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QuidelOrtho · 6 hours ago

Quality Engineer

Carlsbad, CA

Full-time

Onsite

Entry, Mid Level

$80K/yr - $100K/yr

2+ years exp

QuidelOrtho is a world-leading in vitro diagnostics company that emphasizes employee happiness and business success. They are seeking a Quality Engineer responsible for coordinating Quality Engineering functions, supporting various departments, and ensuring compliance with quality systems and regulatory standards.

Medical Device

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

Qualification

Quality ToolsQuality Systems KnowledgeStatistical AnalysisProject ManagementAuditing ExperienceComputer SkillsCommunication SkillsTechnical Problem SolvingPrioritization SkillsTeam Collaboration

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

Benefits

Medical

Dental

Vision

Life

Disability insurance

401(k) plan

Employee assistance program

Employee Stock Purchase Plan

Paid time off (including sick time)

Paid Holidays

Company

QuidelOrtho

Glassdoor3.5

> Bringing precision and passion in everything we do QuidelOrtho stands at the forefront of testing, tracking and disease analysis of health conditions ranging from HIV and hepatitis C to flu, strep and COVID-19.

Founded in 1937

5001-10000 employees