Senior Manager, Quality Assurance

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 Role

The Senior Manager, Quality Assurance is responsible for implementing and maintaining the quality management system in accordance with the Quality System Manual. This position maintains an integrated quality management system with emphasis on select systems (e.g., CAPA, Validation) and provides direction and decision-making regarding quality assurance operations. The Senior Manager, Quality Assurance provides technical leadership, guidance, and support to the site in the areas of Quality Assurance and ensures compliance to all programs, procedures, applicable regulatory, and customer requirements as well as alignment with overall strategic objectives of the department and the business.

This role is located in Athens, Ohio.

The Responsibilities 

• Provides Quality functional leadership including hiring and managing a professional, high performing quality assurance staff designed to meet the technical and compliance requirements.

• Provides strategic planning and implementation for the Quality System, including Interpretation of MDSAP/ISO/IVD/USDA medical device regulations and guidelines to determine the impact to Quality Assurance Systems.

• Provides site guidance with respect to regulations, guidelines, and emerging inspectional trends.

• Provides compliance oversight of the various site quality tools / systems to maintain an effective, compliant and validated system (e.g. MasterControl, Complaint Handling).

• Directs and manages all functions within quality assurance ensuring that each function is resourced, structured and managed to support the goals of the organization. Functional areas may include, but not limited to: CAPA, Complaint Monitoring and Trending, Validation, Training.

• Establishes and maintains departmental budgets.

• Carries out duties in compliance with established business policies.

The Individual

Required:

• BS/BA or equivalent work experience

• Minimum of 7 years of progressively more responsible experience of quality system management in medical device and high-volume manufacturing environments.

• Extensive working knowledge of quality system requirements including ISO, MDSAP, IVD regulations and have a proven track record of successfully implementing these requirements.

• Experience with document management systems.

• Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.

• Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.

• Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication.

• Demonstrated leadership skills including the ability to coach, assess, evaluate, develop, motivate and empower others.

• Demonstrated ability to successfully interact with regulatory health authorities at inspections (prior experiencing leading inspections is a must).

• Proficient in Microsoft Office suite of products (Word, Excel, PPT).

• Knowledge of process-based risk management system.

• Knowledge of Design Assurance and product-based risk management.

• Knowledge and work experience with various Quality System tools and processes, (e.g. Complaint Handling, CAPA, Validation).

• Proficiency in the English language, both written and verbal.

Preferred:

• Minimum 5 years of Quality Assurance management leadership preferred.

The Key Working Relationships

Internal Partners:

Corporate, research, regulatory, clinical, product development, information systems and operations groups.

External Partners:
outside regulatory agencies

The Work Environment

The work environment characteristics are representative of both an office and manufacturing environment. Flexible work hours to meet project deadlines. Occasional travel required. Travel includes airplane, automobile travel and overnight hotel.

The Physical Demands

No strenuous physical activity, though occasional light lifting of files and related materials is required. 50% of time in meetings, working with team, or talking on the phone, 50% of the time at the desk on computer, doing analytical work. Walking, standing, and sitting for long periods of time 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. Position may require the use of Personal Protective Equipment as posted.

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] .

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