Quality Engineer II

QuidelOrtho•Pompano Beach, FL

1d•Onsite

About The Position

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 Role As we continue to grow as QuidelOrtho, we are seeking a Quality Engineer II. The Quality Engineer II is focused on Quality oversight of the manufacturing of in vitro diagnostic medical devices. This position has specialized knowledge of the manufacturing process and Quality Systems. The Quality Engineer II drives quality related decisions, with appropriate approval authority (both data-based and risk-assessment based decisions). The position will work to resolve quality issues by ensuring adequate root cause investigations conducted and verifying effectiveness of CAPAs implemented. The position will utilize key Quality Engineering principles, tools, and practices to develop and optimize process controls and quality system processes and identify opportunities to improve quality and cost that are aligned with the overall business goals and QuidelOrtho' s Quality Policy. The Quality Engineer II will collaborate with business partners to address quality events/nonconformances to rapidly investigate and disposition material. This role will author, document, and review quality record documentation. The Quality Engineer II will ensure audit readiness programs are effectively implemented within the organization. The work should be performed to ensure compliance with company and regulatory requirements (GMP, ISO, IVDR etc.) along with QuidelOrtho core behaviors. This role develops and maintains effective working relationships with peers and business partners. The Quality Engineer II is a problem solver and critical thinker in all aspects of the role while navigating ambiguity and range of low to moderate complexity of issues. This position is in Pompano Beach Florida.

Requirements

Bachelor of Science degree in Engineering, Science or related field of study and minimum 2-yrs experience or equivalent combination of experience and education.
Intermediate Microsoft Office (Word, Excel, PowerPoint, etc.) and statistical tools (e.g. Minitab)
Experience with establishing sample plans, quality test plans, and summarizing / reporting data analysis.
Clearly and effectively documents, communicates, and presents technical information.
Works effectively independently as well with a cross-functional team across Operations, Product Support, Compliance, Regulatory, and Suppliers.
Demonstrates a high degree of accuracy and attention to details.
Strong organization and time management skills.
Analytical and problem-solving skills with an ability to use scientific knowledge and statistical methods to identify and resolve issues.
Knowledge of current and applicable regulations including ISO13485, 21 CFR Part 820, and IVDR or equivalent experience.

Nice To Haves

American Society of Quality (ASQ) Certification

Responsibilities

Partner with operations to evaluate and address quality events including nonconformances, customer complaints, root cause investigations, and implement appropriate corrections and/or corrective actions based on risk level.
Dispositions raw materials and products in accordance with defined procedure and/or utilizing a risk-based approach.
Performs containment activities as needed.
Participates in validation and /or qualification procedures and technical reports associated with both process validation and equipment qualification activities.
Provides Quality oversight, review and approval of Change Control activities
Demonstrates problem solving skills. Identifies and resolves problems in a timely manner. Gathers and analyzes information skillfully. Develops alternative solutions effectively. Analyzes technical data and proposals.
May promote or participate in continuous improvement activities by seeking out opportunities to optimize processes and systems to reduce and control variation.
Support product and process root cause investigations by leading, facilitating, and collaborating with product support, engineering, and operations.
Support and participate in inspection readiness activities by applying working knowledge of ISO13485, 21CFR Part 820 and IVDR regulations.
Conduct product risk assessments and initiate/update Product Risk Files (i.e. FMEA’s).
Collaborate with R&D on design transfer activities / plans, that may include, but are not limited to the development of raw material specifications, process controls, and validation.
Utilize quality engineering tools and problem-solving techniques to support QO Improvement culture
May author and/or update standard operating procedures, technical reports and validation documentation.
Perform other work-related duties as assigned.