Process 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 grow, as one QuidelOrtho we are seeking a Process Validation Engineer. The Engineer prepares, organizes, gathers information for and works collaboratively with Engineering and Quality to develop Equipment qualification, verification and validation documentation and or execution of medical device automated and computerized manufacturing automated systems and ancillary equipment. Understand basic schematics and specification for installation, or investigation and repair and improvement projects. Defines, drives, and maintains document control and documentation using cGMP best practices. Maintains total compliance with all company quality, safety, and regulatory procedures and expectations.

This is an onsite position located in Pompano Beach Florida.

• Basic understanding of production medical device processes and parameters against industry standards.

• Able to analyze test data to determine the causes of defects, failure, or flaws and facilitating corrective measures.

• Establishing validation standards and developing performance testing and quality control measures to ensure equipment and processes function within acceptable parameters.

• Reviewing, oversight or verifying Calibration activities and certificates.

• Developing test procedures and validation documentation (protocols and summary reports) that produce analyzable validation data and stand-alone reports.

• Learn and perform Change Control process or operations within the company software applications.

• Performing risk assessments (FMEA and FMECA) and ensuring compliance with industry standards.

• Presenting validation test results and recommending improvements.

• Training staff on validation parameters, overseeing validation activities or execution, and documenting processes.

• Keeping informed of developments and innovation in validation engineering.

• Ensure the accurate recording of Data, according to defined engineering practices and policies.

• Performs additional work-related duties as assigned.

Required:

• Bachelor Degree in Engineering discipline or (4-5 years related experience).

• 2-3 years related experience.

• Structured Verification and Validation design.

• Meticulous attention to detail documentation.

• Capable of reading, editing, and designing electrical prints.

• Documentation / Technical report writing skills.

• Good communication skills.

• Structured Project Management capabilities.

Preferred:

• Structured problem solving methodologies.

• Working knowledge of project schedule software (e.g. MS Project).

• Six Sigma Green or Black belt.

• Lean Methodologies knowledge.

• Internal Partners: Site Head; Functional Managers/Supervisors, Site Administrative Support Personnel, Quality Assurance, Maintenance Supervision and Staff, R&D Engineering, IT

• External Partners: Transportation vendor, Utility Suppliers, Security, Cafeteria and Maintenance Contract Service Suppliers including contract review, performance and priority focus, sustained relations with key suppliers, and sourcing requirements/attainment

• Inside or outside, depending on project.

• At times Hazardous materials, fumes, toxic chemicals, airborne particles, odors, or other unpleasant surroundings

• Workspace: Traditional workspace

• Infrequent overtime, infrequent travel, and infrequent on-call

Manual dexterity to handle instruments, complete repetitive motions, and stand for long periods of time is required. Including sitting, standing, walking, bending, squatting, balancing (Maintaining body equilibrium to prevent falling when walking, standing or crouching on narrow, slippery or erratically moving surfaces.

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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