Manager, Quality Engineering

2 weeks ago

Carlsbad, United States QuidelOrtho Full 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 Role As we continue to grow as QuidelOrtho, we are seeking a Manager, Quality Engineering. This manager will be responsible for managing the Quality Engineering resources within the Quality Control department. This role manages and performs core Quality Engineering functions such as failure investigations, New Product Introductions, NCMR, Metrology, Supplier Quality, Stability testing and Product Release. This position oversees and writes experimental protocols and reports, failure investigation reports, and supporting documentation within the Quality System (NCMRs, Complaints, CAPA, Deviations, Quality Plans etc.). This position is located on-site in Carlsbad, CA. The Responsibilities Supervises Quality Engineering employees within the stability, complaint investigation, new product introduction, product sustaining and calibration activities.

Provides leadership in performing and documenting root cause failure investigation activities, product stability evaluations, product release, nonconforming material, supplier quality, and new product introductions.

Writes, edits, and approves QC investigation reports.

Participates in Complaint Committee meetings.

Presents Failure Investigation findings to peers and management.

Mines data for development of corrective actions.

Represents the Quality Control department in evaluating failures, performing technical root cause analysis and developing and executing corrective and improvement actions.

Performs statistical analysis of data from experiments and manufacturing process trend monitoring.

Evaluates and improves Quality Control plans for optimization, matrix testing, and in-process testing of strips and components.

Supports Receiving/Inspection functions with creating and reviewing raw material specifications.

Participates in MRB.

Creates and maintains department metrics as needed.

Creates and maintains Raw Material Specifications and incoming inspection plans.

Performs other work-related duties as assigned.

The Individual Required: Bachelor of Science in Engineering/Chemistry/Biology/Technical Discipline or equivalent combination of certification and work experience.

6-8 years' experience in Quality and Manufacturing Systems in Medical Device and high-volume manufacturing environments.

Preferred: 3+ years of supervisory experience.

Master's degree.

Formal training or experience in use of DMAIC.

ASQ Quality Engineer/Manager Certification.

The Key Working Relationships Internal Partners: Manufacturing

- interacts on implementing daily inspection activity, conducting product and system failure analysis, supporting the non-conforming material system, releasing product, reviewing/closing documentation, implementing corrective and preventive action, performing systems assessment and feedback, and supporting product/process validations. Quality Assurance

- works with complaint analysis and provides input on risk-based decisions. Materials

- provides technical guidance and support for resolving non-conforming materials and process improvements. Regulatory

- Interacts to interpret regulatory requests and requirements. Technical Support

-communicates related investigation requirements. Research & Development

- works with new product introduction team and represents the Quality Control aspect of the function during introduction of new product into the market. Instrument Systems

- interacts as a part of root cause analysis. The Work Environment The work environment characteristics are representative of an office, laboratory and manufacturing environment. Flexible work hours to meet project deadlines and support of manufacturing goals. Salary Transparency 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 that facts and circumstances of each case. Salary range for this position is $108,000 to $183,000 and is bonus eligible. 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 recruiting@quidelortho.com. #LI-TO1

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