Quality Operations Manager

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:

Under minimal supervision, the Manager, Quality Operations is responsible for managing Quality Operations personnel and processes associated with Quality Engineering and including Change Management, Risk Management, Non-conformance, Corrective and Preventative Action, Validation, and Batch Record Review. This includes responsibility for overseeing the development, implementation, maintenance, and records management associated with Change Management, Risk Management, Quality Engineering, Nonconformance, CAPA, Validation, and/or the Batch Record processes as well as any other aspects of the QMS as needed.

This position requires ability to develop, implement, evaluate, and/or modify ongoing “best practices” to assure overall quality management system (QMS) effectiveness.

This role will be located onsite in San Diego.

The Responsibilities:

• Manages and oversees the activities of the department staff; may include analysts, engineers, and/or specialists

• Manages performance of staff towards department and company goals, including but not limited to feedback on performance, appraisals, recommendations for merit increases or necessary disciplinary actions.

• Monitors performance of the Non-conformance system, Risk Management, CAPA, Validation, and Batch Record Review processes ensuring department metrics are met.

• Change Management of product, processes, and the Quality Management System.

• Manages QMS in compliance with ISO 14971, ISO 13485, and FDA 21 CFR Part 820 QSR

• Must be able to perform trend analysis on Quality Metrics and data, ensuring trends are identified and appropriate action is taken for resolution. 

• Will present department metrics to management.

• Responsible for ensuring processes are efficient, while maintaining compliance to internal procedures.

• Defines, implements, and monitors/improves batch record review process.

• Responsible for managing throughput of all reviewed Device History Records.

• Manages and maintains CofC and CofA processes and procedures for finished device lots, associated chemistries, regulatory submissions and special requests.

• Collaborates with groups within the organization to get corrections and clarifications to Device History Records.

• Ensures staff is appropriately trained to carry out duties.

• Carries out duties in compliance with established business policies and provides overall quality assurance leadership.

• Performs other duties and projects as assigned.

• Provides support and leadership during regulatory inspection activities.

• Drives execution of departmental and/or corporate strategy and goals.

• Drives Quality System Harmonization and optimization efforts

• Promotes Quality and Continuous Improvement culture

The Individual

Required:

• Bachelor’s degree in a scientific field or equivalent

• Minimum of 7 years of experience required with at least 3 years as a Lead or Supervisor or manager capacity in a quality environment

• Working knowledge of ISO 13485/MDSAP, IVDR and other applicable standards and regulations. 

• 5 years’ experience working in Quality Assurance within an ISO 13485 and/or FDA QSR regulated quality system.

• Extensive knowledge of Non-conformance, Validation, Risk Management, and CAPA processes. 

• 5 years’ experience working in a manufacturing or Quality environment.

• Solid understanding of Batch Record Review processes. 

• Advanced skills in MS Office and software systems.

• Strong understanding of manufacturing systems (documentation, compliance, inventory control, production scheduling/controls).

• Excellent written and verbal communication skills.

• 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.

Preferred:

• Masters degree in a scientific field or equivalent

• Lean Six Sigma and/or Quality certifications like Certified Quality Engineer/Certified Lead Auditor preferred

• Prior experience with electronic inventory database transactions (i.e. Oracle, JDE, etc.)

Key Working Relationships:

Frequently interacts with peers and various management levels across departments to ensure quality compliance. Interaction normally requires the ability to gain cooperation of others.

Internal Customers – Directly interacting, by such activities as document creation or revision, with internal customers and corporate partners on Quality Systems compliance and support. Respond to issues and concerns on the product and proper documentation practices.

External Customer - Directly interacting, by such activities as certificate creation or revision, with external customers and regulatory agencies.

Quality Team and other Department Personnel – Supports department personnel in achieving objectives in support of the vision and mission of the corporation and department.

The Work Environment:

The work environment characteristics are representative of office, laboratory and manufacturing environment. which may include working in varying temperature environments. Flexible work hours to meet project deadlines.

The Physical Demands:

Position requires ability to lift up to 30 lbs. on a regular basis. Typically spends 40% of time in meetings; 60% of time at the desk on computer/doing paperwork/ on phone, 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. Must be able to visually review products and ensure compliance to applicable/established Quality Standards. Position will require 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. 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 $126,000 - $145,000 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 [email protected].

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