Quality Engineer

Quidel Corporation • Carlsbad, CA

29d • $79,000 - $110,000 • Onsite

About The Position

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. 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.

Requirements

• 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.

Nice To Haves

• Auditing experience and certification strongly.

Responsibilities

• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level