Quality Assurance - American Surgical Company

Quality Assurance

Are you interested in advancing surgery with a higher purpose? At American Surgical Company, everything we do is aimed at a higher purpose: improving people’s lives with innovative, single-use surgical tools. Who we can help – and how we can help them – motivates us every single day.

About American Surgical Company

American Surgical Company (ASC) develops the innovative, single-use tools surgeons need to do what they do best: help their patients get better. Every day, we are advancing the future of surgery worldwide with new, specialty devices that make it possible for surgeons to improve their performance. With every tool – however small it may be – our goal is to improve patients’ lives. Sometimes, it is the tiniest things that make the biggest difference.

At ASC, we are proud of our deep expertise in small, absorbent patties. We started making products to meet the evolving needs of neurosurgeons more than 35 years ago.  Over the years, we have expanded into offerings for a whole array of medical specialties, including general surgery, head and neck surgery, oral surgery/dentistry, ophthalmology, orthopedic surgery, otolaryngology, pediatric surgery, plastic and reconstructive surgery, vascular surgery, and veterinary medicine.

Position Summary

The Quality Assurance Specialist is responsible for supporting ASC’s manufacturing program and ensuring continual quality improvement within the organization. This position supports manufacturing to resolve routine quality issues related to product manufacture and testing. This position is intended to provide full, ongoing compliance to all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations, and standards.

Responsibilities / Duties

  • Review and manage manufacturing quality events such as deviations, CAPA, NCR, and Change Control programs
  • Perform routine reviews on manufacturing batch records
  • Create, implement, review, and maintain SOPs, policies, and procedures consistent with corporate and quality objectives
  • Support internal and external audits as required
  • Executes judgement in quality issues and escalates significant issues to management
  • Supplier qualification and maintenance
  • Schedule calibration and maintenance

Qualifications

  • Associates degree, bachelor’s degree highly preferred
  • 1-3 years’ experience performing in a regulated environment highly desired, but not required
  • Proficient in English with excellent communication skills both written and verbal
  • Excellent computer and internet search skills.
  • Strong critical thinking ability
  • Effective organizational and time management skills
  • Strong attention to detail
  • Well organized, solid multitask abilities and must be able to perform under pressure/meet deadlines
  • Ability to work independently, with minimal supervision
  • offers a comprehensive benefits program including paid vacation, sick and personal time, 401(k) plan with company match, medical, life insurance, flexible health spending accounts, and more.

 



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