Staff Quality Engineer

The Opportunity

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.

The Opportunity

As QuidelOrtho continues to grow we are seeking a Staff Quality Engineer to support our complex quality engineering activities, to monitor and measure compliance with the Quality System Regulation, Quality policies, FDA and ISO regulations as well as product quality and compliance objectives. In addition, this role is responsible for supporting the administration, implementation, and continuous improvement of the quality systems associated with highly complex non-conforming materials, inspection control plans, and corrective/preventive action. This role 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 will be onsite at our Pompano Beach, FL location.

The Responsibilities

• Participates in complex design transfer, design control and improvement project
• Reviews/audits highly complex records, testing plans, risk analysis
• Conducts Quality training as applicable, provides coaching and guidance
• Sets strategic direction for addressing compliance issues
• Identifies improvement opportunities and leads complex, cross-functional projects creating project plans, timelines, and responsibilities matrix
• Performs root cause analysis of complex product quality issues
• Performs failure mode analysis on new or existing products, and develop mitigations for failure modes, and verify the effectiveness of these mitigations
• Develops verification and validation plans for both new products/processes and changes to existing products/processes that assess if requirements are met. Oversee the execution of verification and validation plans
• Supports the change control process by reviewing proposed changes, performing risk assessments, and assessing the adequacy of verifications and validations
• Supports the Non-Conformance and CAPA processes by performing complex investigations and root cause analysis, determining action plans and driving the actions to closure
• Carries out duties in compliance with established business policies
• Assist and/or lead audit readiness activities for both internal and external audits including back room and/or front room management.
• Performs other duties & projects as assigned

The Individual

• Bachelor’s degree in Engineering/Chemistry/Biology/Medical Technology Technical Discipline or equivalent combination of certification and work experience required.
• Master’s degree in Engineering/Chemistry/Biology/Medical Technology Technical Discipline or equivalent preferred.
• Minimum of 7 years of related experience in quality or engineering required (medical device / diagnostics preferred).
• Experience with root cause analysis, failure mode analysis, verification, and validation required.
• Statistical tools including basic statistical inference, graphical methods, statistical sampling (e.g. ANSI) required.
• ASQ (i.e. – CQE, CMQ/OE) and/or six sigma certification preferred).
• Analytical/Problem Solving Skills (e.g. statistical, risk analysis, engineering analysis).
• Advanced skills in Microsoft Office, statistical software programs, operating systems.
• Strong written and verbal communication skills (e.g. write technical reports, present data analysis) required.
• Working knowledge of FDA regulations required.
• Manufacturing quality experience in a medical device, biologics, pharmaceutical or similar FDA-regulated environment required.
• Must be able to apply critical thinking while navigating complex and ambiguous quality issues and appropriately assess risk.
• Demonstrates commitment to the development, implementation and effectiveness of Quidel Quality Management System per ISO, FDA, and other regulatory agencies.
• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
• Must have the ability to travel 10% both domestic and international.

Key Working Relationships

• Internal Partners: All levels of the organization.
• External Partners: customers and vendors.

The Working Environment

The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Up to 75% of the time at desk, standing or sitting extended periods of time. Flexible work hours to meet project deadlines.

The Physical Demands

Up to 75% at desk, on manufacturing floor, walking, standing, and sitting for long periods of time are routine to accomplish tasks in this role; 25% of time in meetings or on the phone. 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. Position requires use of Personal Protective Equipment as posted.

Salary Transparency

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. The salary range for this position is $95,000 to $115,000. 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.

Equal Employment Opportunity

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 their 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 [email protected].