Calibration Coordinator I

Published on: Dec 25, 2024

Country: United States

Location: Cypress, California

Company: DiaSorin Molecular LLC

Job Category: Operations

Employment type: Regular Full Time

Req ID: 6611

Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years, we've earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world.

Our broad offering of diagnostic tests and Licensed Technology solutions, made available thanks to ongoing investments in research, positions us as the player with the widest range of specialty solutions in the sector and identifies us as the "Diagnostics Specialist."

Why Join Diasorin?

Impactful Work: When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world.

Global Reach & Innovation: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry.

Diverse and Inclusive Culture: We believe in the strength of diversity, and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive, collaborative environment where everyone can thrive.

Join Our Team: If you're passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you. We're looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward.

Are you ready to be part of a dynamic team that's shaping the future of diagnostics? Join Diasorin and become a catalyst for change in the world of healthcare. Apply today and be a part of our exciting journey toward a healthier, more connected world. Together, we can make an impact!

Job Scope

Conduct and manage Calibration and Preventative Maintenance for equipment assets to ensure on-time completion. Prepare for and assist in audit activities. Generate trends, Non-conformances, temporary changes and change plans. Set goals and align metrics to business strategies. Supports all applicable regulations including but not limited to FDA, ISO, IVDD, and IVDR requirements.

Key Duties and Responsibilities

Oversee and document calibration and preventative maintenance procedures needed to result in equipment that is in good working condition, in accordance with corporate policies and in compliance with standards.
Maintain asset management system to ensure updated and current tracking of equipment assets.
Provide input into the development of preventative maintenance and calibration requirements for new and existing equipment assets.
Schedule vendors to conduct repairs, perform preventative maintenance and calibrations on equipment.
Coordinate contracts for equipment preventative maintenance, calibration and repair to assure contract agreements and work quality standards are met.
Generate trending of on-time and past-due preventative maintenance and calibrations. Communicate and report quality performance data. Provide input into preventative action plans in setting goals and alignment metrics to business strategies.
Maintain physical equipment asset files.
Ensure all equipment is entered into the asset management system in a timely manner and that the calibration/preventative maintenance schedules are effective when equipment is activated.
Control, storage and preservation of in-house calibration standards so that the accuracy and fitness for use are maintained.
Ensure calibration procedures and forms are current and up-to-date, revising when necessary.
Prepare for and assist in both external and internal audit activities.
Assist with ongoing continual improvement projects.
Comply with CFR 820.21 and ISO 13485 requirements for calibration. Updates procedures as necessary to ensure compliance to most recent standard.
Generate NCRs, temporary change notices and change plans as necessary.
Procuring supplies and services, when needed.

Education, Experience and Qualifications

Bachelor's Degree in related industry is preferred

5+ Years 2-5+ years of experience within a Quality Assurance/Engineering or Metrology organization is required

Modern office practices and procedures

Personal computer hardware and equipment

MS Word and Excel; knowledge of Google Suite

Strong knowledge of quality management systems, specifically a major preference.

Work and communicate effectively with a wide range of co-workers in a cooperative manner

Plan and manage time well

Maintain a high level of initiative, effort and commitment

Work with minimal supervision

Demonstrate responsible behavior and attention to detail

Align behavior with the needs, priorities and goals of the organization

Standard Working Conditions

Safety Glasses, lab coat, surgical gloves are some but not all PPE requirements - Occasionally

Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire.

Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process, please contact the North America Talent Acquisition Team at hrtalent@diasorin.com or 1-800-328-1482 to request an accommodation.

The above job description is intended to describe the general content, identify the essential functions, and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.

Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations.

Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen, subject to applicable laws and regulations.

This position is not eligible for partnership with a third-party search firm vendor without expressed, written consent from the Diasorin Human Resources Department.