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.

As we continue to grow as QuidelOrtho, we are seeking a Staff Packaging Engineer. This is an exciting opportunity to join a team responsible for the technical management of QuidelOrtho' s packaging materials and suppliers. The Staff Packaging Engineer will be responsible for technical support for Packaging material components which serve the Raritan Manufacturing and External Operations. Major responsibility is to facilitate projects/activities as identified by Management to include manufacturing process improvement, certification, validation, change control, package integrity, design/artwork changes, cold chain, technology transfer, capacity increases etc. This position is also responsible for improvement activities/nonconformance's and associated corrective/preventive actions in support of manufacturing issues. They will be a key member on project teams to deliver high-quality packaging on schedule. The engineer will participate in the Change Control Process to update packaging specifications, Bills of Material, Master Data, and Labeling. The position would ideally suit someone with a strong background in working with packaging components or someone from a successful manufacturing engineering background looking to make a transition to Technical Operations

This position is in San Diego, CA.

• Lead component and supplier projects and activities that may include: component and supplier improvements, quality improvements, change control, closure integrity, design/artwork, cold chain and technology transfer.

• Generate Package Testing Protocols and Reports aligning to ASTM and ISTA standards.

• Provide support for certifications, validations, new molding tools and factory automation systems.

• Responsible for completing failure investigations for customer complaints, CAPA's and NC's for plant and supplier issues.

• Mentor and lead other packaging engineers. Provide project oversite and guidance.

• Work with suppliers to validate process changes, address obsolescence issues, and provide change oversight.

• Lead and execute Installation, Operational and Performance Qualifications for equipment, component, material and process changes.

• Lead cross-functional teams to improve manufacturing and packaging performance and total delivered cost.

• Maintain clear communication with internal and external business partners regarding progress, expectations, satisfaction, and/or quality of results.

• Manage component Specifications and perform component tolerance verification.

• Use detailed knowledge of business systems and processes to manage changes through the change control process.

• Use computer skills (Word, Excel, Adobe Acrobat) to revise specifications and documents, and evaluate those documents for completeness and accuracy.

• The position would ideally suit candidates who enjoy communicating with and influencing diverse stakeholders and developing cross-functional partnerships such as R&D, Strategic Sourcing, Quality, Regulatory Affairs, etc.

• Intimate knowledge of typical medical device packaging materials for components, their production, performance characteristics and typical suppliers is required.\

• Possess good knowledge of pre-press graphic artwork and printing processes as related to package components.

• It is essential that the candidate has strong decision making skills, is results driven and enjoys working to deadlines.

• Leads and or participates in large scale, multi-site projects which impact a wide variety of Package types, of which the Staff Packaging Engineer takes ownership of.

• Creates and maintains specifications, drawings, procedures and associated technical documentation for packaging components and assemblies ensuring quality standards and consistency.

• Writes Packaging Validation Protocols and Reports for the Qualification of Packaging or Shipping Lanes, recommending ASTM or ISTA standards of testing per department SOPs.

• Initiates, evaluates and executes Change Requests, Change Notices, Change Implementation plans, Controlled Document and associated technical documentation for changes in OTIS and Windchill. Independently interacts with approvers to resolve concerns.

• Provides assistance to manufacturing and warehouse personnel for packaging issues. Also, investigates any component defects with Suppliers.

• Provides mentorship to other packaging engineers.

Required:

• A minimum of 8 years medical device experience.

• Knowledge of glass vial, labels, folding carton, corrugated, and transport packaging.

• Strong written and verbal communication skills.

• Strong analytical, problem solving, insight generation and critical thinking skills.

• Self-initiator, results driven and action & detail oriented.

• Strong project / program management skills.

• Experience conducting root cause/failure investigations using formal methodologies.

• Knowledge and practical experience with process development, process controls and process validation (e.g. control plans, FMEAs, SPC, etc.)

• Ability to effectively work within a cross functional team to expedite completion of critical project tasks.

• A very good understanding of part prints and drawings.

• Excellent communication skills; making complex issues easy for others to understand and the ability to prepare communications for team and project documentation. In addition, can work independently with minimal supervision.

• Proficiency with Microsoft Office .

• Working knowledge of the validation requirements for Medical Device.

• Ability to select and execute the appropriate statistical tools and provide the practical conclusions and inferences during the process development and validation activities.

• Working knowledge of Six Sigma/Process Excellence Tools (DMAIIC, DMADV, or Lean) which include Design of Experiments, capability analysis, sampling statistics and techniques, CTQ flow down, C/E Matrix, pFMEA, fish bone diagrams, etc.

Preferred:

• Familiarity with GS1 Barcoding Standards.

• Familiarity with Adobe Illustrator.

• Candidates with experience using Minitab.

• Internal Partners: Packaging Engineers, Graphic Artists, R&D staff, Project Managers, Project Leaders, Quality, Regulatory, Project Management Office, Manufacturing, Procurement, Planning

• External Partners: Consultants, Contract employees, External partners for outsourced development / professional services, Packaging suppliers

The work environment characteristics are representative of a manufacturing, laboratory or warehouse environment and include handling of biological materials (blood pathogens) and potentially hazardous chemicals. Up to 40% of the time at desk, and 60% of the time standing or sitting for extended periods of time on the production floor/facility mobility (ex: bending, climbing ladders, etc.), and the ability to lift up to 30lbs. Flexible work hours to help Operations; will be expected to have a level of availability outside of normal business hours to help assist with permitted work for shutdown activities (confined space, crane lift, etc.), as well as emergency situations at the site should they occur.

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 $ 49,000.00 to $83,000.00. 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.

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.

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