strongly.

• Manufacturing - interacts with all levels of manufacturing on a regular basis on such activities as conducting product and system failure analysis, non-conforming material dispositioning, releasing product, reviewing/closing documentation, planning/implementing goals and objectives, conducting system training, implementing corrective and preventive action, performing systems assessment/feedback and supporting product/process validations.

• Engineering - interacts with the engineering staff and management on conducting technical failure analysis to resolve and preclude quality issues, developing of material and manufacturing specifications, supporting product and process validations, and supporting departmental/corporate goals and process improvements.

• R&D - provides Quality Engineering support for product development and product improvement projects by such activities as validation of material and process specifications and implementation of supplier, material, and inspection control plans.

• Materials - interacts with all levels in providing technical guidance and support for material control and compliance issues, resolving non-conforming materials, and supporting departmental/corporate goals and objectives and process improvements.

• Quality Department Management & Personnel - assists the development and improvement of department functions and personnel by providing technical support to ensure department success, increase morale and productivity to create/improve an environment that fosters continuous improvement and teamwork.

• N/A

At QuidelOrtho, our culture is shaped by four core behaviors that guide how we collaborate, make decisions, and support each other and those we serve.

The ideal candidate will exhibit these behaviors, as we believe they're essential to how we thrive as a team and achieve meaningful impact:

• Thrive Together - Collaborate intentionally, grow as a team.

• Make It Happen - Focus on priorities, embrace continuous improvement.

• Commit to Service - Cultivate a service mindset.

• Embrace Inclusion - Be open and authentic, welcome diverse perspectives

• The work environment characteristics are representative of an office, laboratory, and manufacturing environment.
• Flexible work hours to meet project deadlines.

• Requires ability to lift up to 20 lbs. on occasion.

• Up to 75% at desk, on manufacturing floor, walking, standing, and sitting for extended 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.

• Must have the ability to operate lab equipment.

• Requires use of Personal Protective Equipment as posted.

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, its is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on that facts and circumstances of each case. The salary range for this position is $79,000 to $154,000 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.

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.

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