Lead, Manufacturing Technician

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 Lead, Manufacturing Technician. Under minimal supervision, this position is responsible for a variety of assembly and non-assembly functions in support of manufacturing goals. This position is responsible for following all GMP's, safety, manufacturing and quality system procedures directly related to the manufacturing process and filling out the required supporting documentation associated with the products produced.

This position will be located onsite in San Diego, CA.

The Responsibilities

• Responsible for completing set-up operations and maintenance for assembly, packaging and prep operations in compliance with approved documentation and QSR. This will include but not limited to line clearance, inspection, bulk packaging, sampling, product measurement and testing, equipment cleaning and maintenance, and housekeeping
• Responsible for providing on-going training and guidance for other manufacturing technicians and operators
• Responsible for the ongoing FDA/ ISO compliant, cost-effective manufacture of specific products or sub-products
• Responsible for the fulfillment of daily/ weekly production schedules. Responsible for ensuring that the manufacturing processes are set-up and operating in accordance with established procedures
• Responsible for performing quality checks throughout the manufacturing process
• Responsible for the completion and accuracy of documentation associated with the manufacturing runs and equipment maintenance
• May be required to comprehensively review documents and sign for final review check
• Responsible to organize, schedule and lead other technicians and/or operators in daily manufacturing tasks; ensure compliance with safety, Lean Initiatives, quality and manufacturing procedures
• Responsible for recognizing/trouble shooting product and or equipment problems that arise during the manufacturing process
• Responsible for supporting new equipment installation and validation
• May act in a supervisory role when supervisor is absent
• Works on assignments that are complex in nature where considerable judgment and initiative are required in resolving problems and making recommendations
• Responsible for Lean Initiatives, e.g. Kaizen event leader, etc.
• Manages performance of staff towards department and Company goals, including feedback on performance
• Carries out duties in compliance with established business policies.
• Perform other duties & projects as assigned.

The Individual

Required Skills:

• High school diploma or equivalent
• Knowledgeable of federal and other regulations, e.g. QSR's, ISO, ISO 13485, CMDR
• Experience with semi-automated equipment
• Knowledge of MS Office and software systems used in manufacturing
• Ability to perform manufacturing operations with a high degree of quality, skill, and efficiency.
• Basic understanding of manufacturing systems (documentation, compliance, inventory control, production scheduling/ controls)
• Solid understanding of the product and manufacturing processes
• Strong knowledge of GMP, Documentation Practices
• Demonstrates commitment to the development, implementation and effectiveness of Quidel Quality Management System per ISO, FDA and other regulatory agencies.
• 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.

Preferred Skills:

• 4-6 year of related experience required. 2 of those years in a Lead capacity

The Key Working Relationships

Internal: Peers, mechanics, engineers and management.

External: Vendors and contractors

The Work Environment

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 50% of workday. Walking, standing, and/or sitting for long periods of time (up to 75% of the day) 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. Personal protective equipment is required 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 $ 42,900.00 - 79,000.00. 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.

EEO

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 orthorecruiting@orthoclinicaldiagnostics.com

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