Quality Engineer II - Full-time / Part-time

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

We are seeking a Quality Engineer II to provide support to the Quality organization in validations, non-conformances and change control activities in an FDA licensed biologics manufacturing facility. This position is also responsible for approval and review of manufacturing non-conformance's while keeping into perspective the safety and efficacy of the products and business impact.This is an on site role in Pompano Beach Florida

The Responsibilities

• Provides Quality Engineering oversight for non-conformances, CAPA, validations and quality events in alignment with Ortho global policies, international law and guidance as well as site specific procedures and requirements
• Participate in validation and /or qualification procedures and technical reports associated with both process validation and equipment qualification activities
• Provide Quality oversight, review and approval of Change Control activities
• Assists in audit preparedness activities for both internal and external audits including back room and/or front room management.
• Proficient communication with both internal and external auditors.
• Participates in improvement projects.
• Author and/or update standard operating procedures.
• Performs additional work-related duties as assigned.

The Individual

• A minimum of a Bachelor's degree witha minimum of 3 years of experience at a medical or manufacturing facility; or equivalent combination of education and experience.
• Manufacturing quality experience required (e.g. experience in oversight of manufacturing non-conformances, CAPA and quality events) in a medical device, biologics, pharmaceutical or other FDA regulated fields
• ASQ certification preferred
• Must be able to apply quality engineering critical thinking while navigating ambiguous quality issues of low to moderate complexity and appropriately assess risk.
• Knowledge and application of statistical sampling plans (e.g. ANSI)
• Excellent written/verbal communication and computer skills are essential.
• Candidate should be familiar with regulations and guidelines of all applicable regulatory agencies, such as FDA (QSR/cGMP), CBER and ISO 13485.

The Key Working Relationships

Internal Partners: Partner with Manufacturing, Product Support, and Quality Teams

External Partners: Regulatory Agencies

The Work Environment:

The work environment is primarily in office.

On occasion the individual may visit a laboratory environment and include handling of viral and bacterial hazards as well as infectious or potentially infectious bodily fluids, tissues, and samples.

Position requires ability to lift to 20 lbs. on a regular basis. Walking, standing, and sitting for long periods of time (up to 75% of the day) are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Personal protective equipment is required 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. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $53,000.00 - $96,000.00 USD Annually. 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 .

#LI-AP1