Job description
Quidel’s mission is to provide patients with immediate and frequent access to highly accurate, affordable testing for the good of our families, our communities and the world. We are a leading manufacturer of point of care diagnostic solutions. Quidel’s comprehensive product portfolio includes tests for a wide range of infectious diseases, cardiac and autoimmune biomarkers, as well as a host of products to detect COVID-19.
We are excited to announce that Quidel Corporation is now becoming QuidelOrtho! This transaction will bring together two world-class teams and complementary product portfolios to serve patients around the world. During this transition period, we encourage you to continue visiting our career site and also check out more career opportunities at Careers at Ortho Clinical Diagnostics | Ortho Clinical Diagnostics jobs Join our journey as we become one global diagnostics leader!
This position 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, inspection control plans, and corrective/preventive action. 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.
Key Deliverables:
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
ESSENTIAL FUNCTIONS:
- Manufacturing Operations Support – technical support of 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.
- Non-conforming Materials/Corrective Action Systems – technical support of the non-conforming materials function through effective technical root cause failure analysis, material dispositioning and corrective action implementation. Actively support 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.
- Review procedural deviations for compliance to internal quality and external regulatory requirements. Ensure deviation proposals are appropriate, results support dispositions, and documentation is complete. Perform adequate risk assessments for deviation proposals. Maintain “Deviations” database for tracking and identification of potential Corrective Actions.
- Support of Product Development and Process Improvement Projects – 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.
- Validation System – 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.
- Internal & External Quality Audit System - actively contributes to the corporate efforts in support of the internal quality audit program and external supplier assessment.
- Quality Control Systems Strategic and Functional Planning & Implementation – assist 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.
- Carries out duties in compliance with established business policies.
Education/Experience
- Prefer a B.S. in Engineering/Chemistry/Biology/Technical Discipline 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
- Auditing experience and certification strongly preferred
Knowledge/Skills
- 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, etc.
- Project management, multiple tasking and excellent prioritization skills
- Knowledge of quality systems and regulations for medical device industry
- The 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.
Before you apply, please make sure you share Quidel’ s values. We pride ourselves on keeping these values in mind every day as we execute on goals and plan for the future. We are seeking employees who share the same mindset and commitment to be
customer driven,
focused on execution, and
new product oriented. We succeed by being
determined,
optimistic team players.
Quidel is proud to be an Affirmative Action/Equal Opportunity Employer (Minorities/Women/Disabled/Veterans). We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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