Technician II, Quality

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

We are seeking an experienced, high caliber Technician II, Quality
 

The Technician II, Quality is responsible for inspection and for ensuring all product specifications are met to comply with regulatory IDEV standards. Performs routine and First Article mechanical and visual inspections of procured materials, manufactured product, tooling and/or processes per IDEV documentation (drawings, specifications, procedures and workmanship standards

Responsibilities:

• Perform General Receiving inspection against specification and procedural requirements.
• Document non- conformances as appropriate
• Initiate related documentation changes.
• Perform Process Control & Monitoring of critical-to-quality parameters and specifications.
• Collect data, summarize, and document test results.
• Assist with or perform Gage R&R studies.
• Assist in writing, executing and documenting equipment, product, process, and test method verifications, qualifications, and validations.
• Employs Good Documentation Practices in all aspects of work.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Performs other related duties and responsibilities, on occasion, as assigned.

Basic Qualifications:

• Minimum High School Diploma or GED
• 2 or more years of work experience as an electro mechanical technician
• 2 or more years electrical and mechanical testing experience
• Experience with MS office suite, Word and Excel

Preferred Qualifications:

• Associates or higher degree, Technical training or additional technical certification
• Work experience in an environment that Complies with U.S. Food and Drug Administration (FDA) regulations
• Work experience within the Medical Device industry
• Previous experience in assisting with validations & qualifications, Gage R&R, calibration, test methods, and NCMR dispositioning.
• Knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulatory requirements.
• Experience with optical measurement equipment, hand tools, gages, pressure and force gage testing, and fixture design.
• Training in blueprint reading and experience with sampling techniques.
• Good communication and computer skills, including data analysis and report writing skills.
• ASQ CQT certification or equivalent preferred.