Quality Systems Director

Alpha-Tec Systems is seeking an individual with a high attention to quality and detail to fill a Quality Systems Director role. The ideal candidate will work with upper Management to implement and enforcement quality directives across Alpha-Tec and its sister companies. This individual must have experience with FDA and ISO requirements.

Some responsibilities include:

Ensures companywide compliance in applicable city, county, state, federal, and international

regulations/certifications such as cGMP, FDA, ISO 9001, ISO 13485, and EU CE Marking for In Vitro diagnostics Directive (IVD) Registration/Certification, as needed for each site/business.

Provides leadership for developing and directing Medical Device Quality System and Quality Improvement initiatives.

Prepares documents submitted to regulatory agencies and/or certifying bodies.

Develops and oversees QS and Regulatory documentation filing systems and provides training courses related to the Quality System, ISO and FDA guidelines periodically.

Develops and maintains Medical Device Quality System policies and procedures.

Manages and hosts external regulatory and third-party inspections/audits.

Acts as the subject matter expert for ISO 13485, 9001, cGMP etc. to direct quality projects/products

Knowledge and Skills desired:

Bachelor’s degree in Microbiology, Biology, or related Life Science discipline and four years related experience and/or training; or equivalent combination of education and experience.

Must have working knowledge and a sound understanding of cGMPs, FDA QSR’s (Title 21 Part 820), and ISO 13485.

ISO 13485 and/or ISO 9001 Lead Auditor Certification desired.

Alpha-Tec is a growing medical device company, part of the CalibreScientific portfolio of life science companies. Alpha-Tec designs, manufactures, and delivers products that assist medical professionals in diagnosing infectious diseases. Our products are used throughout the globe in clinical laboratories, hospitals, universities, and within public health and government markets. At Alpha-Tec, we are firmly established and well-recognized in our industry with a brand that is synonymous with quality and customer service.

The brand-new Alpha-Tec office and manufacturing facility is located in the Columbia Tech Center (near I-205) in close proximity to restaurants, parks, coffee shops, and trails. Our Company values quality in all aspects and upholds high ethical standards; the work environment is collaborative and customer-focused with a healthy respect for employee work/life balance.

This is a full-time position, day shift, with a compensation package that includes paid time off, options for medical, dental, vision, and disability insurance, as well as a 401 (k) retirement savings plan. This position will also interface with other companies in various time zones, and may require the flexibility to travel 20% of the time.

Successful completion of a pre-employment drug test screening that matches federal standards, and a background check is required as part of our hiring process.