Manufacturing Technician II

The Opportunity

Quidel Ortho 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.

At Quidel Ortho, we’re advancing the power of diagnostics for a healthier future for all. Join our mission as our next Manufacturing Technician II. Under general supervision, the scope of this position is responsible for a variety of moderately complex assembly and non-assembly functions in support of manufacturing goals.

This position will be onsite in San Diego, CA.

• Responsible for completing set-up operations for one or multiple of the following: assembly, packaging and prep operations in compliance with approved documentation and QSR

• Responsible for the completion and accuracy of moderately complex documentation associated with the manufacturing processes

• Responsible for cleaning, performing and documenting routine equipment maintenance and minor repair

• Assists in Lean Initiatives, e.g. Kaizen team, metric tracking

• Responsible for record keeping

• Responsible for supporting new equipment installation and validation

• Carries out duties in compliance with established business policies.

• May be required to successfully complete cross-training in other areas

• May be required to assist in training of temporary and manufacturing personnel

• May be required to conduct area clearance signoffs

• May be required to comprehensively review documents and sign for review check

• Perform other duties & projects as assigned

Required:

• High school diploma or equivalent required

• Two to four years of related experience required

• This position is not currently eligible for visa sponsorship.

Preferred:

• Knowledgeable of federal and other regulations, e.g. QSR’s, ISO, ISO 13485, CMDR

• Computer operated experience required

• Knowledge of MS Office and manufacturing systems required

• Experience with working with semi-automated equipment required

• Basic knowledge of GMP, Documentation Practices required

• Demonstrates commitment to the development, implementation and effectiveness of Quidel Quality Management System per ISO, FDA and other regulatory agencies

• 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

Collaborates with peers, mechanics, engineers and management to resolve technical problems. Expresses ideas and opinions objectively to peers, mechanics, engineers and management; handles conflicts maturely.

May orient new employees to work area.

Possesses the ability to effectively organize the efforts of small groups of people (5-8). Capable of assessing team performance and making recommendations for improvement. Train contract employees/peers as required.

Active involvement in group meetings – departmental and cross-functional.

The work environment characteristics are representative of a manufacturing environment and may include handling of viral and bacterial hazards as well as infectious or potentially infectious bodily fluids, tissues and samples. Flexible work hours to meet project deadlines.

Position requires ability to lift up to 50 lbs. on a regular basis. May be required to perform repetitive manufacturing processes (e.g., manual lamination, manual cassette assembly, pouch inspection, etc.) up to 90% of…