Associate Quality Engineer Jobs

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 Associate Quality Engineer owns and coordinates the Quality Engineering functions and activities for the defined processes. This position supports the Production, Quality Control, Engineering and Quality Assurance departments and the associated activities, which include receiving inspection, in-process inspection, and finished goods inspection. In addition, this role supports the administration, implementation, and continuous improvement of the quality systems associated with non-conforming materials, inspection control plans, and corrective/preventive action. The Associate Quality Engineer supports corporate objectives through internal audits, support of manufacturing operations, product and process improvement projects, product qualifications and failure investigations for product complaints.

The Responsibilities

• Collects data for development of corrective actions
• Supports departmental activities in reducing product rejection, scrap and variances, and improving both the quality and business systems inefficiencies
• Works with Manufacturing and Engineering groups to write and execute validations of process and system improvements
• Maintains “Deviations” database for tracking and identification of potential Corrective Actions
• Supports of product/process validations and assurance of quality related deliverables within product development regulations
• Ensures deviation proposals are appropriate, results support dispositions, and documentation is complete. Performs adequate risk assessments for deviation proposals
• Reviews procedural deviations for compliance to internal quality and external regulatory requirements
• Supports the implementation of quality control activities, such as the validation of material and process specifications, development of statistical based quality inspection control plans
• Performs product evaluation through testing
• Supports the Validation Review Committee, reviews validation protocols and reports for completeness and compliance, provides statistical analysis of validation data, provides statistically based sampling plans

The Individual

Required

• Knowledgeable with respect to quality systems, regulatory standards, supplier/subcontractor management, manufacturing systems, product development, project management, material flows, and general production principles.
• Knowledge of quality systems and regulations for medical device industry
• Quality Tools – Problem Solving / Statistical Process Control / Process Capability / ISO 9001 / ISO 13485 / Design of Experiments / Sampling Plans / DMAIC methodology
• Computer skills – proficient in Microsoft Office, statistical software programs, operating systems, voice and email, etc.
• B.S. in Engineering/Chemistry/Biology/Technical or Science Discipline or equivalent combination of certification and work experience
• Communication Skills – Ability to communicate effectively with all levels of employees throughout the organization. Able to develop and maintain strong working relationships with internal and external customers.

Preferred

• ASQ certification
• Auditing experience
• 1-2 years of industry experience in medical device or equivalent s

The Key Working Relationships

Internal Partners:

Manufacturing, Engineering, R&D and Materials

The Work Environment

The work environment characteristics are representative of an office, laboratory and manufacturing environment. Flexible work hours to meet project deadlines. Position requires ability to lift up to 20 lbs. on occasion. Up to 75% at desk, 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 have the ability to operate lab equipment. Position requires 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 $53,600.00 to $98,000. 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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